Anavex Life Sciences Corp (AVXL)

[Investor2014]

If it so obvious, obviously Anavex should and would have provided the basis for their claim long ago.

Obviously, they had enough combined data to make a claim of success with supporting calculations. They continue to reiterate their claim and haven't retracted their PR or the calculations.

I doubt we will ever a get a per protocol 30mg and 50mg set of results vs placebo.

My take is there will be no further P2b/3 data update before the peer reviewed paper. That paper, imo will as the P2a paper, have to rely on subgroup analysis to show where the strongest signal is and to what extend it mimics the P2a conclusions.

There may potentially be further specific criteria that pin points responders and of course finally how many responds better that SOC, our missing Odds Ratio n.

The question I have to this, if it turns out to be correct, is will the responder n be identified within the pre-specified analysis criterion and if so will it be sufficient for early approval. The alternative to early approval of course is a very well designed P3 Precision Medicine trial selecting for just the right responder enrollment profile.

Not much point in continuing exchanging these differing views. That is what it is and without further information neither of us are likely to budge.

Time will tell, but I won't be disappointed if my take on the P2b/3 outcomes is close to the outcome. This is because I think that is great outcome from a P2b trial that should provide very good chances of approval.

I would definitely be delighted if your contention of approval outside the rule of the FDA or with them is the outcome of the P2b/3.