Question for the board re Sandburg article in Insider Financial.
In his otherwise good piece, Sandburg seems to be saying that the DSMC might still be reviewing the 3/4 enrollment data.
It's my understanding that no one will be looking at any data until Jan. 12th, which is 28 days after full enrollment was reached.... that the DSMC will NOT meet again... but that 42-day-post-treatment data (for the 3/4s of the patients who are 42 days post treatment on Jan. 12th) might be considered as a part of the data. Is this how the wizened, wise folks on the board see it? TIA.
In his otherwise good piece, Sandburg seems to be saying that the DSMC might still be reviewing the 3/4 enrollment data.
Quote:On November 23rd the clinical trial reached 75% enrollment (293 patients) which opens it up for DSMC review. The primary endpoint was 28 day all cause mortality.... On December 21 the DSMC might peek at the data and see that there is a mortality benefit (primary endpoint) and recommend EUA approval or order that the patients on placebo are immediately given the drug. Regardless of how the DSMC or FDA act, CytoDyn plans on unblinding the study on January 12, 2021 with results “announced shortly thereafter.”
It's my understanding that no one will be looking at any data until Jan. 12th, which is 28 days after full enrollment was reached.... that the DSMC will NOT meet again... but that 42-day-post-treatment data (for the 3/4s of the patients who are 42 days post treatment on Jan. 12th) might be considered as a part of the data. Is this how the wizened, wise folks on the board see it? TIA.
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