Replies to post #448847 on Anavex Life Sciences Corp (AVXL)

[mrplmer]

Respectfully if you truly feel that way way why are you here? Are you short?

[bas2020]

A most ridiculous statement...

Anavex AD drug has questionable/unproven efficacy at this point

These are the FACTS!

• Odds Ratio of ADAS-Cog meaningful improvement in cognition at threshold of -0.5 points or less (90% CI) 1.839 (1.17, 2.94) P = 0.015

• Odds Ratio of ADCS-ADL meaningful improvement in function at threshold of +3.5 points or higher (90% CI) 2.67 (1.17, 6.13) P = 0.0255

• ANAVEX®2-73 treatment slowed cognitive decline by 45% compared to placebo at 48 weeks
• Mean difference in ADAS-Cog score change of -1.85 points

• Compared to placebo, ANAVEX®2-73 (blarcamesine) reduced clinical decline of cognition and function by 27% with mean score difference of -0.42 points (p=0.040) as measured by CDR-SB

• ADCS-Cog and CDR-SB (p < .025) proving further evidence of stat. sig. improvements and trial success.

• Identification of two key biomarkers (Aß42/40 ratio and brain volume stabilization) for AA pathway option.

After reviewing all of the data (published and unpublished), the EMA recommended that Anavex apply for FULL APPROVAL.

[xodcode]

That doesn’t mean EMA approval chances are zero, BUT they are minimal IMO. FDA approval chances are near-zero, IMO.

I'll take TGD's $14 billion Karuna reference as an indicator of RETT and AD's chances of approval over yours, but thanks for your input.

WGT!

[Hosai]

So which drugs would you be recommending to AD patients instead?

[Joseph_K]

I agree with you that efficacy is the agencies' #1 consideration and that the P2b/3 did not meet all endpoints, which is why my first question for Doc was his estimate of the chance of approval if ADCS-ADL had met statistical significance for it such that all endpoints were met. Even though meeting all endpoints would have been better, I do give credence and weight to Jin's p<0.025 maneuver. You apparently don't. Adding in the clearly excellent brain shrinkage biomarker, and hopefully the amyloid and tau biomarkers, and maybe the OR results, I believe efficacy is probably sufficiently proven.

I think you dodged Hosai's legitimate question:

So which drugs would you be recommending to AD patients instead?

If blarcamesine were approved, so that you could choose between it and an approved MAB, which would you recommend? (Or which would you be inclined for yourself or a loved one to take?) Working from what we know of these drugs, I would choose blarcamesine. I believe agencies would come to the same conclusion, and, because they look at the totality of the evidence, I think they probably will approve.