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Re: XenaLives post# 7246

Saturday, 11/10/2018 4:11:48 PM

Saturday, November 10, 2018 4:11:48 PM

Post# of 21521
Of course scoring metrics are a big issue IMO. How else can you judge the likelihood of passing a trial? Our competition is running its first ever placebo controlled trial. If you don't know how that data stacks up at 48 weeks vs placebo in a trial that is 20 times larger than before then IMO that increases risk massively no matter who is running the trial or what research that goes in IMO. Just dividing what's left of your own group into cohorts and saying one group's scores declined less than the other and they had a better concentration of the drug in their body isn't all that convincing IMO

It was the same gamble with NTRP over a year ago. You had to have faith in management and research and the CU patients but it was still a gamble. The fact we are still standing speaks a lot (I remember some posts claimed no need for further investigation of the drug) and as the data slowly came in and you realized it was successful in a big and stat significant way as long as the patients weren't on memantine it was astounding for the science. Then we realized that "black and white" meant 15 of 16 patients IMPROVING and much more de-risking had taken place. Then you take into account the current trial will be identical to the 20 dose arm last time except patients will have to go off memantine for at least a month beforehand and you have odds much greater than last time and as the data date approaches next year I'm sure there will be plenty of speculators dipping their toes.

My point is that with bryostatin you know the gamble. You know what the FDA is allowing. You know what the SOC score is. You know we have surpassed that already in a smaller trial (albeit with 94% patients improvement), you know when to expect results. You know its been proven safe and tolerable by FDA standards for years. You know that the FDA mandated neuroimaging in the screening process, etc. That's not cherry picking facts IMO. That's mitigating risks.
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