Starting to think no news today would be betterTrying to decipher FDA process. I believe Cheetio is correct in stating that if there is a problem with the application they will notify on day 60 as what would the point be to Mae you wait if there is a problem with the application. Second point is that the 74 day letter will Adidas you if your application has been approved with no mistakes and either standard review or accelerated review. I believe standard review has to be completed within 180 days of approval of BLA submission. Accelerated I suspect is as fast as they can. This is my interpretation of the NR and the FDA website. I also read that the submission is usually 100 thousand pages on average. Nice read
not sure how to take a halt today. Either poop my pants or drink more or both.
Cheers
JASL