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Biotech / Medical : Incyte (INCY)
INCY 59.94+0.8%Jun 12 4:00 PM EDT

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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.
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