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Posted On: 07/24/2020 3:16:57 PM
Post# of 145881
Quote:Agreed. Although, assuming the M/M results are good, I imagine they have the most value, and offer the most leverage, if they are released PRIOR to the DSMC's look at the S/C.
They are either trying to substantiate/build their case, or they are dragging in hopes that S/C can join the party.
As I understand it, the DSMC's investigation leads to one of three possible conclusions:
- Terminate due to futility
- Continue to 50% (195)
- Terminate due to overwhelming benefit
Again, as I understand it, there's no unblinding of any data to the sponsor (CytoDyn) or the public. I don't know if data is provided to the FDA.
I would hope the scope of the DSMC's investigation is broader than just looking at the primary endpoint (Day 28 Mortality), but I'm not sure they will have access to Dr.BP's lab assays, which we know are being conducted, and which will likely tell a compelling story.
I assume the DSMC is given a mandate to consider ONLY the results of the S/C trial that is before them, and nothing else. In spite of that, I think the release of the M/M results offers the most leverage (either with the DSMC or the FDA) if it precedes the DSMC's involvement.
Assuming the M/M are strong, I imagine putting the data in the hands of the FDA (not just issuing a PR) before the DSMC begins its investigation may possibly be the best approach.
But this is all pure conjecture on my part.
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