The simple fact that most approvals requires 2 x P3 trials the second of which is called confirmatory and that it is very rare to see an OLE study taking the place of confirmatory trial.
Anavex to date have not run a single clinical trial labelled a P3 trial designed and of an appropriate size and duration. Instead the company have run P2 maybe P3 too small trials, none of which have had successful topline outcomes.
But as a biotech investor of course you already know that.
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