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Re: None

Sunday, 02/21/2021 9:19:38 AM

Sunday, February 21, 2021 9:19:38 AM

Post# of 16706
I think its important to restate the fact that any signal that they get from the final data is going to be subtle given the nature of the virus and the reasonably high recovery rate for standard of care. if you play around with the numbers, its easy to see how the differences in case numbers for intubation (assuming a moderate effect for ifenprodil) could be single digits. its the same reason why it would be understandable why they would bump the interim data sample from 75 to 123. at a sample of 75 even if they half the rate of intubation it only results in a difference of a couple of patients.

I acknowledge that I don't fully understand the rules for interim data and whether or not changing the sample size at the last moment is acceptable (at least the analysis was done post treatment for the entire sample so there is no risk of bias). wouldn't the DSMB have been involved in the process for analyzing/sharing the interim data?

interested in others thoughts on this (including/especially different takes).

still cautiously bullish.