News Focus
News Focus
icon url

jq1234

05/13/14 7:57 PM

#11824 RE: pollyvonwog #11823

I don't think it would affect eventual approval, delay is certainly possible because FDA ultimately has to address some not all of the points Teva raised in eventual approval document.
icon url

biotech_researcher

05/13/14 7:58 PM

#11825 RE: pollyvonwog #11823

This is stunningly complex. Seems to me that if the worst case scenario is a 2015 approval at a 75% possibility, then this is a tolerable risk at this point.