Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

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

To: jayhawk969 who wrote (10537)	2/20/2004 2:49:57 PM
From: Biomaven	Read Replies (1) \| Respond to of 52153

<Estorra> The issue as I recall it was that there was a carcinogenicity signal in animal studies in the original RPR zopiclone package. So SEPR re-did the study (using ezopiclone and current standards) and have repeatedly stated that they saw no such signal in the new study. This was the study that was submitted close to the original PDUFA date and which the FDA asked to be reformatted. (SEPR's explanation at the time was that the overall tox package was thus about twice the size of normal, and so needing more time to analyze and reconcile was reasonable). So this issue isn't of that much concern to me (I didn't go and listen to the call again). The FDA and SEPR may still fight about whether the label should include the original signal or not. Peter

To: jayhawk969 who wrote (10537)	2/20/2004 5:40:57 PM
From: fred hayes	Respond to of 52153

JD:(Estorra approval) >This is my single biggest concern regarding this filing< I went back and listened again. I understood that it was additional data analysis that confirmed there were no carcinogenic signals. It didn't sound like a precaution, it sounded like a reassurance. Seems like, if that's true, it would be surprising (to me anyway) for FDA to find some signals when SEPR did not. fred

To: jayhawk969 who wrote (10537)	2/20/2004 6:07:11 PM
From: quidditch	Read Replies (3) \| Respond to of 52153

J.D., I did go back and listen to that part of the call and related Q&A (while doing a few other things), and I come out closer to your perspective (which, unabetted by Peter's expertise, doesn't mean a whole heck of a lot) than to Peter's or Fred's. In the presentation part of the call, Corrigan somewhat stressed that it was "our opinion" that the new studies didn't confirm any tox signal or indicate other tox issues. In the Q&A, I thought that he got very mealy mouthed about trying to clarify what the parameters and premises of that opinion are. There is no question that SEPR knew that this would come up in the call; presumably, the answer was thought out and vetted by counsel. There is also no question that management didn't want to go out on a limb with false negatives. That said, I thought that the answer management gave in the Q&A lacked clarity and forthrightness. Isn't it better to give the facts than a murky characterization of the facts? quid