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.  For example, here is how to disable FireFox ad content blocking while on Silicon Investor.
Biotech / Medical : Incyte (INCY)
INCY 92.81-2.2%Dec 12 3:59 PM EST

 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  
To: scaram(o)uche who wrote (3177)4/24/2018 12:30:53 PM
From: Miljenko Zuanic  Read Replies (2) of 3202
 
<How could any FDA be more liberal than the Gottlieb FDA?>

They (reviewers) had a chance to change how they should review revised application, but they did not. They kept old (from CRL) format focusing on 4 mg safety, not overall modality of approval, that LLY asked. 2 mg for overall population, refractory/failed methox, and bumping to 4mg for those who need MORE. FDA had a chance to dictate scope of discussion, but they did not!

That is my problem with FDA. I do not favor/disfavor with their decision, but how they come to conclusion is "problematic"!

I own INCY (after 301 fiasko, believe that Epa is not dead), and Bidi does not make thing any easy.
Report TOU ViolationShare This Post
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext