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 : ARIAD Pharmaceuticals
ARIA 23.990.0%Feb 17 4:00 PM EST
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  
To: GregorioAllegri who wrote (2937)11/4/2013 10:01:32 AM
From: jq1234si  Read Replies (1) of 4474
 
For NDA review, FDA analyzes ALL data submitted by the sponsors in NDA only. Vital signs data are part of pretty much of ALL NDA submission. FDA doesn't go collecting their own data, unlike post marketing data.

You asked the right question about ph1 data. What prompted me to read FDA review doc in the first place was the difference between ARIA's AE data presentation at ASH2012 and FDA approved label a few days later.

Here is link to FDA review:

accessdata.fda.gov
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