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 : Regeneron Pharmaceuticals
REGN 766.82+1.5%3:34 PM EST
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  
To: Felix B who wrote (1959)10/30/2016 12:14:57 PM
From: Miljenko Zuanic   of 3559
 
There in no time frame definition for delay after CRL. It can be few months, it can be permanently. Usually it take 3 month to respond (and resolve) to FDA manufacturing (CMC) concerns. Unless problems are much deeper and need more time (corrective action plans + completed tasks before FDA will do re-inspection). In that case they will need 6-12 months. Very DISTURBING events in Sanofi collaboration, for sure.
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