Post by
Jasl on Aug 28, 2015 8:22am
Starting to think no news today would be better
Trying 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
Comment by
investderp on Aug 28, 2015 8:33am
6 months (180 days) for priority review; 10 months for standard review.
Comment by
Jasl on Aug 28, 2015 8:39am
Cheers Thanks investderp drinking couvassier in coffee since 4 am. And reading a lot of rules and regs. Hope 6 months with approval. JASL
Comment by
princeofcut on Aug 28, 2015 9:30am
peon, more TST bagholder idiocy..wasn't that from 2005 or 2006...the time to have moved on it was back when the PIII ended and gotta ask what incompetence kept them from doing so back then???..it should either get rejected or priority review based on its submission and the fact it is a cancer drug (life saving)
Comment by
Tson99 on Aug 28, 2015 10:10am
Who cares when it was from? The fact is that the FDA has already approved MCNA for fast track (priority) review. Whether or not the BLA is complete is the question. Thanks for the name calling though...I appreciate that.
Comment by
princeofcut on Aug 28, 2015 10:21am
..peon, ROTFLMAO...isnt the rolling review aspect of fast track extermely important, or likely you didnt know that...and so like i said that book is closed...you TST bagholders deserve whatever i post to you, do anyone of you know anything of value regarding this stock
Comment by
Tson99 on Aug 28, 2015 10:56am
Whatever "Piece of Sh!t" .....do you get a nickel or quarter for a direct response? Better put it in you pocket...that is the last one you will get from me. Cheers,
Comment by
cheetio on Aug 28, 2015 8:43am
fda,,,,,,,,,,The RPM notifies the applicant of a priority review designation in writing by day-60, or of a standard review by day-74 (in the Filing Communication). .......right saviour