I agree, which is why I was counting them. Maybe
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Posted On: 02/05/2019 8:12:34 PM
I agree, which is why I was counting them. Maybe NP misspoke, he tends to do that sometimes. I did find it odd in the PR they listed the 40 recruit for mono when listing the 700mg numbers.
But did list the extension numbers
They could have stated: with mono and ongoing combo patients, we currently have over 100 on 700mg, and left it at that.
Also NP said they fda had meet to discuss combo before the meeting, so I suspect that is the last hurdle.
Assuming they do have 100 now for safety.
Why enroll more now for mono, with the possible pivotal trial starting?
It is a waste of time and money unless
1) needed for safety for mono
Or
2) fda wants a bigger sample on 700mg for mono before deciding on the pivotal trial
Or
3) fda said those on 700mg could be counted in the pivotal trial
For Combo it made sense for the fda to allow the switch to 700mg. NP was asked in a CC about it, but he didn’t want to switch because he thought they would require a new trial. But the FDA is looking at it from a patient benefits perspective.
Also similarly their idea of an induction period for 6 weeks and the start trial is just a math trick allowing them to discredit the failures during the first 6 weeks. I suspect the FDA is smart enough to notice and consider that without changing the trial design, and thus might have said don’t change the design and we will allow the old 700mg patients in the pivotal trial.
Quote:
CytoDyn currently has 45 patients enrolled in monotherapy with 700 mg, 29 additional patients who have switched from lower doses to the 700 mg dose and over 40 patients currently in screening to initiate 700 mg dose arm of monotherapy trial.
But did list the extension numbers
Quote:
The FDA also gave CytoDyn permission to upgrade all ongoing patients who are currently on 350 mg in the combination therapy to 700 mg dose.
They could have stated: with mono and ongoing combo patients, we currently have over 100 on 700mg, and left it at that.
Also NP said they fda had meet to discuss combo before the meeting, so I suspect that is the last hurdle.
Assuming they do have 100 now for safety.
Why enroll more now for mono, with the possible pivotal trial starting?
It is a waste of time and money unless
1) needed for safety for mono
Or
2) fda wants a bigger sample on 700mg for mono before deciding on the pivotal trial
Or
3) fda said those on 700mg could be counted in the pivotal trial
For Combo it made sense for the fda to allow the switch to 700mg. NP was asked in a CC about it, but he didn’t want to switch because he thought they would require a new trial. But the FDA is looking at it from a patient benefits perspective.
Also similarly their idea of an induction period for 6 weeks and the start trial is just a math trick allowing them to discredit the failures during the first 6 weeks. I suspect the FDA is smart enough to notice and consider that without changing the trial design, and thus might have said don’t change the design and we will allow the old 700mg patients in the pivotal trial.
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