Replies to post #349362 on Anavex Life Sciences Corp (AVXL)

[WolfofMia]

I don't believe the FDA would proactively reach out to Anavex, or any company, with advice to change the primary endpoint and upgrade the trial from P2 to P3.

I was thinking the same, and I believe what it was meant to be said is that the discussion was had with the FDA.

Now since the FDA is not the approving body of these changes, since the trials are not in the USA, then they dont need to approve officially like UK and Australia do.

They could have acknowledge the change in any of their meetings.

Either way, we are good in that front as we changed the endpoint to a harder to meet one based on research and guidance that came out on the old one.

Still trying to understand how this is negative lol.

I mean I understand the spin reason, but not how serious investors would believe it.

[LakeshoreLeo1953]

While paraphrase caveat was freely posted up front....

As we can see, even in "clarification" questions arise.

Words matter??????

Not only is FDA outreach unlikely, it is NOT appropriate
under current Agency protocol (except as you noted).

[La Flaca]

The FDA is a big organization. AVXL has fast track and orphan drug status which, I understand, allows frequent meetings with FDA. It’s probable imo that the FDA docs on AVXL payroll are in communication with FDA docs through the appropriate committee within FDA who are getting advice on how to set up these trials for maximum likelihood of approval. I think this is what’s going on and PR at AVXL are not very precise with their messaging.

[Steady_T]

None of that is inconsistent.

We know that Anavex has fast track and other designations from the FDA that provide for "frequent meetings with the FDA". So having the FDA look at the progress on the various trials and requesting the trial be made a P3 is not out of the question. I can see the conversations going like "We have looked at all the data that you have collected on 2-73 and the initial Rett trial, the fact that the DMSB found no issues, so we think you should go ahead and make this a P3 trial."

Anavex would then need to go to the countries that are actually supervising the trials and request approval to make those changes. After all it is those countries whos rules the trials are being run under.

The FDA didn't need to be "proactively reach out to Anavex". Anavex is having frequent meetings with the FDA.

[RedShoulder]

Investor, I hear you. There is much conflicting and missing information across the board that I hope Missling will clear up in the next CC.

The truth is out there, getting it is another matter.