This is such a bizarre forum sometimes. The standard has always been 2 P3 trials. OLE trials nearly ALWAYS follow from P3 trials regardless. Every other company seeking approval for AD indication has run TWO large P3 trials (and OLEs.) It is not even debatable (although some are trying to make it a debate) that Anavex has failed to run another large confirmatory trial. OLEs don't count. So, just stop with the nonsense.
What we are banking on is the EMA not holding Anavex to the same standard it holds other companies to. We all think that the data is good enough to give the EMA a basis to approve despite the massive shortcomings of the application: the efficacy and safety, we hope, outweigh the bizarre decision not to run a 2nd P3. There is a good chance approval will happen because they haven't withdrawn the application and, so far, they are in lockstep with their whole cohort of MAAs that were submitted at the same time.
But, let's not pretend that they didn't file with the FDA out of preference. The FDA would not allow the application, IMO, because they need the confirmatory trial. Maybe the EMA approval changes the calculus - and that is definitely what Missling is gambling on and what we are also hoping for. Had management simply done what any other management team with a new and better molecule for a huge, unmet need would have done then all the risk would be gone: this would be a no-brainer, definitely a full MA, and a pending market cap of $15b. As it is, we sit at $750m market cap and hope and pray the goddess of luck smiles on us.
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