Your explanations are at a disconnect from the EMA stats. You decided -- you and not the EMA -- that the Anavex trial fails to support the likelihood of an EMA approval without a second Phase 3. If that were close to being true, then why didn't the EMA give Anavex a conditional approval to submit (i.e., with the need for a confirming trial)?
The time for individuals to submit their arguments on the merits of the 2b/3 was superseded as best evidence the moment CHMP gave the company the go-ahead to submit an MAA. The relevant inquiry has now moved on to examining the EMA's future decision making in light of their action. You are still living in the past with your personal analysis.
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