|<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.