I hope that Anavex is applying for one of the five slots for the new very rapid approval program. Getting one of those slots would definitely get FDA approval before the EU.
Well maybe they have a good chance since they already have pullled all the material together for the EMA. Just need to tweak it for the FDA
Anavex is applying for one of the five slots for the new very rapid approval program.
When the purpose of the program is to show rapid progess of new drugs, and the FDA will want to showcase any approvals, seems like you would pick the company who: 1. Already did a filing for the drug so it has all its ducks lined up to go. 2. Has a drug with a large, critical unmet need like alz. 3. Is super safe, so you don't end up approving s drug that kills people and leads to criticism of the program.