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Posted On: 09/18/2020 11:58:33 AM
Post# of 148908
I agree that this is most likely the case.
From my understanding, AMAREX will collect/compile the data and DMC will conduct the interim analysis and issue a recommendation. NP explained (tried to explain) the process in a PI video, starting 6:40: "28 days need to go by, the week after that there needs to be analysis of the patients [that is ambigous, I think he means compiling the data] so that we give it to the DSMB so that they do interim analysis , if the interim analysis is solid, we hope to get approval, if it is not as great as we want it to, we will perhaps finish the trial, if it is disaster, they will stop the trial [...]."
https://www.youtube.com/watch?v=Bu1R95gzATY&a...j_8Db9o98c
I have asked these questions to Dr Dhody and the company, but didn't receive an answer. I invite you and others to ask the same questions, perhaps you will get an answer. That would be important to know!
From my understanding, AMAREX will collect/compile the data and DMC will conduct the interim analysis and issue a recommendation. NP explained (tried to explain) the process in a PI video, starting 6:40: "28 days need to go by, the week after that there needs to be analysis of the patients [that is ambigous, I think he means compiling the data] so that we give it to the DSMB so that they do interim analysis , if the interim analysis is solid, we hope to get approval, if it is not as great as we want it to, we will perhaps finish the trial, if it is disaster, they will stop the trial [...]."
https://www.youtube.com/watch?v=Bu1R95gzATY&a...j_8Db9o98c
Quote:
Furthermore, the following section suggests that prior to the interim analysis (and even the start of the trial), CYDY should have established a "statistical monitoring plan" and "early stopping boundaries" with the FDA. Presuming this has been done, I'd love to know the specifics of those statistical boundaries and if they are significantly different from what's been thrown out in some other posts on this board.
I have asked these questions to Dr Dhody and the company, but didn't receive an answer. I invite you and others to ask the same questions, perhaps you will get an answer. That would be important to know!
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