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blu_1

08/21/23 6:07 AM

#427956 RE: Investor2014 #427955

Why are you so obsessed w/a stock you despise? Gee, I wonder? Send my regards to your buddie Adam.
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sab63090

08/21/23 8:18 AM

#427966 RE: Investor2014 #427955

Of course this goes back to 1st Qtr 2022, but Charlie Duncan is an old pro and well respected especially with his pointed questions...I don't really follow all of the details but you pointed out the interesting missing information.

I do realize that Charlie Duncan is not well liked here and most argue that it's because of Avanex not doing business with them.

I don't think Duncan currently "follows" Avanex.

This is getting interesting for Excellence Trial results...kind of worn out with the ongoing lack of data.
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12x

08/22/23 1:49 AM

#428093 RE: Investor2014 #427955

10Q didn’t mention detailed endpoint change but did disclose the endpoint change was approved by Australia and UK regulatory authorities. In the subsequent CC, Missling did indicate the company contacted FDA and gotten guidance on the endpoint (which is to be consistent with Acadia and US p2 trial).

Based upon the input from the successful U.S. Phase 2 Rett syndrome trial (ANAVEX®2-73-RS-001), we updated the endpoints for the AVATAR trial (ANAVEX®2-73-RS-002) to appropriately assess the clinically meaningful outcome following International Conference on Harmonization (ICH) guidelines. These updates were approved by the respective regulatory authorities in the U.K. and in Australia, respectively, where the AVATAR trial was conducted.



With regard to primary and secondary endpoint having the identical AUC graphs, I recall it was brought up in the results CC. Missling’s answer is that’s a coincidence. The graphs are correct. With the results just a patient count percentage 72.2% and confirmed in 10Q, I buy it as a coincidence.

secondary efficacy and safety endpoints, with consistent improvements in primary efficacy endpoint, RSBQ response (p = 0.037), and secondary efficacy endpoints, ADAMS (p = 0.010) and CGI-I (p = 0.037) response.