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OFP

Re: seventhwave post# 92751

Wednesday, 02/22/2017 8:45:19 PM

Wednesday, February 22, 2017 8:45:19 PM

Post# of 466734

3. Have any Alz drug trials exhibited an upturn in MMSE or ADCS-ADL for the entire study group, not just for a cohort.


I don't know of any even with proven treatments. Certainly none for indefinite time frames because nothing exists that has been shown (or even close) to reverse AD.

4. While MMSE is the most reliable measure acknowledged by peers, is it fair to say it FULLY/COMPREHENSIVELY captures and reflects changes & progression and therefore qualitative reporting of benefits is redundant and shouldn't be considered by the FDA?

First, I'm not sure I agree or know that MMSE is the best measure, just that it was the most important one that was available in this study. Qualitative reporting is fine at this stage..but not very useful or weighed very heavily in terms of approval decisions.

5. Are your statements setting expectations, implicitly assuming the entire study group was optimally dosed to full strength?


I'm not sure what expections I'm setting. I'm merely commenting on expectations/results AVXL is describing in patients dosed as they were dosed. I can't say how "full strength" dosing would change things.

We know Anavex has dropped their claims of synergy with DPZ and that DPZ may be a hindrance, not to mention sup-optimal dosages of 2-73 among patients.

I didn't know this..in fact I'm a bit surprised if true. I think one of the bigger disappointments of this trial is that they didn't show an indication of possible synergy as per the mouse data but I don't think a non-placebo trial can really disprove it and I'd expect they will need to have significant numbers of patients on DZP for their subsequent trials so I consider it an open (though now somewhat more doubtful) proposition.

Are you a prospective investor - just curious as to where you are coming from.

Prospective only at this point. See my preceding post for more specifics.

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