Anavex Life Sciences Corp (AVXL)

[Biostockclub]

Doc,

Possible last post in this thread before putting it to bed(?) and feel free to reply; fair to give you the last word. I’m closing the case here and yielding the floor.

The link to the Rogers study which contained 473 (same one as cited - the 436 was a typo which was confusing, apologies. But, in my math equation, I used the 473 number which could have demonstrated the error - no matter) patients and was conducted in the US. We link to the same study. The other ph3 Rogers study which came later was only 15 week study with 400+ patients and according to the watermark link from last post, was not taken into account when determining approval.
So, really it was based on one trial although a second very short one was conducted but was not required and was not considered.

But, if we look beyond this, much can be gleaned by lining up the similarities and differences which is what many investors (and people of earth) would like to know, about the chances of our drug being approved.

https://pdfs.semanticscholar.org/224e/3ecc85f5470cc8e50066b0d08688191bb4ec.pdf

All of the pertinent scores and dropout and side effects including the fact that the lower dose of the med did as well as the higher dose, are included in this article.

Our dose was not optimized and scores for correlative tests were in same range. All we lacked in our group were larger sample and placebo. Now, factor in a larger group with placebo arm, but, then, add patients will be dosed at MTD correlating with higher blood concentrations and performance, and add the gene variants. Also add the fact that we are trailing for 48 weeks, DZP was for 24?weeks. Now add that this is being conducted in Australia. And lastly, there is no longer an agreed upon SOC.

That is the bottom line.
We can use the fact that DZP was approved in the US then attach our additional parameters to the results from the Aus 2a: placebo arm, larger n (but same size as the Rogers 473), longer trial by 2 times, knowledge of the MTD and necessary blood concentration to make our 2 dosed arms prove out that higher doses correspond to better outcomes, gene variants to lay down a biomarker, and Australian host country, and the now current lack of any SOC, to extrapolate what our company’s goals and objectives are with this trial, and if they can be met. I believe that, if they can be met, our drug will be approved out of this trial by Australia. It could even be approved before that based on the extension alone, if it is approved for another indication first, especially with the genetic biomarker established.

There can be little dispute that the history of what was approved and what our company is embarking upon are not apples to apples, so speculating what additional steps might be needed for approval is too slippery to envision at present, in my opinion. I would not suggest that we have 2 more trials to conduct...it is as likely we could have approval in one half of this trial time - based upon the gene component, and optimized dose throughout the trial. Or, as mentioned, based on approval for another indication with no RCT. Additional mud in the water: the disease is more prevalent, more costly - globally...a crisis, and there is no longer any SOC as the 4 previous drugs have not planned out (respect for your honesty in acknowledging that Aricept is not a very good drug).

Since, neither of us possesses a crystal ball, I’d consider it reasonable to agree to disagree on what further steps may be necessary. Perhaps, we see the glass filled to different levels.

I was questioning the fact that you posited that another even larger trial, multinational, will be necessary for approval and I simply did not see that happen in the case of Aricept, therefore posted that it was not a likely requirement.

It’s still too early too tell if either of our posts have any merit as to how things will actually pan out.

Am willing to bet we both would like to see all patients have the hope and benefit of a successful drug.

Best regards, Doc,
Bio