Can I remind everyone that we are still at Day 0 in the EMA process awaiting Anavex actually filing the MAA and having it validated for completeness. Only then starts the CHMP review process that includes 2 Company Clock-stops to address any and all CHMP feedback.
We have some way to go yet! I did however acknowledge there is a chance of approval in the post you replied to.
For the avoidance of doubt I do not apply the Bio calculation to that chance, but I will be even more encourage once Anavex files the MAA and have it validated - who knows when...
Somehow, the EMA [the European Medicines Agency, the drug approval agency for the European Union] has found the P2b/3 trial data pivotal and recommend Anavex file for approval.
From the accumulated knowledge posted on this message board, for some time, real drug experts have told us all of the deficiencies of the Anavex drug candidates, their poorly conducted clinical trials, the company itself, and particularly the company’s bungling CEO. For those in the know, there’s nothing good that can happen with the Anavex drug candidates other than to be discarded.
But how deluded, then, must be the offish EMA. Of all things, they have actually encouraged Anavex to file for approval of blarcamesine in Europe. They’ve apparently failed to see through the cleverly worded documents of Anavex. They’ve failed to understand that the clinical trials of the drugs were really well-disguised failures. Nobody got better; lots of side effects; and not enough patients to be statistically sure of anything. Apparently, the “physicians” and “scientists” on the EMA review board never took (or passed) a college biostatistics class. They are thinking that the P-values they saw in the clinical data Anavex provided are the “Ponder-factors,” which they thought were good.
Me, I now know better. I need to follow the experts on this message board. At this moment, the AVXL share price is $9.28. I’d better get in my sell order, as I have an on-paper (well, spreadsheet) gain of exactly 100.57%, a bit more than 2x what I paid for my shares. I’d better take my profits while there’s still time. Some folks at the EMA might soon learn the truth and retract any invitations they sent to Anavex. Game over, then.