Post by babaoriley on Apr 7, 2014 19:09:29 GMT -5
I'm sure the FDA loves to have investors tell them what they think! I would take Matt at his word, especially if you're out right now, Stevie.
Here's what I would like to know from MNKD: (1) are there any outstanding requests for info from the FDA at this point;
(2) was the last batch of information sent to the FDA in time such that whatever that information was, it could reasonably be presumed to have been included in the review by the staff, and thus analysis of same included in the Briefing Document.
Hopefully, the answers are "no" and "yes." If either answer is not "no" then "yes," then I'd love to know if the information requested could reasonably be interpreted as a "major amendment" to the NDA.
Here's what I would like to know from MNKD: (1) are there any outstanding requests for info from the FDA at this point;
(2) was the last batch of information sent to the FDA in time such that whatever that information was, it could reasonably be presumed to have been included in the review by the staff, and thus analysis of same included in the Briefing Document.
Hopefully, the answers are "no" and "yes." If either answer is not "no" then "yes," then I'd love to know if the information requested could reasonably be interpreted as a "major amendment" to the NDA.