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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (6978)	8/24/2002 3:43:04 PM
From: jayhawk969	Respond to of 52153

This is what I was referring to. Aug. 1 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc., (Nasdaq: NTII - News) NTI® today announced that Forest Laboratories (NYSE: FRX - News) has submitted an NDA (New Drug Application) to the Food and Drug Administration (FDA) to market Memantine for the treatment of moderate to severe Alzheimer's disease. If approved by the FDA, Memantine would be the first drug on the market for moderate to severe Alzheimer's patients. Memantine is an NMDA-antagonist that modulates the flow of calcium to the brain. Mr. Paul Freiman, President and Chief Executive Officer said, "The filing of the NDA by Forest in the United States clearly validates the importance of Memantine as a new class of drugs which, subject to FDA approval, will be valuable in treating this debilitating disease in the segment of Alzheimer's patients that up until now has had very few options. We are encouraged by this filing, especially on the heels of the drug's recent approval in Europe and the prospective marketing of Memantine in Europe over the near future." Upon submission of the NDA, the FDA has a period of 60 days to determine if it will be accepted for filing and review by an advisory panel. The filing included two pivotal trials, one in the U.S. and one in Europe. There is a possibility that the FDA might not accept the filing due to the fact that the trial conducted in Europe did not include an endpoint that the agency has historically required in evaluating treatments for the mild-to-moderate Alzheimer's patients. Currently, NTI's collaborator, Forest Laboratories, is conducting four additional placebo-controlled studies in either mild-to-moderate or moderate-to-severe Alzheimer's disease. The results are expected no earlier than 2003..... siliconinvestor.com