My letter to Anavex-IR/Clint. I highly doubt I'll hear back -- and/or it will have any impact. But, I just had to do it. The good part is that Clint was extremely prompt to my first email regarding the data flaws in the CTAD presentation (he wrote back at 4am EST), So, maybe ....... it will help. (If he replies, don't count on me on sharing the exact words).
BTW, during the SRPT's approval saga in 2016, I thought there was a strong flaw in FDA's analysis in the briefing docs, and was compelled to directly write to someone very high up at FDA (think Dunn's head and above, but not revealing the name). That person wrote back immediately (like in 15-20 mins), and said something like "I agree. Send me more points if you wish"). And, to this day, I believe that perhaps my email made a difference (but who knows), since that person was very instrumental in the final approval of the drug.
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Dear Clint,
I want to convey the perception of investors and analysts regarding Anavex.
Over and over again — in particular, in case of AVATAR trial and now the P2b/3 AD trial — Anavex has manufactured new endpoints and evaluated the trails based on these. More importantly, they have ignored evaluation of the original endpoints. Anavex may disagree, but thats the (seemingly valid) perception of the investors and scientists. Most unfortunately, the perception is that same mistake may/will continue to happen for future trials.
Specific examples.
1. In case of Avatar, the company came up with RSBQ-AUC endpoint at the last moment. And, unfortunately, never released the original change-in-RSBQ endpoint.
2. In case of P2b/3 AD trial, the company came up with threshold-based endpoints based on never-before-revealed thresholds. Again, most unfortunately, the company has not released the original change-in-ADCS-ADL endpoint.
RECTIFICATION (if Anavex cares): Release results of the original endpoints and/or answer any questions regarding data inaccuracies. In particular,
1. Release mean-change in RSBQ (not AUC) values in AVATAR.
2. Release mean-change in ADCS-ADL values in P2b AD trial.
3. Clarify a few doubts about the data values in P2b AD trial. (I can send you a short list, if you wish).
I hope you pass on the above feedback to the management. That is the best we (scientists and/or investors) can do.
Thanks for your time and consideration. Your previous reply and promptness was most appreciated.
<Name and Signature/Title>
