It may be that the DSMB looked at 14 day and 28 da

Quote:

---

It may be that the DSMB looked at 14 day and 28 day patients??

---

thrifycents,

I think you're on the right track, but allow me to take it one step further.

If we are to believe Dr.NP that the DSMC was ONLY looking at safety and not efficacy, then there would not have been a need for any endpoint threshold to have been achieved (neither 14 nor 28). In other words, the entire universe of treatment arm subjects could have been reviewed for AE or SAE.

It seems we're not getting the full story here.

1. After Dr.NP backpedaled from his former assertion that 50 subjects could be looked at for interim analysis, he did say that ~100 would be included in the DSMC review. That made sense, because on the date that he made that claim, we probably had ~100 subjects who had completed the 28 days.

2. On at least 2 or 3 occasions, Dr.NP claimed that the DSMC could terminate the S/C trial due to overwhelming benefit -- and that's specifically why CytoDyn was asking for the review. Now, I suppose the DSMC could have limited the scope of their review to ONLY the safety of the treatment and placebo arms, and arrived at the conclusion that an inordinate number of placebo subjects were dying (which is technically recorded as a SAE). If that were the case, I am assuming the DSMC could recommend terminating the trial for overwhelming benefit. But I'm not actually sure how death (as reported as a SAE) is really any different from Day 28 Mortality (or Day-14 Mortality which is a SE). Although, you could certainly have drug-related AEs and SAEs.

3. Given the fact that we had 120 subjects enrolled on July 3, and 28 days later was July 31, and the DSMC met on August 3 -- I would say the only way the DSMC could have looked 149 subjects is if they looked at Day-28 and Day-14 -- or if they looked at ALL of the subjects in the treatment arm that were signed-off, locked and transmitted to the DSMC in advance of their meeting.

4. There may be a reasonable explanation for why a DSMC review that was described by the company as being initiated for the sole purpose of potentially terminating the trial due to overwhelming efficacy -- was later described as only looking at the safety of leronlimab. The company may not have had the ability to ask the DSMC to look at efficacy, so they chose the only option available to them -- that being safety. The fact is, the DSMC probably only had between 100-120 Day-28 subjects to review in order to make that determination. That number may have been too small, there may not have been enough deaths in the placebo arm -- or as a group, the DSMC may have determined that increasing a "trending" statistical significance to yet a lower P-value made more sense given the 30-odd more days it would take to provide the FDA with an irrefutable result (interim at 195).

Hard to know, but also largely irrelevant at this point. We didn't get a termination, but the company framed it as best as they could.

Hopefully, CytoDyn has provided the FDA with not only the stellar M/M safety results -- but also bolstered them with the stellar Combo HIV, Mono HIV, and COVID eIND data -- and lastly, the DSMC's safety review of the S/C. Taken as a whole, it creates a very well supported thesis that leronlimab is incredibly safe.