CD12's DSMC suggested no changes to a clinical tri

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CD12's DSMC suggested no changes to a clinical trial for which they knew for certain the power would fail. Surely CYDY knows the power will fail as well.

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The initial patient number (which goes to power) in the protocol was sized for the anticipated success rate + a margin of error. That the DSMC didn't recommend an increase in size of the trial means that at the interim it looked like they would still achieve that level of efficacy at 390 patients.

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The DSMC observed placebo deaths between day 28 and day 42, and asked for an additional 42 day endpoint. But CYDY, despite knowing that the inherent mathematical weaknesses in CD12, did not change the endpoint.

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The DSMC asked for that 42 day extension because at 75% (293 patients) they saw that the primary would be statistically significant with the lower population and the slightly higher number of deaths at day 42. With 390 patients the additional deaths would become unnecessary. With the slower enrollment they would have deemed it better to get the trial finished faster to get approval and help out patients sooner. The fast enrollment to 390 made that unnecessary.

For the Sanofi trial inclusion/exclusion criteria looks like it tilts a bit less severe than our trial. That trial was also vs. SOC. Our mortality rate shouldn't be to far off from that trial.

https://clinicaltrials.gov/ct2/show/NCT02735707