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.
Pastimes : Clown-Free Zone... sorry, no clowns allowed
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  
To: Terry Maloney who wrote (232638)4/1/2003 10:33:56 AM
From: reaper  Read Replies (1) of 436258
 
terry i think this guy is a little off in his expectations.

they filed the Estora NDA on 3 Feb. what is coming up is notice of acceptance of the NDA (i.e. that the filing is sufficient, data in good form, etc), not the ruling on the drug. i can think of no good reason for the FDA to reject the NDA submission, though it certainly could happen. rejection of the NDA would be a large downside event, although acceptance is just normal course of business. the FDA will likely review Estora on a 10-month timeline, which would mean the decision date is in December 2003. fwiw this isn't expected to be a huge drug (maybe $300-400mm peak sales).

Cheers
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