I couldn't get your FDA link to work but I think this is the same doc:
https://www.fda.gov/media/75398/download
Just to clarify expectations for us (and wishing NP did more of this), this means that CYDY and its shareholders will most likely NOT receive any update on efficacy at the conclusion of the CD12 interim analysis .
The only possible exception to this may be in the case of the DMC recommending CYDY terminate the study due to observing a substantial benefit. But even in this (rare) case, CYDY must be the one to take action and reach out to the FDA, and it's not clear (to me at least) how that process transpires without CYDY getting a peek at the efficacy data.
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.
https://www.fda.gov/media/75398/download
Just to clarify expectations for us (and wishing NP did more of this), this means that CYDY and its shareholders will most likely NOT receive any update on efficacy at the conclusion of the CD12 interim analysis .
The only possible exception to this may be in the case of the DMC recommending CYDY terminate the study due to observing a substantial benefit. But even in this (rare) case, CYDY must be the one to take action and reach out to the FDA, and it's not clear (to me at least) how that process transpires without CYDY getting a peek at the efficacy data.
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.
Quote:7.2.1. DMC Recommendations to Terminate the Study
In almost all cases, a DMC is advisory to the sponsor; the sponsor decides
whether to accept recommendations to discontinue a trial. FDA will rarely, if
ever, tell a sponsor which decision to make. For trials that may be terminated
early because a substantial benefit has been observed, however, consideration
may still need to be given to the adequacy of data with regard to other issues such
as safety, duration of benefit, outcomes in important subgroups and important
secondary endpoints. We recommend that sponsors of trials that could
potentially be terminated early for efficacy reasons discuss these issues with FDA
prior to implementing the trial, when the statistical monitoring plan and early
stopping boundaries are being developed. In these settings, consultation with
FDA may provide the sponsor with important information regarding the
regulatory and scientific implications of a decision and may lead to better
decisions. Sponsors are encouraged to revisit these issues with FDA when
considering DMC recommendations for early termination if new issues have
arisen and/or if the regulatory implications of early termination were not
adequately clarified at the outset of the trial.
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