Synaptogenix Inc (SNPX)

[runncoach]

The thing that will eventually prove out or not is how our delta continues to differentiate itself after week 13. Namenda does absolutely nothing after week 10 or so except accelerate to the down side so it will be very interesting what we see at week 15 in this trial in larger numbers. Week 15 is NOT primary endpoint however.

Now its almost a certainty we'll run a similar length trial to Namenda for essentially 6 months instead of 13 or 15 weeks we're getting data for now. That's my opinion based on other FDA AD trials. If they think 94% improvement is worth some type of provision approval (if it happened again) then that's in their hands. I do not expect to cut that corner however. I feel a 200+ P3 pivotal trial will be needed.

If week 15 proves out as an exploratory measure again then we know we're onto something special as the synaptogenic effect would be shown to be the primary driver of cognitive reversal and not just the "nibbling at the edges" effect current drugs go for, such as anti-inflammatory or HDAC inhibitor, or antioxidant for example. We know bryostatin works on those as well but its the synaptic growth and repair that's reversing the disease. Point being, a delta of 4 would result in stat significance and be huge. A delta of 6 is going to show monster significance. A delta of 8+ like we saw at week 15 last time would show that there is likely more improvement ahead as a second bryostatin cycle is undertaken and that the delta at week 20 or 24 or 26 will show even greater separation. IMO and folks that really know this science believe that a P3 would be even more dramatic that the 2B will be because they actually understand current SOC data and even leveling off the decline after week 15 for bryostatin would be a monster breakthrough drug. JMHO