Biotech Valuation Message Board

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

CRSP 55.98

-0.8%

9:37 AM EST

Public Reply Prvt Reply Mark as Last Read File

Previous 10 Next 10 Previous Next

To: jayhawk969 who wrote (10537)	2/20/2004 2:49:57 PM
From: Biomaven	Read Replies (1) 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

Report TOU Violation

Share This Post

Public Reply Prvt Reply Mark as Last Read File

Previous 10 Next 10 Previous Next