Replies to post #2670 on Synaptogenix Inc (SNPX)

[Antti]

Nobody has to assume anything. Phase 2b results will soon tell us how effective Bryo is when given 3 months and also how do patients perform one month later without the drug (to see how well possible improvement persist without medication).

Possible longer term improvement will be a subject for open label extension and phase 3. But even if possible improvement doesn't last very long Bryo can be by far the best selling drug ever developed for AD.

You can be concerned about the seizures and anything else you may come up with. But that doesn't chance the fact that so far the safety profile has been excellent. No-one can know what happens in the future and there are always possibilities that some patients may get some adverse effects not discovered before. That's a natural part of developing new drugs and ALL drugs have these same challenges before and AFTER approval.

If effect size is anything like what many here are expecting (based on CU patients) then even three months can give us solid indication of disease reversal.

[Theburg]

"The approved drugs keep patients above baseline for <6 mos typically and then nosedive. Donepezil can be of benefit out to a year, best case."

Did any of these "nosediving" drugs for which you speak rebuild synaptic networks? Ok then.

[runncoach]

blu
You're going to get to see all that you ask. Of course the seizures are not what led to Jenni's pneumonia. The published study showed this and her family stated bryostatin wasn't the cause and in fact was "miraculous" and the FDA wasn't concerned either and continued to allow her treated even after the pneumonia hospitalizes her. My question to you was why do patients who took this drug for 12 weeks want to continue on if it wasn't working or caused bad side effects. I think we can surmise the answers to that. What's your thoughts on that.

In Neuroptrope's case if bryostatin doesn't work then the whole world will know after 17 weeks (12 + the final observation). If it does then the study moves forward and additional patients are added. Do you think bryostatin will show 12 week efficacy as the poster you copied here a couple days ago did? Don't you hope it will?

[SF Wolf]

blu, I believe most of your concerns, at this stage of the Byrostatin trials, will be addressed in the Ph2b open label and Phase3 study designs.

The question to ask yourself is why did the FDA allow Neurotrope to alter the Ph2b study in mid-course and to shorten its duration?

I would argue that that action is very unusual for the FDA.

Neurotrope would have had to file a petition with convincing back-up data for the FDA to agree to the changes.

That, in my mind, is the most compelling argument to date that NTRP will report a positive outcome in the Ph2b trial.

[XenaLives]

Excellent points... The more disruptive a drug is the greater the chances for negative side effects. I think that the restoration of cellular homeostasis as a MOA is what gives Anavex 2-73 its advantage in safety for long term use.

[BaerEssentials]

This is an honest question.... Is it possible/ethical that both NTRP and FDA view short term efficacy (<6 months) in SEVERE patients as acceptable regardless of long term side effects? If these unfortunate ppl don't have long to live anyway, what would it matter if there are side effects down the road? Without the drug, they may have died already - that is, by the time the side effect would have reared had they been on Bryo.

With the state of this terrible disease and the fact that we are getting nowhere with AZ, maybe this is actually a consideration.

Again, is it ethical to approve a drug for short term use and "study" those patients for long term side effects? Kinda like a mixture of compassionate use and approval.

Am I clear in my Q, or just rambling?