Replies to post #369203 on Anavex Life Sciences Corp (AVXL)

[Gator328]

I haven’t paid much attention to Anavex recently. Why did they change the endpoint for Rett?

[Investor2014]

Eactly right! I really do hope Dr. Missling has learnt that lesson.

[frrol]

TLDs can be limited for legitimate reasons, so why only some components of the PDD trial's CDR battery endpoint were released while others were not with no explanation is puzzling. Biotechs often and unnecessarily cherry pick and open themselves up to criticism. For Rett, the shift to AUC was adequately explained, but not properly handled. Throw in the conspicuous yet unaddressed lack of dose effect and, again, the company opens itself up to more questions. (Perhaps dose effect will be seen in the OLE results, though it is unclear if we'll get them for Rett.)

Nevertheless the potential signal is there, and our clinical programs are proceeding. Watch for the PDD OLE and AD phase 2/3 results.

[ignatiusrielly35]

Doc, I agree with your assessment of what types of results will enable what extent of negative spin. However, I disagree with the premise that the Adam Fraudsteins of the world will not put out a hit piece even if the results are unequivocally good. People like that can ALWAYS invent some nonsensical rationalization for a negative implication.

[growingpain]

Doc, it is clear to me that they did not release this continuation of attention for PDD and the original endpoint (RSBQ raw change) for Rett because they were not met in a statistically significant manner. Otherwise, we would have heard of both by this point.

The reason I continue being long is that I believe the reason behind a pval>5% is the small sample and not that the drug does not work. Statistically significant or not, all the data we have seen collectively indicate that 2-73 is better than the standard of care, at least for Rett and PDD.

IMO, Missling messed it up by going small. He might have thought that the effect would be so large that the small sample does not matter. He even defended this point in a couple of calls. I think he finally realised that he needs larger cohorts and this is the true reason behind expanding the Excellence trial.

The two upcoming readouts will be the endgame for 2-73 IMO. Both samples are of a good size to show whether 2-73 will be eventually approved or not. For Rett, I strongly expect approval. For AD, I expect to see some efficacy for the high-dose cohort and then a P3 or P4 trial to confirm that. Just my two cents.