“but it's inaccurate to say it (the first GvHD t
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Posted On: 12/31/2020 11:06:02 PM
“but it's inaccurate to say it (the first GvHD trial) was halted for futility, unless you mean by this that the study was not feasable under the old protocol...
Halted for futility or halting because the study was not feasible under the old protocol are one and the same.
Remember, DSMCs basically have 4 recommendations they can make at an interim analysis: stop the trial for futility, continue the trial as planned, continue the trial with X changes or stop the trial for overwhelming and clear efficacy. In the case of the 1st GvHD trial, the DSMC recommending stopping the trial. Now, to be clear, the PR doesn’t state that the DSMC recommended halting the trial for futility. What the PR states is that the DSMC did their analysis and CYDY is going to change the protocol and keep the investors updated. In typical CYDY fashion, the meat is left out of the PR, but we know from the PR that the DSMC didn’t recommend the trial continue as planned, continue with X modification or stop due to efficacy. That leaves only one option: the trial was halted because there was no benefit scene in the first 10 patients and continuing the trial would’ve been pointless.
Halted for futility or halting because the study was not feasible under the old protocol are one and the same.
Remember, DSMCs basically have 4 recommendations they can make at an interim analysis: stop the trial for futility, continue the trial as planned, continue the trial with X changes or stop the trial for overwhelming and clear efficacy. In the case of the 1st GvHD trial, the DSMC recommending stopping the trial. Now, to be clear, the PR doesn’t state that the DSMC recommended halting the trial for futility. What the PR states is that the DSMC did their analysis and CYDY is going to change the protocol and keep the investors updated. In typical CYDY fashion, the meat is left out of the PR, but we know from the PR that the DSMC didn’t recommend the trial continue as planned, continue with X modification or stop due to efficacy. That leaves only one option: the trial was halted because there was no benefit scene in the first 10 patients and continuing the trial would’ve been pointless.
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