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  4. CytoDyn Inc (CYDY) Message Board

Same, but I’m confused by the difference between

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Post# of 155054
(Total Views: 738)
Posted On: 07/14/2020 12:20:41 AM
Posted By: blafarm
Re: ClosetInvestor #42842
Quote:
Same, but I’m confused by the difference between a interim analysis at 50% enrollment and vs a periodic safety review conducted by a DSMC (which is what CYDY will be doing next week). Is. A progressive analysis of the other endpoints part of the safety review, or is it just deaths and other SAEs?

I'm quite sure someone else can do a better and more accurate job of describing this process, but my understanding is that one of these three outcomes is possible:

1. The DSMC may suggest stopping the trial because of treatment (leronlimab) toxicity or efficacy shortcomings compared to placebo

2. The DSMC may indicate that leronlimab is working, but suggest the trial continue to 50% (195) or 100% (390) of the protocol. As a data point, I believe we were at ~131 enrolled as of last Thursday, but remember each enrolled patient must complete the 28 day trial duration. It's too bad CytoDyn's trials are not more focused in the states that are experiencing the most dramatic infection rates.

3. The DSMC may say stop the trial right now as leronlimab is obviously and undeniably working and it is morally/ethically perilous to allow any more placebo patients to die under these circumstances. I think it is safe to say that this is what both CytoDyn and investors would like to see happen.

I don't know what the DSMC looks at. I would hope it would be more than just the primary endpoint, and I would hope that it included Dr.BP's assays.


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