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Politics : Formerly About Applied Materials -- Ignore unavailable to you. Want to Upgrade?


To: Sam Citron who wrote (62524)3/29/2002 7:39:37 PM
From: kdavy  Read Replies (2) | Respond to of 70976
 
Sam: I can answer that for you. Go to FDA site, www.FDA.gov, go to CDER for Chemical entities (small molecules) or CBER for biologicals (recombinant proteins, vaccines, blood products etc.) You can get last 6 or 7 years of drugs approved.

The answer to the second part is "No". There is no way of knowing in advance if letter will be approvable or not. For the "NDA" new drug application (final approval) there are two steps; first a review panel makes its recommendation and then some time later the the review committee meets and make a final decision. In most cases the committee follows the panel recommendations but there have been cases where the committee has turned down the panel recommendations. The success rate at the NDA level is pretty good roughly 40 to 50%( guessing). Most of the drug candidates drop out in the preclinical stage, or in Phase I, II or III stages. Check out the drugs in pipeline. If there are many then chances are that at least some of them will make it.

Good luck.

kdavy
PS: only thing I am holding is 1000 shares of amat with cover calls strike price 50 and sold puts strike price at 45