Synaptogenix Inc (SNPX)

[InTheTrenches]

This is GREAT news!

I was really hoping there would be a legitimate reason why there wasn't a statistically significant response in the Phase 2 trial, when comparing the phase 2 to the compassionate use patients. Now we have a scientifically based plausible reason.

Now the hard work starts:

Designing this trial is going to be a bear for a few reasons, which is probably why they are bringing an academic institution on-board to design the trial.

First, will they do a trial that shows superiority or non-inferiority. Based on the post-hoc subgroup analysis, they will need to run some statistics to see which trial will do best. Non-inferiority will be more likely to succeed, but will probably require many more patients (longer, more expensive). BUT, if they run a non-inferiority trial, Bryostatin will not necessarily move to first-line treatment. IF they can run a trial that shows statistically superior results, Bryostatin moves to first-line treatment, which is obviously much better financially.

Second, Aricept and Namenda are oral drugs, and Bryostatin is IV. The problem here is, in order for this to be double-blind placebo-controlled, every patient will have to receive IV (drug or placebo) AND oral (drug or placebo). Doable, but a bit cumbersome.

Speaking of IV...is it possible to combine Bryostatin with EnHanze (Halozyme) to convert Bryostatin from an IV drug to subcutaneous (SC)? Anyone have a line to the company to suggest this? Would make Bryostatin much easier to use, but perhaps this is a consideration post-approval.

If they try to do a registrational trial (complex, expensive), I hope NTRP signs a lucrative partnership. As someone stated before this is probably the best path to get Bryostatin to market the quickest.