Replies to post #2678 on Synaptogenix Inc (SNPX)

[SF Wolf]

This was posted by runncoach over at the Investor Village NTRP Board:

"Has always made me wonder if the FDA knew the drug was working at that point and willing to do what it took to get the drug to the next stage of testing. The timing of the request would have been around the same time the first dosed patients had completed their 17 weeks I believe. If they were receiving universally positive anecdotal results at that point, it could explain why the company became so positive and big investors ponied up for this latest 25 million round. JMHO

http://www.investorvillage.com/smbd.asp?mb=19529&mn=64&pt=msg&mid=17020303

[frontiers]

SFW -- the original Ph 2B trial protocol was as follows:

"In this 28-week study, participants will be randomly assigned to take either one of two doses of the study drug or a placebo, administered intravenously every 2 weeks. There will be seven doses in 12 weeks. After the first 12 weeks of treatment, subjects who took bryostatin will be randomized a second time to receive either 20- or 40-microgram infusions for an additional 12 weeks (another seven treatments). Participants who took a placebo in the first phase will receive either bryostatin or continue placebo treatment for 12 weeks."

Jeffrey Bennison told me that they decided to eliminate Part 2 of the above protocol involving re-randomization and replace it with an open label extension study of the same duration -- the change was made in July 2016.They figured they would learn more from the open label extension than from re-randomization.

Is this the change you referred to in your post? Why does this change suggest to you they expect a positive outcome?