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Re: tcm55 post# 26850

Friday, 10/16/2020 11:46:27 AM

Friday, October 16, 2020 11:46:27 AM

Post# of 44695
Well... the first 21 patients showed a P<=0.0001, which is WAAAY better than the FDA wants to see. Since then, Javitt has mentioned that they are seeing similar results with the "open label" patients (which are results the company has seen, but we have not yet seen, and we suspect that data has been shared with the fda), and in addition to that, we are expecting the unblinded peek at the 102 patients in 2 weeks. If we end up with a P-value anywhere close to P<=0.0001 with all that data, then it would be unethical to continue trials. Javitt seems to be expecting the trials will be stopped in 2 weeks:

"The Covid study is moving forward with incredible velocity. We expect to read out the Phase three trial by the end of the year. But, two weeks from now, there's going to be a meeting of the data safety monitoring board (DSMB). And they're going to review the first 102 patients in the trial. They have the potential to see both futility, which we hope they won't see, or perhaps they will see overwhelming evidence of efficacy. Either, which would lead to STOPPING THE TRIAL."

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