Breaking News and Insider Scoops April 8, 2010
Genta Has Released Major Updates On It`s Flaship Product Market
Gastric Market Projected To Double To 1.5 Billion
Dear Traders,
Please read the latest press release from Genta.
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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