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 : Neurex Corporation
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  
To: Jeffers Hughes who wrote (344)9/14/1997 2:23:00 PM
From: NeuroInvestment   of 449
 
The original NDA was accepted by the FDA in 6/96. There has been a 3month extension already on the 1 year framework allowed by User Fee Legislation. The FDA always has room to maneuver, requesting further extensions, but the last time I spoke with NXCO management, they stated that they firmly expected approval by the end of this month, which would be the next User Fee deadline. If this does not occur, it would be worrisome, because that would indicate that the negotiations around labeling (vis-a-vis beta blockers, renal effects, etc) have hit a serious snag. Thus far I have heard nothing to indicate this, and I am expecting approval by the end of September. NeuroInvestment
Report TOU ViolationShare This Post
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  

HomeMailHotSubjectMarksPeopleMarksKeepersSettings
Terms Of UseContact UsCopyright/IP PolicyPrivacy PolicyAbout UsFAQAdvertise on SI
© 2026 Knight Sac Media.  Data provided by Twelve Data, Alpha Vantage, and CityFALCON News