Genta Incorporated
OTC : GETA

April 08, 2010 08:30 ET

Genta Poised For A Rebound Year Based On Latest Company Developments

TORONTO, ONTARIO--(Marketwire - April 8, 2010) - TheMarketFinancial.com, the news portal which covers the latest Wall Street developments while delivering financial and investment intelligence to a community of highly informed investors, has issued a special independent research coverage on Genta Incorporated (OTC:GETA).

The latest development for Genta came with their flagship product, Tesetaxel, being granted Fast Track designation by the FDA for advanced gastric cancer, a more profound medical term for stomach cancer. This news comes in light of some very important turn of events for the gastric cancer drug market, as it is projected to double to nearly $1.5 billion in 2018.

According to a recent report published on News-Medical.net, "Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and health care issues, finds that the gastric cancer drug market — driven by the launch of several targeted agents over the next few years — will more than double from approximately $700 million in 2008 to nearly $1.5 billion in 2018 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan."

Many investors don't understand the importance of a Fast Track designation, and its purpose in aligning the drug towards commercial success. Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.

A drug that receives Fast Track designation is eligible for some or all of the following:

  • More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
  • More frequent written correspondence from FDA about such things as the design of the proposed clinical trials
  • Eligibility for Accelerated Approval, i.e., approval on an effect on a surrogate, or substitute endpoint reasonably likely to predict clinical benefit
  • Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA, and
  • Dispute resolution if the drug company is not satisfied with an FDA decision not to grant Fast Track status.

Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.

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