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runncoach

09/26/22 12:46 PM

#20243 RE: InTheTrenches #20242

There is a reason the company changed the window from 30 to 90 days. Over abundance of caution likely being the main one, but just as many of us here wonder (speculate) on why the placebo increased scores even when reflected for placebo imbalance at 13 weeks, the company is looking at all possible variables. This one stands out to me. I could also see IV delivery creating an initial larger placebo effect that would wane over time, but my understanding is some other competitor drug trials have been IV. Any speculation we may give to this issue would seemingly be of little importance at 28 weeks however and make the current trial even more likely to succeed due to a larger delta between placebo and byrostatin treatment.

I'm thinking 3 weeks to trial completion and 10 to 11 weeks until top line readout. JMHO

Cyosol

09/26/22 1:24 PM

#20246 RE: InTheTrenches #20242

We'll just have to agree to disagree then, because I think you guys are blowing this Memantine washout thing way out of proportion based on a 2% improvement in placebo patients.

From the 2022 paper:

"In the Moderate Stratum Cohort, the imbalance was much smaller, reporting a treatment group difference of 3.8 points in the means and 4 points in medians of baseline SIB scores (mean and median baseline SIB=86.8 and 89.0 in the placebo arm, and a mean and a median baseline SIB=83.0 and 85.0 in the bryostatin arm)."

Placebo patients going from a mean of 87 to 89 after 3 months is not that big of a deal imo.

Plummy Potter

09/26/22 4:53 PM

#20258 RE: InTheTrenches #20242

But the last trial was imbalanced in favor of the placebo (i.e. they scored higher on initial SIB test) and if this theory were true you'd expect to see the opposite.