Suntasia Marketing Defendants Pay More Than $16 Million to Settle FTC Charges

Fourteen defendants involved in the massive telemarketing scheme operated by Largo, Florida-based Suntasia Marketing, Inc. have agreed to pay a total of more than $16 million to settle Federal Trade Commission charges. The funds obtained under the four settlements announced today are in addition to approximately $33 million that will be provided to Suntasia victims as part of a previously announced settlement between the Office of the Comptroller of the Currency (OCC) and Wachovia Bank, N.A., which allegedly processed thousands of unauthorized demand drafts on Suntasia’s behalf. Together, the FTC and OCC settlements will provide nearly $50 million in restitution to Suntasia’s consumer victims.

“This is a tremendous victory for consumers who were victimized by Suntasia’s deceptive negative-option telemarketing,” said Lydia Parnes, Director of the FTC’s Bureau of Consumer Protection. “The FTC, the OCC, and the Department of Justice have worked together to secure nearly $50 million for Suntasia’s victims.”

According to the FTC, between 1999 and July 2007, Suntasia deceptively marketed a series of negative option programs, including memberships in discount buyer’s and travel clubs, to nearly one million consumers nationwide. With a negative option program, a company takes consumers’ silence or failure to cancel the program as acceptance of the offer and permission to debit funds from their accounts. The FTC alleged that when Suntasia called consumers to offer supposedly “free” trial memberships in its programs, the company deceived consumers into divulging their bank account information and later charged consumers without authorization for a series of negative option programs. Federal District Court Judge James S. Moody, Jr., of the Middle District of Florida, found in entering a preliminary injunction that the telemarketing scripts Suntasia employed in selling its programs “contained misleading statements and omissions in violation of the FTC Act and the [Telemarketing Sales Rule].”

Consumers complained in near-record numbers about Suntasia’s practices. The FTC collected more than 5,000 formal complaints that consumers submitted to various law enforcement agencies and the Better Business Bureau. The FTC also found in Suntasia’s possession thousands of additional complaint letters and refund requests that consumers submitted to the company directly. In addition to providing over $16 million in restitution to these victims, the four court orders announced today bar the defendants from making the false statements alleged in the complaint, from failing to disclose material information about their programs, and from further violating the FTC’s Telemarketing Sales Rule (TSR).

The court actions announced today settle the charges brought in the FTC’s July 2007 complaint against defendants FTN Promotions, Inc.; Guardian Marketing Services, Corp.; Strategia Marketing, LLC; Co-Compliance, LLC; Bay Pines Travel, Inc.; Suntasia Properties, Inc.; JPW Consultants, Inc.; Travel Agents Direct, LLC; Bryon W. Wolf; Roy A. Eliasson; Alfred H. Wolf; Jeffrey P. Wolf; John Louis Smith II, and Donald L. Booth.

According to the FTC, Suntasia Marketing, Inc., based in Largo, Florida, used at least fifteen different business names to defraud consumers across the U.S. out of approximately $172 million. Eight interrelated companies employing more than 1,000 people ran the scheme, which injured up to a million consumers nationwide.

According to the FTC’s complaint, Suntasia telemarketers began their deceptive sales pitch by misrepresenting that Suntasia was affiliated with consumers’ banks. The telemarketers then offered consumers a series of “free gifts” and quickly attempted to obtain their bank account numbers. Suntasia telemarketers indicated that they needed to “verify” this information to confirm consumers’ eligibility to receive the purportedly free gifts.” Having already pretended to be affiliated with consumers’ banks, the telemarketers then purported to already possess consumers’ bank account numbers, asking that consumers merely “confirm” their information.

The FTC contends many consumers disclosed their account numbers believing that they were simply verifying information that the telemarketers already had. The FTC also alleged that consumers frequently thought their account number was being “verified” solely to confirm their eligibility to receive the free gifts, not to authorize any future charges to their accounts. These false bank affiliation claims, the FTC alleged, were central to Suntasia’s scheme.

In addition, the FTC charged that the defendants misrepresented, or did not disclose, various aspects of their programs relating to if and when consumers would be charged, the operation of the alleged free trial period, and their cancellation policy. The complaint also alleged that the defendants had illegally purchased leads containing consumers’ unencrypted bank account numbers for use in telemarketing.

Terms of the Consent Orders

The four stipulated orders announced today contain provisions to ensure the defendants do not engage in similar illegal acts in the future. The orders bar the defendants, in connection with the advertising, promoting, offering for sale, or sale of any product or service, from misrepresenting any material fact, including, but not limited to: 1) an affiliation with a consumer’s bank or other third party; 2) the purpose for which the consumer’s billing information will be used; 3) whether they already have the consumer’s billing information; 4) that a product or service is offered on a “free” or “no obligation” basis, when, in fact charges will be assessed if the consumer fails to take affirmative action; 5) the length of any free trial period; 6) that the trial period will not begin until the consumer has received informational material in the mail; 7) the amount a consumer will be charged or billed; 8) that a consumer will not be charged or billed; 9) that a consumer has agreed to purchase a product or has authorized a transaction; 10) that a consumer will not be charged or billed without their authorization; and 11) the material terms and conditions of any refund or cancellation policies.

In addition, the orders require the defendants to disclose clearly and conspicuously, before consumers are asked to reveal their billing information: 1) all fees and costs of a product or service; 2) all material conditions, limitations, restrictions applicable to the purchase (including any provisions associated with “free” products or services); 3) the dollar amount of the first payment and when it will be charged; 4) whether a charge will be submitted for payment at the end of a trial period unless the consumer cancels and the details of the trial period; 5) all material conditions, limitations, and restrictions on the consumer’s ability to use any trial membership or related product; and 6) all material conditions, limitations, and restrictions on a consumer’s ability to use any product or service offered as “free” or with “no obligation.”

The orders also bar the defendants from causing billing information to be submitted for payment without the express informed consent of the consumer and requires them to get a consumer’s written or oral consent to sign up for a negative-option program. They also must record these agreements and provide them to the consumer upon request.

Finally, the orders prohibit the defendants from violating the TSR or assisting anyone else in doing so. Specifically, the orders bar the defendants from misrepresenting an affiliation with a third party such as a bank, from failing to disclose the material terms and conditions of their negative option offers, from billing consumers for goods or services without their express informed consent, and from purchasing unencrypted consumer account numbers for use in telemarketing.

The more than $16 million in consumer redress required under the four settlements is comprised of the following:

  • Defendants FTN Promotions, Inc.; Guardian Marketing Services, Corp.; Strategia Marketing, LLC; Co-Compliance, LLC; Bay Pines Travel, Inc.; Suntasia Properties, Inc.; Bryon W. Wolf; and Roy A. Eliasson must pay over $11.25 million in consumer redress;
  • Those defendants also must turn over real and personal property worth approximately $3.1 million, including the Largo facility where they operated their business;
  • Defendants JPW Consultants, Inc.; Jeffrey P. Wolf; and Alfred H. Wolf must liquidate and turn over to the FTC the proceeds of two securities accounts valued in July 2007 at $2 million;
  • Defendants Travel Agents Direct LLC and John Louis Smith II must jointly pay $25,000 in consumer redress;
  • Defendant Donald L. Booth must pay $35,000 in consumer redress; and
  • Bryon Wolf and Roy Eliasson also are required to turn over to the FTC any tax refunds they may derive as a result of making the above redress payments, which may later add as much as $2 million to the consumer redress pool.

In the course of the litigation, the court-appointed receiver also sold Suntasia’s 80-foot corporate yacht and a second telemarketing facility the defendants were building in St. Petersburg, Florida.

The orders include a $171.9 million suspended judgment against defendants FTN Promotions, Inc.; Guardian Marketing Services, Corp. Strategia Marketing, LLC; Co-Compliance, LLC; Bay Pines Travel, Inc.; Suntasia Properties, Inc.; Bryon W. Wolf; and Roy A. Eliasson. The $171.9 million judgment is suspended upon the defendants’ satisfaction of their redress obligations, due to the defendants’ inability to pay the entire judgment. If the defendants are later found to have misrepresented their financial status, they will be responsible for paying the full amount of the judgment. Suspended judgments also were entered against JPW Consultants, Inc., and Jeffrey P. Wolf for $60 million, and against Alfred H. Wolf for $115 million.

The Commission vote approving the consent in settlement of the court action with each defendant was 4-0. Three of the stipulated orders were entered by the U.S. District Court for the Middle District of Florida, Tampa Division, on December 30, 2008. The court entered the stipulated order against Donald L. Booth on August 27, 2008.

The FTC received invaluable assistance in this matter from the United States Postal Inspection Service, the Largo, Florida Police Department, the Better Business Bureau of West Florida, Inc., the Pinellas County Department of Justice and Consumer Services, the University of Central Florida Police Department, the Miami-Dade Police Department, and the Department of Commerce’s Office of Export Enforcement.

Wachovia Bank Redress Program

For more information on the restitution that is being provided to Suntasia victims as a result of the settlement between the OCC and Wachovia Bank, N.A., including information on Wachovia’s recently issued checks to consumers, please see http://www.ftc.gov/opa/2009/01/wachovia.shtm.

NOTE: Stipulated final judgments and orders are for settlement purposes only and do not constitute an admission by the defendants of a law violation. Consent judgments have the force of law when signed by the judge.

Copies of the stipulated final judgments are available from the FTC’s Web site at http://www.ftc.gov and also from the FTC’s Consumer Response Center, Room 130, 600 Pennsylvania Avenue, N.W., Washington, DC 20580. The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them. To file a complaint in English or Spanish, visit the FTC’s online Complaint Assistant or call 1-877-FTC-HELP (1-877-382-4357). The FTC enters complaints into Consumer Sentinel, a secure, online database available to more than 1,500 civil and criminal law enforcement agencies in the U.S. and abroad. The FTC’s Web site provides free information on a variety of consumer topics.

(FTC File No. X070036; Civ. No. 8:07-cv-1279-T-30TGW)
(Suntasia.final.wpd)

Suntasia Marketing Defendants Pay More Than $16 Million to Settle FTC Charges

Fourteen defendants involved in the massive telemarketing scheme operated by Largo, Florida-based Suntasia Marketing, Inc. have agreed to pay a total of more than $16 million to settle Federal Trade Commission charges. The funds obtained under the four settlements announced today are in addition to approximately $33 million that will be provided to Suntasia victims as part of a previously announced settlement between the Office of the Comptroller of the Currency (OCC) and Wachovia Bank, N.A., which allegedly processed thousands of unauthorized demand drafts on Suntasia’s behalf. Together, the FTC and OCC settlements will provide nearly $50 million in restitution to Suntasia’s consumer victims.

“This is a tremendous victory for consumers who were victimized by Suntasia’s deceptive negative-option telemarketing,” said Lydia Parnes, Director of the FTC’s Bureau of Consumer Protection. “The FTC, the OCC, and the Department of Justice have worked together to secure nearly $50 million for Suntasia’s victims.”

According to the FTC, between 1999 and July 2007, Suntasia deceptively marketed a series of negative option programs, including memberships in discount buyer’s and travel clubs, to nearly one million consumers nationwide. With a negative option program, a company takes consumers’ silence or failure to cancel the program as acceptance of the offer and permission to debit funds from their accounts. The FTC alleged that when Suntasia called consumers to offer supposedly “free” trial memberships in its programs, the company deceived consumers into divulging their bank account information and later charged consumers without authorization for a series of negative option programs. Federal District Court Judge James S. Moody, Jr., of the Middle District of Florida, found in entering a preliminary injunction that the telemarketing scripts Suntasia employed in selling its programs “contained misleading statements and omissions in violation of the FTC Act and the [Telemarketing Sales Rule].”

Consumers complained in near-record numbers about Suntasia’s practices. The FTC collected more than 5,000 formal complaints that consumers submitted to various law enforcement agencies and the Better Business Bureau. The FTC also found in Suntasia’s possession thousands of additional complaint letters and refund requests that consumers submitted to the company directly. In addition to providing over $16 million in restitution to these victims, the four court orders announced today bar the defendants from making the false statements alleged in the complaint, from failing to disclose material information about their programs, and from further violating the FTC’s Telemarketing Sales Rule (TSR).

The court actions announced today settle the charges brought in the FTC’s July 2007 complaint against defendants FTN Promotions, Inc.; Guardian Marketing Services, Corp.; Strategia Marketing, LLC; Co-Compliance, LLC; Bay Pines Travel, Inc.; Suntasia Properties, Inc.; JPW Consultants, Inc.; Travel Agents Direct, LLC; Bryon W. Wolf; Roy A. Eliasson; Alfred H. Wolf; Jeffrey P. Wolf; John Louis Smith II, and Donald L. Booth.

According to the FTC, Suntasia Marketing, Inc., based in Largo, Florida, used at least fifteen different business names to defraud consumers across the U.S. out of approximately $172 million. Eight interrelated companies employing more than 1,000 people ran the scheme, which injured up to a million consumers nationwide.

According to the FTC’s complaint, Suntasia telemarketers began their deceptive sales pitch by misrepresenting that Suntasia was affiliated with consumers’ banks. The telemarketers then offered consumers a series of “free gifts” and quickly attempted to obtain their bank account numbers. Suntasia telemarketers indicated that they needed to “verify” this information to confirm consumers’ eligibility to receive the purportedly free gifts.” Having already pretended to be affiliated with consumers’ banks, the telemarketers then purported to already possess consumers’ bank account numbers, asking that consumers merely “confirm” their information.

The FTC contends many consumers disclosed their account numbers believing that they were simply verifying information that the telemarketers already had. The FTC also alleged that consumers frequently thought their account number was being “verified” solely to confirm their eligibility to receive the free gifts, not to authorize any future charges to their accounts. These false bank affiliation claims, the FTC alleged, were central to Suntasia’s scheme.

In addition, the FTC charged that the defendants misrepresented, or did not disclose, various aspects of their programs relating to if and when consumers would be charged, the operation of the alleged free trial period, and their cancellation policy. The complaint also alleged that the defendants had illegally purchased leads containing consumers’ unencrypted bank account numbers for use in telemarketing.

Terms of the Consent Orders

The four stipulated orders announced today contain provisions to ensure the defendants do not engage in similar illegal acts in the future. The orders bar the defendants, in connection with the advertising, promoting, offering for sale, or sale of any product or service, from misrepresenting any material fact, including, but not limited to: 1) an affiliation with a consumer’s bank or other third party; 2) the purpose for which the consumer’s billing information will be used; 3) whether they already have the consumer’s billing information; 4) that a product or service is offered on a “free” or “no obligation” basis, when, in fact charges will be assessed if the consumer fails to take affirmative action; 5) the length of any free trial period; 6) that the trial period will not begin until the consumer has received informational material in the mail; 7) the amount a consumer will be charged or billed; 8) that a consumer will not be charged or billed; 9) that a consumer has agreed to purchase a product or has authorized a transaction; 10) that a consumer will not be charged or billed without their authorization; and 11) the material terms and conditions of any refund or cancellation policies.

In addition, the orders require the defendants to disclose clearly and conspicuously, before consumers are asked to reveal their billing information: 1) all fees and costs of a product or service; 2) all material conditions, limitations, restrictions applicable to the purchase (including any provisions associated with “free” products or services); 3) the dollar amount of the first payment and when it will be charged; 4) whether a charge will be submitted for payment at the end of a trial period unless the consumer cancels and the details of the trial period; 5) all material conditions, limitations, and restrictions on the consumer’s ability to use any trial membership or related product; and 6) all material conditions, limitations, and restrictions on a consumer’s ability to use any product or service offered as “free” or with “no obligation.”

The orders also bar the defendants from causing billing information to be submitted for payment without the express informed consent of the consumer and requires them to get a consumer’s written or oral consent to sign up for a negative-option program. They also must record these agreements and provide them to the consumer upon request.

Finally, the orders prohibit the defendants from violating the TSR or assisting anyone else in doing so. Specifically, the orders bar the defendants from misrepresenting an affiliation with a third party such as a bank, from failing to disclose the material terms and conditions of their negative option offers, from billing consumers for goods or services without their express informed consent, and from purchasing unencrypted consumer account numbers for use in telemarketing.

The more than $16 million in consumer redress required under the four settlements is comprised of the following:

  • Defendants FTN Promotions, Inc.; Guardian Marketing Services, Corp.; Strategia Marketing, LLC; Co-Compliance, LLC; Bay Pines Travel, Inc.; Suntasia Properties, Inc.; Bryon W. Wolf; and Roy A. Eliasson must pay over $11.25 million in consumer redress;
  • Those defendants also must turn over real and personal property worth approximately $3.1 million, including the Largo facility where they operated their business;
  • Defendants JPW Consultants, Inc.; Jeffrey P. Wolf; and Alfred H. Wolf must liquidate and turn over to the FTC the proceeds of two securities accounts valued in July 2007 at $2 million;
  • Defendants Travel Agents Direct LLC and John Louis Smith II must jointly pay $25,000 in consumer redress;
  • Defendant Donald L. Booth must pay $35,000 in consumer redress; and
  • Bryon Wolf and Roy Eliasson also are required to turn over to the FTC any tax refunds they may derive as a result of making the above redress payments, which may later add as much as $2 million to the consumer redress pool.

In the course of the litigation, the court-appointed receiver also sold Suntasia’s 80-foot corporate yacht and a second telemarketing facility the defendants were building in St. Petersburg, Florida.

The orders include a $171.9 million suspended judgment against defendants FTN Promotions, Inc.; Guardian Marketing Services, Corp. Strategia Marketing, LLC; Co-Compliance, LLC; Bay Pines Travel, Inc.; Suntasia Properties, Inc.; Bryon W. Wolf; and Roy A. Eliasson. The $171.9 million judgment is suspended upon the defendants’ satisfaction of their redress obligations, due to the defendants’ inability to pay the entire judgment. If the defendants are later found to have misrepresented their financial status, they will be responsible for paying the full amount of the judgment. Suspended judgments also were entered against JPW Consultants, Inc., and Jeffrey P. Wolf for $60 million, and against Alfred H. Wolf for $115 million.

The Commission vote approving the consent in settlement of the court action with each defendant was 4-0. Three of the stipulated orders were entered by the U.S. District Court for the Middle District of Florida, Tampa Division, on December 30, 2008. The court entered the stipulated order against Donald L. Booth on August 27, 2008.

The FTC received invaluable assistance in this matter from the United States Postal Inspection Service, the Largo, Florida Police Department, the Better Business Bureau of West Florida, Inc., the Pinellas County Department of Justice and Consumer Services, the University of Central Florida Police Department, the Miami-Dade Police Department, and the Department of Commerce’s Office of Export Enforcement.

Wachovia Bank Redress Program

For more information on the restitution that is being provided to Suntasia victims as a result of the settlement between the OCC and Wachovia Bank, N.A., including information on Wachovia’s recently issued checks to consumers, please see http://www.ftc.gov/opa/2009/01/wachovia.shtm.

NOTE: Stipulated final judgments and orders are for settlement purposes only and do not constitute an admission by the defendants of a law violation. Consent judgments have the force of law when signed by the judge.

Copies of the stipulated final judgments are available from the FTC’s Web site at http://www.ftc.gov and also from the FTC’s Consumer Response Center, Room 130, 600 Pennsylvania Avenue, N.W., Washington, DC 20580. The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them. To file a complaint in English or Spanish, visit the FTC’s online Complaint Assistant or call 1-877-FTC-HELP (1-877-382-4357). The FTC enters complaints into Consumer Sentinel, a secure, online database available to more than 1,500 civil and criminal law enforcement agencies in the U.S. and abroad. The FTC’s Web site provides free information on a variety of consumer topics.

(FTC File No. X070036; Civ. No. 8:07-cv-1279-T-30TGW)
(Suntasia.final.wpd)

FTC Announces Agenda for Conference on Securing Personal Data in the Global Economy

The Federal Trade Commission has announced the agenda for an upcoming two-day international conference titled “Securing Personal Data in the Global Economy.” The conference, which the FTC will host in conjunction with two international organizations, takes place March 16 and 17, 2009 and addresses how companies can manage personal data-security issues in a global information environment where data can be stored and accessed from multiple jurisdictions.

Co-sponsors of the conference, which the FTC first announced last month, are the Asia-Pacific Economic Cooperation (APEC) forum and the Organisation for Economic Co-operation and Development (OECD). The conference will include a series of moderated panel discussions; audience participation is encouraged. People interested in participating in the conference as speakers may enquire by e-mail to [email protected]. Pre-registration is not required.

The conference agenda addresses: data security and the law; data security practices in industry; best practices for responding to data breaches; data flows and cross-border conflicts; a case study; and a wrap-up discussion on current and future trends. The agenda can be found as a link to this press release on the FTC’s Web site. For the most up-to-date information about the conference, visit the conference Web site at http://www.ftc.gov/bcp/workshops/personaldataglobal/index.shtm.

The conference, which is to be webcast, will be held in Washington, DC at the FTC’s satellite building at 601 New Jersey Avenue, NW. It will take place after the International Association of Privacy Professionals (IAPP) Privacy Summit is held in the same city.

The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them. To file a complaint in English or Spanish, visit the FTC’s online Complaint Assistant or call 1-877-FTC-HELP (1-877-382-4357). The FTC enters complaints into Consumer Sentinel, a secure, online database available to more than 1,500 civil and criminal law enforcement agencies in the U.S. and abroad. The FTC’s Web site provides free information on a variety of consumer topics.

FTC Announces Agenda for Conference on Securing Personal Data in the Global Economy

The Federal Trade Commission has announced the agenda for an upcoming two-day international conference titled “Securing Personal Data in the Global Economy.” The conference, which the FTC will host in conjunction with two international organizations, takes place March 16 and 17, 2009 and addresses how companies can manage personal data-security issues in a global information environment where data can be stored and accessed from multiple jurisdictions.

Co-sponsors of the conference, which the FTC first announced last month, are the Asia-Pacific Economic Cooperation (APEC) forum and the Organisation for Economic Co-operation and Development (OECD). The conference will include a series of moderated panel discussions; audience participation is encouraged. People interested in participating in the conference as speakers may enquire by e-mail to [email protected]. Pre-registration is not required.

The conference agenda addresses: data security and the law; data security practices in industry; best practices for responding to data breaches; data flows and cross-border conflicts; a case study; and a wrap-up discussion on current and future trends. The agenda can be found as a link to this press release on the FTC’s Web site. For the most up-to-date information about the conference, visit the conference Web site at http://www.ftc.gov/bcp/workshops/personaldataglobal/index.shtm.

The conference, which is to be webcast, will be held in Washington, DC at the FTC’s satellite building at 601 New Jersey Avenue, NW. It will take place after the International Association of Privacy Professionals (IAPP) Privacy Summit is held in the same city.

The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them. To file a complaint in English or Spanish, visit the FTC’s online Complaint Assistant or call 1-877-FTC-HELP (1-877-382-4357). The FTC enters complaints into Consumer Sentinel, a secure, online database available to more than 1,500 civil and criminal law enforcement agencies in the U.S. and abroad. The FTC’s Web site provides free information on a variety of consumer topics.

FTC Charges Indiana Firm with Failing to Live Up to Rebate Promises

The Federal Trade Commission today announced a complaint against an Indiana-based firm and its president for failing to pay rebates due to thousands of consumers nationwide within the time promised, and leaving many others with no rebate checks at all for the computer equipment and other electronics they purchased. Under the terms of a proposed court order settling the Commission’s charges, the defendants, who are repeat offenders, would be barred from any involvement in the development, marketing, fulfillment, or funding of any rebate program. They also would be subject to a suspended monetary judgment of more than $330,000. The proposed settlement’s provisions are among the strongest ever imposed by the FTC in a rebate-related case.

According to the Commission’s complaint, since April 2006, the defendants have disseminated rebate forms for mail-in rebates that included language such as:

Get $100 Back by mail
Hanns-G 19″ LCD Monitor
It’s Fast & Easy
. . . .
Allow at least 10 weeks for processing; and

Get $100 Back by mail
Hanns-G 19″ LCD Monitor
It’s Fast & Easy
. . . .
Allow at least 10 weeks for processing

The purported rebates were for computer-related hardware and other electronics equipment advertised, offered for sale, and sold by Market Development Specialists (MDS), doing business as Wintergreen Systems, and its president John Levy. The Commission contends that MDS acted as a re-seller of many products, including monitors and portable DVD players. MDS distributed these products to the public through retailers including Office Depot, PC Connection, Buy.com, PCMall, and Woot.com. To make its products more attractive to retailers, it offered many mail-in rebates ranging in value from $20 to $150.

Some consumers who bought MDS’s products and applied for rebates, however, found they were in for a long wait – in some cases up to two years – to get their money. In other cases, the defendants never mailed rebate checks to consumers who bought the advertised products, and while consumers did receive rebate checks, thousands of payments were delayed up to 10 weeks or longer. The Commission therefore charged the defendants with violating the FTC Act by engaging in unfair or deceptive acts or practices in or affecting commerce.

The proposed order settling the FTC’s charges contains both strong injunctive and monetary relief. First, it bans Levy and Wintergreen from “any involvement in the development, marketing, fulfillment, or funding of any rebate program” to ensure they do not engage in conduct similar to that alleged in the complaint in the future. The ban is accompanied by another provision that applies to future claims the defendants make regarding any type of promotional premium or bonus.

The provision prohibits them from making any misrepresentations regarding any “bonus,” which is defined as “any premium, gift, award or other consideration (whether in the form of cash, credit, merchandise, or any equivalent) given or offered to a consumer in exchange for purchasing a product or service.” The Commission believes such strong fencing-in relief is appropriate because Levy is a recidivist, having violated an April 2006 assurance of voluntary compliance with the State of Indiana related to his rebate practices.

Under the proposed order, the defendants would face a judgment of $330,240, an amount equal to the value of all rebates owed to consumers as a result of their alleged conduct. While this judgment has been suspended based on the defendants’ inability to pay, it will become due if they are later found to have misrepresented their financial condition. Finally, the proposed order contains standard monitoring, reporting, and record keeping requirements to ensure the defendants’ compliance with its terms.

The proposed court order announced today settles the FTC’s charges against the following defendants: Market Development Specialist, Inc., d/b/a Wintergreen Systems, and John Levy, individually and as an officer of Market Development Specialists, Inc.

The Commission vote authorizing the filing of the complaint and stipulated final order in consent of the court action was 4-0. The complaint and proposed order were filed the U.S. District Court for the Northern District of California, San Francisco Division, on January 12, 2009.

NOTE: The Commission authorizes the filing of a complaint when it has “reason to believe” that the law has been or is being violated, and it appears to the Commission that a proceeding is in the public interest. The complaint is not a finding or ruling that the defendant actually has violated the law. The case will be decided by the court.

NOTE: This stipulated final order is for settlement purposes only and does not constitute an admission by the defendant of a law violation. A stipulated final order requires approval by the court and has the force of law when signed by the judge.

Copies of the stipulated final order are available from the FTC’s Web site at http://www.ftc.gov and from the FTC’s Consumer Response Center, Room 130, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580. The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them. To file a complaint in English or Spanish, visit the FTC’s online Complaint Assistant or call 1-877-FTC-HELP (1-877-382-4357). The FTC enters complaints into Consumer Sentinel, a secure, online database available to more than 1,500 civil and criminal law enforcement agencies in the U.S. and abroad. The FTC’s Web site provides free information on a variety of consumer topics.

(Market Development.final.wpd)
(FTC File No. 072-3201; Civ. No. 09-0124)

FTC Charges Indiana Firm with Failing to Live Up to Rebate Promises

The Federal Trade Commission today announced a complaint against an Indiana-based firm and its president for failing to pay rebates due to thousands of consumers nationwide within the time promised, and leaving many others with no rebate checks at all for the computer equipment and other electronics they purchased. Under the terms of a proposed court order settling the Commission’s charges, the defendants, who are repeat offenders, would be barred from any involvement in the development, marketing, fulfillment, or funding of any rebate program. They also would be subject to a suspended monetary judgment of more than $330,000. The proposed settlement’s provisions are among the strongest ever imposed by the FTC in a rebate-related case.

According to the Commission’s complaint, since April 2006, the defendants have disseminated rebate forms for mail-in rebates that included language such as:

Get $100 Back by mail
Hanns-G 19″ LCD Monitor
It’s Fast & Easy
. . . .
Allow at least 10 weeks for processing; and

Get $100 Back by mail
Hanns-G 19″ LCD Monitor
It’s Fast & Easy
. . . .
Allow at least 10 weeks for processing

The purported rebates were for computer-related hardware and other electronics equipment advertised, offered for sale, and sold by Market Development Specialists (MDS), doing business as Wintergreen Systems, and its president John Levy. The Commission contends that MDS acted as a re-seller of many products, including monitors and portable DVD players. MDS distributed these products to the public through retailers including Office Depot, PC Connection, Buy.com, PCMall, and Woot.com. To make its products more attractive to retailers, it offered many mail-in rebates ranging in value from $20 to $150.

Some consumers who bought MDS’s products and applied for rebates, however, found they were in for a long wait – in some cases up to two years – to get their money. In other cases, the defendants never mailed rebate checks to consumers who bought the advertised products, and while consumers did receive rebate checks, thousands of payments were delayed up to 10 weeks or longer. The Commission therefore charged the defendants with violating the FTC Act by engaging in unfair or deceptive acts or practices in or affecting commerce.

The proposed order settling the FTC’s charges contains both strong injunctive and monetary relief. First, it bans Levy and Wintergreen from “any involvement in the development, marketing, fulfillment, or funding of any rebate program” to ensure they do not engage in conduct similar to that alleged in the complaint in the future. The ban is accompanied by another provision that applies to future claims the defendants make regarding any type of promotional premium or bonus.

The provision prohibits them from making any misrepresentations regarding any “bonus,” which is defined as “any premium, gift, award or other consideration (whether in the form of cash, credit, merchandise, or any equivalent) given or offered to a consumer in exchange for purchasing a product or service.” The Commission believes such strong fencing-in relief is appropriate because Levy is a recidivist, having violated an April 2006 assurance of voluntary compliance with the State of Indiana related to his rebate practices.

Under the proposed order, the defendants would face a judgment of $330,240, an amount equal to the value of all rebates owed to consumers as a result of their alleged conduct. While this judgment has been suspended based on the defendants’ inability to pay, it will become due if they are later found to have misrepresented their financial condition. Finally, the proposed order contains standard monitoring, reporting, and record keeping requirements to ensure the defendants’ compliance with its terms.

The proposed court order announced today settles the FTC’s charges against the following defendants: Market Development Specialist, Inc., d/b/a Wintergreen Systems, and John Levy, individually and as an officer of Market Development Specialists, Inc.

The Commission vote authorizing the filing of the complaint and stipulated final order in consent of the court action was 4-0. The complaint and proposed order were filed the U.S. District Court for the Northern District of California, San Francisco Division, on January 12, 2009.

NOTE: The Commission authorizes the filing of a complaint when it has “reason to believe” that the law has been or is being violated, and it appears to the Commission that a proceeding is in the public interest. The complaint is not a finding or ruling that the defendant actually has violated the law. The case will be decided by the court.

NOTE: This stipulated final order is for settlement purposes only and does not constitute an admission by the defendant of a law violation. A stipulated final order requires approval by the court and has the force of law when signed by the judge.

Copies of the stipulated final order are available from the FTC’s Web site at http://www.ftc.gov and from the FTC’s Consumer Response Center, Room 130, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580. The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them. To file a complaint in English or Spanish, visit the FTC’s online Complaint Assistant or call 1-877-FTC-HELP (1-877-382-4357). The FTC enters complaints into Consumer Sentinel, a secure, online database available to more than 1,500 civil and criminal law enforcement agencies in the U.S. and abroad. The FTC’s Web site provides free information on a variety of consumer topics.

(Market Development.final.wpd)
(FTC File No. 072-3201; Civ. No. 09-0124)

Bureau of Consumer Protection Director Parnes To Leave FTC

Federal Trade Commission Chairman William E. Kovacic announced today that Lydia B. Parnes, Director of the Bureau of Consumer Protection, will leave the agency after 27 years to enter private law practice, and that Eileen Harrington, currently BCP Deputy Director, will serve as Acting Director.

“Since the early 1980s, no one has contributed more to the FTC’s success than Lydia,” Chairman Kovacic said. “She has played a crucial role in developing and implementing programs that have made the Commission second to none among the world’s consumer protection agencies. Under her graceful and intelligent guidance, the Bureau has built and maintained a culture of excellence, dedication, innovation, and intellectual rigor.”

Parnes, who joined the agency in 1981, will join Wilson Sonsini Goodrich & Rosati in its Washington, DC office.

The Bureau of Consumer Protection enforces consumer protection laws and trade regulation rules, investigates business practices, sues law violators, develops rules to protect consumers, and provides consumer and business education. As Bureau Director, and as Deputy Director from 1992 until she became Director in 2004, Parnes helped lead many of the Bureau’s signature efforts, including the National Do Not Call Registry, the Telemarketing Sales Rule, an award-winning data security and privacy program, innovative consumer and business education, and the Consumer Sentinel, a database of consumer complaints available to more than 1,700 law enforcement organizations in the U.S., Canada, and Australia. She also helped guide an expansion of the Bureau’s financial practices and order enforcement programs, an expansion of litigation under Section 13(b) of the FTC Act, and integrated strategic planning.

Parnes joined the agency as an attorney advisor to Chairman James C. Miller III. She served as Associate Director of the Division of Marketing Practices from 1987 to 1992, and as Assistant Director of the Division of Policy and Evaluation from 1985 to 1987. Parnes is a graduate of the Washington College of Law at American University and received her undergraduate degree from American University.

Harrington has served as the Bureau’s Deputy Director since 2005. She joined the FTC in 1984 as a staff attorney in the Division of Credit Practices. Harrington became Assistant Director for Marketing Practices in 1987 and served as Associate Director for Marketing Practices from 1991 to 2005.

(Parnes)

Bureau of Consumer Protection Director Parnes To Leave FTC

Federal Trade Commission Chairman William E. Kovacic announced today that Lydia B. Parnes, Director of the Bureau of Consumer Protection, will leave the agency after 27 years to enter private law practice, and that Eileen Harrington, currently BCP Deputy Director, will serve as Acting Director.

“Since the early 1980s, no one has contributed more to the FTC’s success than Lydia,” Chairman Kovacic said. “She has played a crucial role in developing and implementing programs that have made the Commission second to none among the world’s consumer protection agencies. Under her graceful and intelligent guidance, the Bureau has built and maintained a culture of excellence, dedication, innovation, and intellectual rigor.”

Parnes, who joined the agency in 1981, will join Wilson Sonsini Goodrich & Rosati in its Washington, DC office.

The Bureau of Consumer Protection enforces consumer protection laws and trade regulation rules, investigates business practices, sues law violators, develops rules to protect consumers, and provides consumer and business education. As Bureau Director, and as Deputy Director from 1992 until she became Director in 2004, Parnes helped lead many of the Bureau’s signature efforts, including the National Do Not Call Registry, the Telemarketing Sales Rule, an award-winning data security and privacy program, innovative consumer and business education, and the Consumer Sentinel, a database of consumer complaints available to more than 1,700 law enforcement organizations in the U.S., Canada, and Australia. She also helped guide an expansion of the Bureau’s financial practices and order enforcement programs, an expansion of litigation under Section 13(b) of the FTC Act, and integrated strategic planning.

Parnes joined the agency as an attorney advisor to Chairman James C. Miller III. She served as Associate Director of the Division of Marketing Practices from 1987 to 1992, and as Assistant Director of the Division of Policy and Evaluation from 1985 to 1987. Parnes is a graduate of the Washington College of Law at American University and received her undergraduate degree from American University.

Harrington has served as the Bureau’s Deputy Director since 2005. She joined the FTC in 1984 as a staff attorney in the Division of Credit Practices. Harrington became Assistant Director for Marketing Practices in 1987 and served as Associate Director for Marketing Practices from 1991 to 2005.

(Parnes)

FTC Announces Second in Series of Hearings on Evolving Intellectual Property Marketplace

The Federal Trade Commission today announced the second in a series of public hearings exploring the evolving market for intellectual property (IP). These hearings, to be held February 11 and 12, 2009 in Washington, DC, will examine remedies for patent infringement. District Court Judge Sue L. Robinson (U.S. District Court for the District of Delaware) will deliver the keynote address on the opening day.

The February 11 hearing will address patent damages, including the standards that govern such assessments, the application of these standards in court proceedings, and the impact of the resulting awards on business activity, including licensing and innovation. The hearing on February 12 will focus on permanent injunctions in the wake of the U.S. Supreme Court’s eBay decision and willful infringement. Panelists will consider, among other issues, the criteria courts have considered in deciding whether to grant or deny an injunction and the effect of these legal doctrines on innovation and business strategies. An agenda for the hearings is available on the FTC’s Web site and as a link to this press release.

These hearings are part of an ongoing series of public hearings that will examine changes in patent law, patent-related business models, and new learning about the operation of the IP marketplace since the issuance in October 2003 of the Commission report on the patent system, “To Promote Innovation: The Proper Balance of Competition and Patent Law and Policy.” The Commission held the initial hearing in the series on December 5, 2008. Additional information about the series is available at the Web site for the hearings, http://www.ftc.gov/bc/workshops/ipmarketplace/.

The Commission is seeking public comments on the remedies issues to be discussed at the February 11 and 12 hearings, and in response to any of the topics raised in the Federal Register notice announcing the hearings on the Evolving IP Marketplace. Comments must be received by February 5, 2009, and should refer to “Evolving IP Marketplace – P093900.” The Federal Register notice and information on how to submit written and electronic comments to the Commission are available at the web site for the hearings, http://www.ftc.gov/bc/workshops/ipmarketplace/.

The FTC’s hearings on the Evolving IP Marketplace are free and open to the public. Pre-registration is helpful but not required. All attendees must present a valid photo ID for admission to the agency’s Satellite building, which is located at 601 New Jersey Ave., NW. The hearings will be accessible to people with disabilities. Anyone needing a related accommodation should contact Carrie McGlothlin at the FTC at 202-326-3388 or [email protected]. Such requests should include a detailed description of the accommodations needed and contact information if more information is needed. Please provide advance notice of accommodation needs.

The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them. To file a complaint in English or Spanish, visit the FTC’s online Complaint Assistant or call 1-877-FTC-HELP (1-877-382-4357). The FTC enters complaints into Consumer Sentinel, a secure, online database available to more than 1,500 civil and criminal law enforcement agencies in the U.S. and abroad. The FTC’s Web site provides free information on a variety of consumer topics.

(IP Hearings.wpd)

Companies Turn to Advanced Therapies to Curb the Spread of Cancer

NEW YORK, Oct. 9, 2019 /PRNewswire/ — In 2019, the American Cancer Society projected 1.76 million new cancer cases diagnosed and the number of deaths to stand at 606,880 in the U.S. Overall, the alarming projection has caused concern within the biotechnology marketspace. In response, biotechnology companies, specifically companies dabbling in the immunotherapy and oncology sector, are working to develop innovative treatments and therapies in order to effectively treat patients diagnosed with cancer. Mainly, most patients suffer from lung, breast, and prostate cancer, and in 2019, the National Cancer Institute expects 268,000 new breast cancer cases, 228,150 new lung cancer cases, as well as 174,650 new prostate cancer cases. Overall, several new cancer treatments such as immunomodulators, CAR-T cell therapy, and monoclonal antibodies are also becoming more abundant as biotechnology companies further develop and market these therapies. Compared to traditional treatments, these therapies are more technologically advanced, meaning they are more effective at suppressing or possibly even eliminating cancer. However, despite the progress in technology, the demand for cancer therapies isn’t slowing down. Patients and medical institutes are constantly looking for more effective and efficient treatments in order to reduce the number of cases. And according to data compiled by Grand View Research, the global cancer immunotherapy market size is expected to reach USD 126.9 Billion by 2026 while exhibiting a CAGR of 9.6%. Additionally, the industry is expected to grow due to the increasing patient pools and higher mortality rates, while an increasing number of approvals for new immunotherapeutic drugs is also expected to propel the market. Oncology Pharma Inc. (OTC: ONPH), Kadmon Holdings, Inc. (NYSE: KDMN), Advaxis, Inc. (NASDAQ: ADXS), SELLAS Life Sciences Group, Inc. (NASDAQ: SLS), Geron Corporation (NASDAQ: GERN)

There is an ongoing shift from traditional chemotherapies to immunotherapies, which also has an impact on the market by further propelling its growth. In addition to early detection and treatment of cancer, the immuno-oncology industry is also developing post-treatment therapies to better protect patients from recurrence. There has also been an introduction of immunomodulatory drugs such as thalidomide, lenalidomide, and pomalidomide, which were among the best treatment options in the past few years. As well as an influx of newer drug classes like antibodies and HDAC inhibitors which are designed to target specific cancers. “Faced with growing clinical workloads and decreasing margins, oncologists are under a growing amount of pressure at work,” said Joe DePinto, President of Cardinal Health Specialty Solutions. “But, as our research shows, many oncologists are meeting their challenges head-on by proactively investing in tools, technology and additional clinical support staff. And today they are feeling more confident in their ability to adapt to changing trends, such as value-based care.”

Oncology Pharma Inc. (OTC: ONPH) announced yesterday that, “Stefan Gruenwald (MD, PhD), cofounder and president of Diagnomics Inc., has been elected to Oncology Pharma’s supervisory board of directors. Dr. Stefan Gruenwald is a former VP of Research and Development at Becton Dickinson, a conglomerate with a current market capitalization of approximately $68 Billion. He is the co-founder and managing partner of Genautica, established in December of 2010. Genautica is a California LLC located in close proximity to the Biotech Hub of San Diego.

Dr. Stefan Gruenwald, through Genautica, has seed-funded Diagnomics, a biotech company employing a highly qualified team of scientists, including early pioneers in sequencing the human genome. Through its investment in Diagnomics, Genautica has also been a co-founder and early investment partner of the EONE-Diagnomics Genome Center (EDGC) in Korea, which went public in 2018 on KOSDAQ, the major Korean tech stock market for over 400 Million USD. Part of the IPO proceeds have been used to buy a female health clinic (10,000 patients), build an R&D center in Songdo, Korea, housing 14 biotech and pharmaceutical companies, acquiring one of the major diagnostics distribution companies and expanding the clinical genome center approach to various countries in Asia. EDGC has grown rapidly and annual revenues for 2019 are predicted to be around 50 million USD.

Chuck Wagner, President of Oncology Pharma Inc., commented: “Oncology Pharma conducted an exhaustive search to strengthen the board of directors’ breadth of background and talent. I am delighted to have such an outstanding individual join the board to contribute to our mission, vision and goal of the company. Dr. Stefan Gruenwald is a pioneer with more than thirty years of experience in the biotechnology space and brings vast knowledge and experience in both the clinical, scientific and business fields to the company.”

“I am very excited to join the Board of Directors of Oncology Pharma,” said Dr. Gruenwald. “I’ve been involved in biotech for over a quarter of a century and I’m truly thrilled about this amazing opportunity to help this company to evolve into a world-wide leader in its space.”

ABOUT ONCOLOGY PHARMA, INC: ONCOLOGY PHARMA, INC. (OTCPK: ONPH) (the “Company”) is a pioneering oncology company dedicated to developing, manufacturing, and commercializing therapeutics. The Company has licensed Tulynode’s patent pending Autologous Immuno-therapy for durable therapy response using an extracorporeal device. The Company is currently engaging in research and development of therapeutics for oncology, and prides itself for having a world-class Advisory Board that keeps the Company in the forefront of developing technologies in cancer research, biotechnology, and healthcare.”

Kadmon Holdings, Inc. (NYSE: KDMN) presented earlier last year preclinical data on KD033, its anti-PD-L1/IL-15 fusion protein in development for oncology indications, at the Society for Immunotherapy of Cancer (SITC) Annual Meeting, taking place November 7-11, 2018, in Washington, D.C. KD033 is a novel immunotherapy designed to stimulate an immune response directed to the tumor microenvironment. Recombinant IL-15 alone, which stimulates cancer-fighting immune effector cells, is not well tolerated when administered systemically. Kadmon has developed a novel approach to overcome this challenge by fusing IL-15 to an anti-PD-L1 antibody to direct IL-15 activity specifically to the tumor microenvironment, promoting efficacy and inducing durable responses while potentially increasing tolerability. “Although immunotherapy has been game-changing for the treatment of cancer, many tumors learn to evade current therapies, limiting efficacy and durability of response. New approaches are needed to address relapsed or refractory patients as well as non-responders,” said Harlan W. Waksal, M.D., President and CEO at Kadmon. “By directing a potent cancer-fighting response to the tumor site, KD033 has potential to safely overcome resistance and induce long-lasting responses for patients. We look forward to continuing our research on KD033 and initiating our first-in-patient studies in the second half of 2019.”

Advaxis, Inc. (NASDAQ: ADXS) a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, announced recently updated data from the Phase 1/2 KEYNOTE-046 study in metastatic, castration-resistant prostate cancer (mCRPC). This trial is being conducted in conjunction with Merck (known as MSD outside the U.S. and Canada) and is evaluating ADXS-PSA, one of Advaxis’ Listeria monocytogenes (Lm)-based immunotherapies, alone and in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy. Findings will be highlighted in a poster discussion entitled “Effects of ADXS-PSA with or without Pembrolizumab on Survival and Antigen Spreading in Metastatic, Castration-Resistant Prostate Cancer Patients” at the American Association for Cancer Research (AACR) Annual Meeting underway in Atlanta. The poster discussion will be held today from 1:00-5:00 p.m. ET and will be led by lead author Mark N. Stein M.D., FACS, Associate Professor of Medical Oncology at Columbia University Medical Center. “We are very excited to report the updated ADXS-PSA data today at the AACR meeting,” said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. “These data show the clinical potential of ADXS-PSA both alone and in combination with KEYTRUDA®. It is meaningful that the combination has been well-tolerated in the study population because dose-related toxicities can present challenges for cancer patients, and an additive therapy with a favorable safety and tolerability profile may offer an attractive option for clinicians if developed further in this indication.” He concluded, “Based on the prolonged survival data and strong safety profile to date, we believe that continued clinical development of ADXS-PSA in combination with KEYTRUDA® is warranted and represents a potentially significant opportunity for Advaxis.”

SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) is a clinical-stage biopharmaceutical company focused on novel cancer immunotherapeutics for a broad range of cancer indications. SELLAS Life Sciences Group, Inc. recently announced the dosing of the first patient in its Phase 1/2 open-label study of GPS in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab), in patients with selected WT1-positive advanced cancers, including both solid tumors and hematologic malignances. “This is an important milestone as this study allows us to potentially enhance our safety and activity profile of GPS in combination with anti-PD-1 therapies, particularly in combination with KEYTRUDA® in multiple malignances, following intriguing initial combination clinical data with OPDIVO®,” said Angelos M. Stergiou, M.D., ScD h.c., President and Chief Executive Officer of SELLAS. “We are confident this study will build on our body of clinical evidence in support of the use of GPS in combination with PD-1 inhibitors to benefit cancer patients with limited treatment options. We believe that our innovative WT1 immunotherapeutic, GPS, in combination with anti-PD-1 immunotherapy agents, may provide therapeutic benefit for patients with WT1 expression. These beliefs are shared by the renowned U.S. oncologists who are undertaking this work. We look forward to studying this combination in patients with a wide range of cancers and expect to provide the first clinical data from this study in the first quarter of 2020.”

Geron Corporation (NASDAQ: GERN) is a late-stage clinical biopharmaceutical company focused on the development and potential commercialization of a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. Geron Corporation recently announced the opening of patient screening and enrollment for the Phase 3 portion of IMerge to evaluate imetelstat, a first-in-class telomerase inhibitor, in lower risk myelodysplastic syndromes (MDS). IMerge is a two-part Phase 2/3 clinical trial of imetelstat in transfusion dependent patients with lower risk MDS who are relapsed after or refractory to erythroid stimulating agents (ESAs). The Phase 3 portion is planned to enroll approximately 170 patients in a randomized, double-blind, placebo-controlled clinical trial to test the hypothesis that imetelstat improves the rate of red blood cell transfusion independence (TI). The trial is planned to be conducted at multiple medical centers globally, including North America, Europe, Middle East and Asia. The primary efficacy endpoint is 8-week TI rate, which is defined as the proportion of patients achieving transfusion independence during any consecutive eight weeks since entry into the trial. Key secondary endpoints include the rate of transfusion independence lasting at least 24 weeks, or 24-week TI rate, durability of transfusion independence and the amount and relative change in transfusions. “The start of the Phase 3 portion of IMerge is a significant milestone for Geron and imetelstat,” said John A. Scarlett, M.D., Chairman and Chief Executive Officer. “We are hopeful that the Phase 3 will confirm the encouraging results from the Phase 2 portion, and that imetelstat could become a much-needed treatment alternative for patients with lower risk MDS.”

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