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

To: Sam Citron who wrote (5819)	3/7/2002 9:30:21 PM
From: Ian@SI	Respond to of 52153

Keep thinking like that Sam and we'll start a write-in campaign to convince Bush to nominate you to lead the FDA. :^)

To: Sam Citron who wrote (5819)	3/7/2002 10:57:34 PM
From: Zeev Hed	Read Replies (1) \| Respond to of 52153

My experience is more with instrumentation rather then drugs, but the FDA will work with the applying company and pre approve a testing protocol for the PMA (or for that matter even 510K) process. I presume the same is true with NDA's. As for SEPR, I think that the market reaction is more reflection on management being "caught flat footed", thinking they did what was necessary, but apparently not crossing all the "t"'s. With a drug to treat allergies, I would expect that very long term regimen would be anticipated, and I have no idea how does the applicant respond to questions of long term impact, except showing that the active ingredients and their metabolites are completely "extracted" after a given and relatively short period, and that side effects are not cumulative. Zeev