Replies to post #117967 on Cytodyn Inc (CYDY)

[fsoalex]

Yes, the DSMC sees the data first, and as I have been told, if there is obvious efficacy then that hi level finding is communicated to the company and the company can decide to complete the analysis and submit the results. The decision to submit is with the company! So depending on where you are on the continuum both answers are correct.

[Gernee20]

Not following this thread, just jumping in, but often times the company DOES see limited DSMB data. Really depends on how the trial is set up.

I’m in invested in another company. Ph2 trial in girls with Rett Syndrome. The placebo controlled trial was set up in a way where prior to the 20 patient enrollment target began, an additional 6 patients were first in enrolled, who were guaranteed to receive the drug, of which the DSMB reviewed this data to give the green light to enroll the final 20 patients. The company was privy to this data, and in fact, PR’d the DSMB review, they approved to continue the trial with no changes, and in this PR the company shared positive data.

[DonDonDonDon]

If you email the company I think you’ll find that’s not the case. NP told me directly CytoDyn will not see the results, only the DSMB... They will only see it if the trial is haulted

Can anyone verify this? I knew that the first interim analysis was only for safety and that we wouldn't see results unless the study was halted.
But I was working under the assumption that we would see results from the halfway interim analysis of the first 195 patients regardless if the trial was halted or not.