SI
SI
discoversearch

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 : CEPH
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  
To: Brian Pastor who wrote (480)11/4/1997 6:39:00 PM
From: bysfbay  Read Replies (2) of 998
 
> This is simply the end of the 90 day extension the FDA announced on
> August 11, 1997. So it appears the money is heavily betting on
> approval.

Over two months ago, an FDA advisory board recommended (to the FDA approval board by majority vote) not to give CEPH approval of Myotrophin. Cited was inconclusive results from a European study where the non-control group had an elevated number of deaths over the control group. Between then and now, what would've changed other than continued good response by patients using this drug? Is this sufficient to warrant NDA approval?
Report TOU ViolationShare This Post
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  

HomeMailHotSubjectMarksPeopleMarksKeepersSettings
Terms Of UseContact UsCopyright/IP PolicyPrivacy PolicyAbout UsFAQAdvertise on SI
© 2025 Knight Sac Media.  Data provided by Twelve Data, Alpha Vantage, and CityFALCON News