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Biotech / Medical : Biotech vs. Shorts

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To: Vector1 who wrote (189)	8/27/1999 3:02:00 PM
From: RWReeves	Read Replies (2) of 427

Interesting analysis. You could take it further and actually value the options based on projected outcomes and probabilities. Rejection of a filing is FDA's way of saying "don't waste our time" and is generally reserved for the work product of real loser regulatory people. It's a real spanking, and a wake up call. If you survive it (the CEO won't be very happy for a while) I'd imagine next time you get it right. IMO not a big risk here. But accepting it just means "it looks OK from a cursory review" and you can still get lots of questions from the reviewers. We've recently worked with two on the MAb side, one very experienced who resolved things very quickly based on good answers and a new one who was asking a lot of questions about very basic stuff- getting an education courtesy of the manufacturer, as it commonly turns out. Remember the FDA hires lots of new people, usually academics, all the time. Get one and you pay the price. IMO 50/50 chance- the market doesn't see the behind the scenes action and no penalty unless you get in a fight or it drags on for months years. BRMAC or the Biologicals Response Modifiers Advisory Committee can recommend but final approval is up to the agency which can go with or against the recommendations (COR is a good example where the agency decided yes, AC said no). Problem is even GREAT data presented badly can earn you a mixed review- AC-yes FDA-no. THAT would do the "drop like a rock" act for these guys. The composition of BRMAC is public knowledge- as are all their transcripts and you can review who likes/hates what. Finally, consider the position of CBER. What do they WANT to happen and what are their CONCERNS? The agency and CBER are not shy about telegraphing their feelings and ideas (FDA has feelings?) if you pay attention. If you combine the answers to A+B+C+D+E you get the net result of the FDA lotto for just plain old vanilla long/short decisions. I'm long CLTR based on the above subject to closer DD of CLTR's RA people. RWR

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