questions on fda fast track, accelerated approval, and priority review
when i read the sections at the fda web site fast tracking seemed to fit us in that we have a superior drug no safety issues and a devastating disease. when i read the priority review they have actually did not always take 6 months to review. on some drugs aids ,cancer they did it in two to four months. the regular review is up to ten months. these boys do not have time on their side . if you are interested put in fda and the three processes i mentioned good read. which is the fastest? im not actually sure. it depends on your strategy and how friendly the fda is to you.
in the usual process the fda can pull the drug during aa i do not believe this will be the case with our drug. but if there were bad side effects they can do this in the process with any drug they are monitoring
Your question implies they are mutually exclusive - to the contrary, a drug can qualify for all three. Eteplirsen already has fast track status and given its profile should qualify for accelerated approval and priority review.
no, i didnt say they are exclusive. what i am wandering is can they be by themselves or do you have to have two of the three or all three. the fda will monitor you if you get aa and your drug can be pulled from usage if it fails to provide useful end points of treatment. but we can charge insurance and earn money in aa, and will receive full approval later after we satisfy the fdas process. also is one way quicker than the others. i do not believe it will take 6 months for aa, based on what i read.