Anavex Life Sciences Corp (AVXL)

[Gator328]

The drug itself may be far superior. But I'm not naive enough to believe that the FDA doesn't occasionally buckle to political and outside pressures, otherwise Biogen's drug wouldn't have even made it to the AdComm stage of the review process let alone being granted approval.

The FDA will eventually have to approve Aducanumab's replacement but there's no guarantee that Anavex will be first in line. Breakthrough designation would be nice but its far from guaranteed now that there is a recently approved drug on the market -- one that Biogen is willing to spend hundreds of millions to keep on the market for as long as possible.

Assuming Anavex gets the priority review voucher, it then has a 90% chance of having a decision within 6 months (the voucher doesn't promise immediate review, only that the FDA will try its hardest to do so). To me, that is far more valuable than $100 million or whatever they are going for these days. If AVXL does get breakthrough designation, it can always use the voucher to advance A371.

If you were Dr. Missling and just received a rare pediatric disease priority voucher, how would you use it?