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Millstone

12/08/16 8:20 PM

#82674 RE: A_Good_Day_2 #82672

Most here are waiting for the subgroup analysis. It seems that all patients as a group had the calculated improvement of +1.8 in MMSE and the +4 in ADCS-ADL versus historical placebo control studies.

Based on the wording of the press release describing a subgroup ("continued significant improvements from baseline of cognitive, functional and behavioral scores in a group of patients were observed") and the previous releases and presentations demonstrating an uptrend in improvement for the A2-73 only subgroup of 7, we are thinking that the data will show a divergence for this and maybe the MCI subgroup. This "in a group" language would make no sense otherwise.

The pooled data for all patients (originally 32) including both the "Anavex Plus" (A2-73 + DZ) patients and the A2-73 only group will show +1.8 in MMSE and the +4 in ADCS-ADL versus historical placebo control studies.

The subgroup data will show (I assume) a greater improvement in the 7 A2-73 only subgroup.
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frrol

12/08/16 9:06 PM

#82677 RE: A_Good_Day_2 #82672

Cognitive improvement in all drugs that showed any improvement have thus far been limited to temporarily slowing decline. That means results that dropped slower than placebo or historical control, and by small margins that don't last. What's "small"? Less than 2 points difference in MMSE decline during the first year. (Eg, if the plcaebo arm dropped by 4 points at week 52, the drugged arm dropped by a bit more than 2 and the rate of decline also eventually normalized.)

That's kind of our bogey. Looks like we beat that with a small sub group. If we beat it in a big Phase 3, NDA approval is almost assured. Still a lot to prove. Question is: did we proven enough to attract a BP partner?