Replies to post #325174 on Anavex Life Sciences Corp (AVXL)

[boi568]

"Had only planned the PDD study as safety and PK information to decide whether a pivotal study would make sense, hence short 14 week study. Did not plan in advance to have 48 week OLE, but now very useful.

"He mentioned that the PDD ADS-COG 70% correlation to AD along with the SIGMAR1 biomarker results clearly stronger than the signal that got Aduhelm approved."

These comments reinforce further the force of the mRNA biomarker findings, something that Missling was not expecting to find (or he would have designed the PDD study differently).

I want to examine the PDD/AD 70 percent correlation remark in context. Missling is not going to be using a potential PDD NDA to promote the approval of the ongoing AD trial, obviously, although it does give a strong signal that the AD trial will also succeed. The fact that it may work in AD the same as PDD doesn't make the PDD case, alone, stronger. Instead, taken together the correlation and the validated biomarker strengthen his argument to the FDA that the mRNA biomarker, correlated for efficacy in both PDD and Rett 001, is very likely to do the same for Alzheimer's and all other CNS diseases that may involve the Sigma1 receptor. Missling is attempting to get the mRNA biomarker accepted as a CNS-wide biomarker that will ease his path in all future CNS NDAs.

Very useful report, Investor. Thanks for posting.

[RedShoulder]

A couple of other things Missing said paraphrasing:

Expect to see strong dose response curve between the U.S. adult Rett and high dose AVATER study important for data submission.

Had only planned the PDD study as safety and PK information to decide whether a pivotal study would make sense, hence short 14 week study. Did not plan in advance to have 48 week OLE, but now very useful.

He mentioned that the PDD ADS-COG 70% correlation to AD along with the SIGMAR1 biomarker results clearly stronger than the signal that got Aduhelm approved.

I wonder in what ways those 48 week OLEs will be "very useful" to Missling?

Many Thanks Investor for passing along the read.

Best I've heard so far IMO, is running two separate Ph-3 trials with PDD and also PD, and being potentially pivotal. Putting the Anavex portfoilio with 3 Ph-3 trials, in the top three market size positions in the entire CNS space.

We are so under priced on the MC and SP considering the reward side of the risk/reward equation. OTOH, the recent Rett trial results and the PDD/PD results have eliminated a great deal of the risk. Nothing is a 100% in Biotech, but I do like the odds of PDD/PD and Rett being commercialized world wide as Anavex winds it's way to multiple approvals.

[boi568]

The 48 week PDD OLE study is expected to complete on October 31. We had speculated last year that the 14 week study may have been too short to meet all the endpoints; Missling's remarks reported by Investor seem to explain why it was short, and that our speculation may have been on the mark. It will be fascinating to see the outcome of the OLE followup study, but it seems that Missling is already encouraged by it.

[raja48185]

I will take all of the info you shared as positive.

Missing still has to convince the FDA and sell it to them. Let us hope that he is ably supported by strong data.

[TempePhil]

Investor, those were the sort of things I was expecting to hear on the Thursday CC, because of the PR's "Company’s growth strategy" line.

Hopefully/maybe, we get some more great info on the CC!

It sounds like things are coming together.

Thanks for the report!