anonymous
Guest
anonymous
Guest
Another moron typing at a computer that has no clue what they are talking about. The FDA DID NOT reject Amx035. That occurs at the PDUFA meeting. The meeting Wednesday was an advisory committee meeting. They do not approve or disapprove drugs, they make recommendations. The vote was 6-4 in favor of not approving, which will be taken into consideration at the PDUFA meeting on June 29th. While it does not look good for the drug, it can still be approved on the 29th. There will be tons of pressure for approval, I would say it's 60-40 against approval, but to be very clear, THE DRUG DID NOT GET REJECTED. How do you even have a job in this industry without understanding simple procedures?
preach, sista