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Biotech / Medical : Biotech Valuation

CRSP 55.11

-2.6%

Nov 7 9:30 AM EST

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To: Biomaven who wrote (7557)	12/22/2002 6:10:42 AM
From: Icebrg	Read Replies (1) of 52153

Peter >> SEPR - this wasn't a delay. The issue here was some questions on the preclinical data in the bridging package they licensed from RPR in Europe from when the original drug was first approved there. SEPR wanted to make sure the FDA was OK with their re-do of some of the data before they filed. SEPR, in their new ultra-cautious mode had sent out lots of signals that they didn't know what the FDA would say about the new data. Hence when the FDA gave a nod, everyone breathed a considerable sigh of relief.>> I don't want to dispute that the long-term holders of Sepracor may have a reason to indulge in the luxury of a relief-sigh. Over the last year the situation has felt rather tense and there has been far too few sighs released. At least of this type. However, as for the question of the timing, I still tend to believe, that there actually was (or is) a further delay. As late as at the SG Cowen conference in November, Sepracor said that they would be filing the NDA in H2:2002. At that time they should have had a pretty good overview of the status of the preparation of the filing package. So, when they now say mid-February something has changed. It is in my experience not very common that companies pre-announce IND-dates in this way. In most cases they seem to want to say nothing even after they have filed, if they can get away with it. The fact that they even went as far as issuing a PR to announce the future filing seems to indicate, that they wanted to tell us that although they were not able to live up to the timetable given earlier, this is still not a lost cause. Erik

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