Synaptogenix Inc (SNPX)

[runncoach]

"Again - 2-73 is not a "competitor" to Bryostatin"
And once again I wholeheartedly agree that 2-73 is not a competitor to bryostatin in any way, shape, or form...at least based on placebo controlled data compared to any metric I've mentioned (SOC or cognitive improvement) or anything I've seen.

Repost
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=144729025

CTAD summary for me without naming company names. All is JMHO.

You have one company running a huge placebo controlled FDA trial that has announced at some intervals the drug wasn't performing well but at others it is doing better so they add patients to the study to try to get better significance. Their goal of course is slow slow the rate of decline in early alzheimer's but they have a big issue with a placebo group that has an irregular number of APOE4 carriers compared to treated patients which could mean comparing apples to oranges when it comes to rates of decline. Also has some brain swelling issues in higher doses best I can tell. Result time line is anyone's guess at this point.

You have another company that didn't even run a placebo controlled trial, allowed patients to speak to the media early in the trial potentially contaminating results and is at least in part being run by someone who claimed incredible results for another australian company early in their treatment that turned out to be a failure. Also keep in mind they did not run PET scans on patients in their small study of patient numbers in the 30s. Then they present CTAD data on 21 patients without a real explanation of those who have dropped out and how their scores have been handled (F1ash has since linked to how it was handled using MMRM-LME)... so logic follows that these would be the better responders if any response at all who remain in the 21. Then they set a baseline and say a group of 8 had a higher blood concentration of the drug (apparently not a linear correlation however) and have a slower rate of decline than that of the other 13 patients, although those patients too have a slower rate of decline than baseline according to company. Once again no placebo control to aid in that measurement. Standard industry expectation of misdiagnosis (which has been linked multiple times) is 20%. If even ONE or TWO patients in the 8 patient cohort has been misdiagnosed, you would potentially be looking at a house of cards collapsing. It does appear that the drug has been administered safely in their trial and a 450 patient study is enrolling, expected to be completed in roughly 2 years.

Another company presents results from an exploratory, double blinded, placebo controlled FDA trial that included roughly 150 patients. It included 3 arms and one of the dosed arms showed clear advantage. When looking at the properly dosed arm it became obvious that by 5 weeks those that improved test scores, maintained them throughout the entire trial. Then they became aware those patients were not taking memantine and in fact 15 of 16 patients showed an improvement over baseline of over 8 pts which netted nearly 6.5 pts in straight scoring improvements on SIB scale, the test that memantine used to gain their approval. This 94% success rate allowed for great statistical significance and statisticians have been brought in to run a straight forward 100 patient study for non memantine patients. Confirmation expected next July although recently announced the trial is ahead of schedule with 37 dosed and a total of 82 had completed screening as of 10 days ago. Safety profile of nearly 2000 patients for a couple decades ran in FDA controlled trials.

Investors can choose at their own peril if they have a risk tolerance for AD companies who have an incredibly high failure rate in general.