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

To: Icebrg who wrote (7588)	12/22/2002 11:55:30 AM
From: Biomaven	Respond to of 52153

Ice, <SEPR> So, when they now say mid-February something has changed. Well they only had their pre-NDA meeting with the FDA this month, and I wouldn't be surprised if the FDA had made some suggestions on presentation issues. not very common that companies pre-announce IND-dates in this way. Well this was a somewhat exceptional situation. SEPR knew there was a potential issue with the NDA, and didn't want to blindside the investment community again. Thus we were in the loop much more than would normally be the case. The fact that after their FDA meeting they have given us a definite close target date means to my mind that the FDA was basically OK with this issue. Given you are having a pre-submission meeting with the FDA, any NDA target date you give prior to that meeting has of necessity to be tentative. I don't care about a month or two slippage - I do care about the FDA saying go away and do more studies. Peter