Replies to post #303059 on Anavex Life Sciences Corp (AVXL)

[frrol]

Got it. And as for Missling, I think what he's saying ("positive resonance") at the end of that quote is what I was saying: that strong Rett results could benefit the regulatory view of strong AD 2/3 results. I think.

[georgejjl]

I believe that there is a 95% likelihood that the current phase 2b/3 early Alzheimer's disease trial is a pivotal trial and that FDA approval for marketing and sales will come after submittal of the results from this trial. The FDA may require a addition follow-up data from a Phase 4 post-market studies, which Anavex will undertake after a drug is approved and at the pharmacy.


GOD bless,

[boi568]

For purposes of your point -- that SAVA may be ahead in an FDA approval timeline because it has scheduled two concurrent trials -- you have to be assuming their success in each trial. There is no basis for this. The two trials are not even measuring the same thing; one checks for symptomatic relief and one for disease modification. How can one confirm the other? Even if SAVA only provides a safer version of Aricept (likely), its longer term study will fail the primary endpoint. Two trials can only be better than one if both succeed.

[bas2020]

I feel that the 2b/3 could be a pivotal study but that 2 pivotal AD trials will be necessary for approval

Very surprised by this comment. There is absolutely NO reason for TWO pivotal trials in AD, especially with a strong efficacious signal, very low to no AEs and a monumental societal healthcare need.

When 2-73 becomes approved after AVATAR or EXCELLENCE, there will be immediate approval for AD upon the clearly positive results of the P2b/3 trial. It's likely why the trial is being over enrolled.