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To: toccodolce who wrote (4033)	4/6/2000 6:30:00 AM
From: Tom Drolet	Read Replies (1) \| Respond to of 14101

Tom: The link worked--neat general review article. Thxs Tom D.

To: toccodolce who wrote (4033)	4/6/2000 1:18:00 PM
From: Montana Wildhack	Read Replies (1) \| Respond to of 14101

Hi Thomas, Welcome. That was a great overview. I saw that going into phase 3 meant roughly a 60% probability of getting FDA approval. Wolf

To: toccodolce who wrote (4033)	4/6/2000 10:34:00 PM
From: Tapcon	Respond to of 14101

Timeline review? Has Phase 3 been completed and FDA approval sought? Sounded from the article that after completing phase 3, the AVERAGE wait for FDA approval is 18-24 months (and that approval success rate coming out of Phase 3 is 70%). Where are we at? REFERENCE: Assuming the drug reaches the desirable end point in Phase 3 trials, the company will then file a New Drug Application, which can contain 100,000 pages of data supporting the efficacy and safety of the drug. At this point, the drug has better than a 70% chance of being approved by the FDA. Approval of the NDA can take anywhere from two months to an extreme of several years (in the case that the FDA requests additional information), with an average wait of between 18 and 24 months. Upon approval, the company may begin to market and distribute the drug.