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Friday, November 09, 2018 1:49:17 PM
Is this a check on safety by the data safety monitoring board (DSMB)? If so, we won't see any information on efficacy at this interim.
Or are you saying this is an interim STATISTICAL analysis? If so, this would mean that this is a pre-specified unblinded statistical analysis on the EFFICACY of the drug and management can view that information and may release it to the public. BUT, there will also be a corresponding hit to alpha in the final statistical analysis, which means it will be harder to reach statistical significance in the FINAL (trial end) statistical analysis.
If management views this as a possible registrational trial, then doing an interim STATISTICAL analysis for a drug that hasn't had a placebo-controlled trial would be like playing Russian Roulette with a 2-chamber gun.
Therefore, my best guess is it will be an interim SAFETY analysis next year, with no report on the progress of patients other than that the drug is well-tolerated and not many patients are dropping out. In the scheme of things, I think that result is to be expected.
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