I'm "pretty sure" that PR implies that the Data Sa
Post# of 154873
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Posted On: 09/18/2020 11:32:08 AM
I'm "pretty sure" that PR implies that the Data Safety Monitoring Committee (“DSMC”) will perform the interim analysis, not CYDY employees. Although my confidence with interpreting CYDY PR wording is a bit shaky lately.
Per the linked FDA document, the idea is that the trial sponsor (CYDY) should not get a premature peek at any efficacy data before the trial ends, otherwise the the sponsor could become biased and the eventual trial results could be considered compromised.
Per the linked FDA document, the idea is that the trial sponsor (CYDY) should not get a premature peek at any efficacy data before the trial ends, otherwise the the sponsor could become biased and the eventual trial results could be considered compromised.
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