“Management will discuss the recommendations of the Data Safety Monitoring Committee (DSMC) ..... including a potential regulatory path forward.”
At first i thought this statement in the press release was another CYDY bungle because the sentence was grammatically incorrect.
In my (albeit uninformed) opinion, DSMB recommendations do not include "regulatory paths forward".
DSMB recommendations are limited to one of four choices:
1) stop trial for safety. the drug is too dangerous.
2) stop trial for futility. no chance to meet the endpoint
3) stop trial for efficacy. unethical to withold treatment from placebo patients
4) continue trial. we'll see.
I don't see "regulatory paths forward" in those choices.
So I just assumed bad grammar by CYDY.
What Cydy was trying to say is that the DSMB will give its recommendation, and then after that CYDY will discuss potential regulatory paths.
But alas, I am victimized by my own particular obsession: Dr. Seethamraju.
If the FDA really did review the unblinded data as Seethamraju claimed, then perhaps the DSMB recieved a regulatory path recommendation from the FDA.
And now it occurs to me that the CYDY press release was not bad grammar.
Perhaps CYDY did receive a "regulatory path forward" recommendation from the DSMB.
And it further occurs to me:
Is this the first and only time that a DSMB has made a "regulatory path forward" recommendation?
Does a protocol even exist which includes the possibility of a DSMB making a "regulatory path forward" recommendation?