Replies to post #102320 on Cytodyn Inc (CYDY)

[weasel6667]

Are there other COVID trials for severe/critical from our competition running in the same hospitals, where our trials are enrolled?
Anybody has researched that already?
How do the doctors decide on which trial they put the patients? How is their decision-making process? I assume the relatives of the severe/ critical patients have to agree in the first place for any trial participation.

[Venture_Cap]

Maybe they aren’t so desperate to join in for an unknown experimental drug or placebo when the SOC is better than before?

People do want to live typically.

[ombowstring]

You make a good point - "Remdesivir is not SOC for severe/ critical patients". There is no SOC for severe/critical. Therefore, the DSMC could have recommended to the FDA that the trial be stopped based on their own guidelines. But if the DSMC looked at the Phase 2b/3 on Monday and CytoDyn issued the press release on Tuesday, it's pretty obvious that the DSMC did not look at the lab data, did not compare how well patients in the leronlimab arm did vis-à-vis the patients on placebo, but only took a cursory look at the safety data and said, "Go ahead and continue with the trial" (or words to that effect).

https://www.fda.gov/media/75398/download

4.4.1.1. Monitoring for Effectiveness
In studies with serious outcomes, all parties would wish that any major
treatment advance be identified and made available as soon as possible. It is
critical, however, that the study yield a valid and definitive result. Thus,
tensions between ethical and scientific considerations may arise. Consider,
for example, a placebo-controlled trial of a new product for a serious illness or
condition for which there is no standard treatment. If the emerging data
suggest that those receiving the treatment are doing better, one might expect
that a DMC would consider whether the study should be terminated earlier
than planned. Estimates of treatment effect, however, will be unstable at early
points in a study, and the chance is substantial of observing a nominally
statistically significant benefit (e.g., p<0.05) at one of multiple interim
analyses during a study of an ineffective product (see Section 4.4.2). A DMC,
guided by a pre-specified statistical monitoring plan acceptable to both the
DMC and the study leadership, will generally be charged with recommending
early termination on the basis of a positive result only when the data are truly
compelling and the risk of a false positive conclusion is acceptably low.