Anavex Life Sciences Corp (AVXL)

[Investor2014]

Yes a correct sentence as such.

A P3 is NOT required after AA only a P4 study to run concurrently with commercial sales.

Except not as applied to the present Anavex scenario!

As for example was the case with the Lequembi AA that will gain traditional approval based on the P3 trial that was already completed when AA was granted. AA without a P4!!!

Further, as we can understand from here: Association Between Preapproval Confirmatory Trial Initiation and Conversion to Traditional Approval or Withdrawal in the FDA Accelerated Approval Pathway. A strategy that initiates a P3 trial before AA allowed Lequembi to be on the market for commercial sales out of a P2(b) trial data enabled by a surrogate biomarker response and a parallel running P3 confirmatory trial initiated earlier (which also had preliminary data available by the time of AA).

Anavex, according to their plan, will be initiating a confirmatory trial in parallel with regulatory discussions about AA pathways. If Anavex do achieve AA, there will then already be a P3 trial running that may later be the basis for traditional approval and no P4 trial required. Just like the lequembi scenario, although the completion of that Anavex AD P3 confirmatory trial will be 2 - 3 years after a potential AA decision. Obviously, in that scenario if granted AA, the company will not also on top have to run another confirmatory P4 trial.

If AA is not granted, well then Anavex have P3 Precision Medicine trial selecting for enrollment on best responder criterion already well underway. This confirmatory trial could then lead to traditional approval also without the need for a P4 trial.

You see, adding 2+2 doesn't after all always make (P) 4.

The resistance here to this optimised two shots at AD approval strategy, I find really quite odd! It in imo is the smartest move Anavex could make. The timing will also be such that, if Rett is approved after the Excellence readout, then after the rolling NDA filing is complete and reviewed about a say 14 month+ from now, Anavex will get that Paediatric Voucher.

I sense some posts reluctantly already beginning to get this scenario, well done Joseph!

As Joseph also points out, the potential AA scenario we have now heard from Anavex (and some simply just had confirmed), means that Anavex completed a P2b trial with surrogate endpoint biomarkers - awesome! Not! As it turned out a P3 Pivotal trial leading to traditional approval - wildly optimistic and misguided.

Hopefully, the all endpoints met 8K filing and associated repeated claims will not cause much of an issue, especially if Rett is approved and AA ends up being granted. Everything, rightly will be forgiven.

This is all probably hard to swallow for some, while obvious to others based on evaluating the fumbled P2b/3 readout and the lack of certain data and associated information. But chill, it all ultimately is the best strategy available to Anavex, imo!