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?