re:"Why hasn't fda given accelerated approval or breakthrough designation if the there is proof from clinical studies that 2-73 works better than the soc? "
Looked at pr's for 2016 and 2015 I notice that they didn't pr applying for each Orphan Drug Designation. They did PR when they got it. Looks like for 3 different indications. Ne'er do well OTC's will pump their stock by announcing the application but then that's as far as it gets. Here, by granting the designations the FDA acknowledges the work done proving efficacy so far and OK for further human trial. Also, the FDA can withdraw the designation at any time. They haven't done so.
Orphan drug status has some real benefits. Besides years of exclusivity they also get to deduct 50% of their R&D expense from their future tax bill.
Accelerated approval, breakthrough, and fast track are all pretty similar. I was looking at "fast track". It's not very fast, the FDA will get back with you in 60 days after you apply. Then you still have to go through the required trials but get to submit partial paperwork instead of all at once at the end. It may reduce approval time from 10 months to as little as 6 months. Apart from some bragging rights, not that great.
So far as I can tell, Anavex meets the criteria. Since they didn't make a big deal about applying for Orphan, we don't know that they didn't apply for one of these.
Or they may have taken a pass. The adaptive trial design they worked out with the FDA seems to offer the same benefits, may actually be better.
