Replies to post #428586 on Anavex Life Sciences Corp (AVXL)

[ohsaycanyousee82]

Did someone spring Rikker from the Island?

[Investor2014]

Anavex would not announce plans to initiate a confirmatory AD trial if the P2b/3 trial was pivotal.

Anavex Life Sciences Reports Fiscal 2023 Second Quarter Financial Results

Alzheimer’s disease: Full data ANAVEX®2-73-AD-004, including newly available preliminary results of surrogate biomarkers of pivotal Phase 2b/3 clinical trial. The Company intends to discuss these findings with regulatory authorities in the context of the ongoing clinical development of ANAVEX®2-73 in this indication, with the goal of providing a much-needed treatment to the millions of patients living with Alzheimer’s disease with a convenient once-daily oral treatment. The Company plans to proceed in parallel with the initiation of a confirmatory Alzheimer’s disease study.

Here parallel refers to the preliminary surrogate biomarkers and considering initiating discussions with regulatory agencies for Accelerated Approval. Ergo the P2b/3 trial was not a pivotal registrational P3 trial.

With newly available preliminary efficacy results of surrogate biomarkers, we consider initiating discussions with regulatory agencies for Accelerated Approval Pathway for ANAVEX®2-73 (blarcamesine),” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex.

Definitions should NOT be ignored!

It shouldn't be too difficult for experienced biotech investors to understand the context and correct conclusions.

[Anshu2]

Haha. Level of cluelessness and/or blindfolded is astounding!!

This was a P3 trial. Ignore definitions. Go to clinical trial website, type in "anavex 2-73" and choose Phase 3 as a criteria and up comes this study. It is no less a P3 just because it was also labeled P2b. Efficacy and safety are everything - and in this case both were best in class.

[Joseph_K]

To me the evidence is too skimpy to say the P2b/3 efficacy results were "best in class" (though I agree regarding safety results). I'm good with us agreeing to disagree: Neither of us is going to convince the other until Anavex provides substantially more data and analysis of the trial results or at least the initial protocol or statistical analysis plan ... at which point which of us had been right really won't matter much to either of us!

As for Rikker and shorts, I just don't see this message board as influencing share price significantly ever, and certainly not in the medium- or long-term. As a result, I don't worry about it. I'd rather use the board to develop my own thoughts and learn things.