To: bio_kruncher who wrote (10530 ) 2/20/2004 11:47:31 AM From: Icebrg Read Replies (2) | Respond to of 52153 Sepracor I believe the first pre-goalpost moving part of my answer was left behind. So, just to demonstrate that I sort of understand that the percentages should add up to 100, here is the rest - i.e. the original part of my post. [Slightly edited to make myself clearer]. ErikAs far as I know, Sepracor recently said that they have not yet started the labelling discussions. So, I don't think there will be any approval. This seems also to be the message between the lines. When the labelling has been "agreed" upon, it will be for a relatively short period. The reason they are now conducting a second 6 month study is to support such a label extension. I don't think it is very likely that we will see a non-approvable outcome either. If there were doubt about the product they should at least have brought the matter to an advisory committee meeting. They have not, which means that they have basically made up their mind to approve. As for the no decision alternative. Well, they have already had 15 months for thinking. I don't believe they will ask for even more. My percentages. 1. Approval with short term label. 5% 2. Approval with long term label 0% 3. Approvable 95 % 4. Not approvable 0% 5. No decision 0% As for the price - the approval is already in there. And with Indiplon and the Ambien and Sonata XRs in the wings, I don't see any immediate and major price movements. 2 dollars perhaps for an approval and nothing for approvable only. But from where will these changes take place? I believe that there will be a certain share price appreciation going into the day of the PDUFA. So, my guess is that we will see 30 dollars before the decision as well as after the event. Unless there is a short-label approval. Then the price may go up to 32 - as no-one really is expecting an approval already, there will not be so much selling on the news.