Replies to post #180242 on Cytodyn Inc (CYDY)

[justdafactss]

Brazil recruiting yet?

NOPE!

https://clinicaltrials.gov/ct2/results?cond=&term=leronlimab&cntry=&state=&city=&dist=

[stockorus]

Quoting from my post 163447 where I did some number analysis on pre 14 and post 14 days data for LL+SOC vs SOC alone.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=163593995

(Note I may have got the hard numbers by my own calculations at that time; so there is some difference (in SOC arm) from what was published - check. But they are close enough and the same analysis should apply.)


14-day mortality for the 62 critical patients

LL+SOC: 2 deaths out of 43 patients (4.65%)
SOC only: 5 deaths out of 19 patients (26.32%)

Mortality between Day 15 and 28

LL+SOC: 10 deaths out of remaining 41 patients. (24.39%)
SOC: 2 deaths out of remaining 14 patients (14.29%)

Leaving aside the question of insufficient trial size for the subgroup and looking just at the numbers:

Shorts: LL-arm fared worse after 14 days because it is no better than saline if not worse.

Long argument: LL's presence in body reduced and the treatment effectively became equivalent to SOC after day 14. Thus we find ~ 24% mortality in the second 14-day period when many of the patients who might have already died in the first 14-days if given only SOC ended up relapsing and dying during the second 14-day period after the effect of LL tapered off.

Recap:

SOC: Days 1-14: ~25% of critical patients died; Days 15-28: ~15% of patients still alive at start of Day 15 died by Day 28.

LL+SOC: Days 1-14: ~5% died. Days 15-28 (when effect was closer to just SOC): ~25% of remaining patients died by Day 28.

So apart from the 5% of patients, LL had arguably shifted the starting point for others by 14 days - after which they followed the SOC pattern. This shift may have been sufficient for some; but for the majority (of those for whom LL could have made the difference) not enough. Had the patients been given 2 more doses, they could perhaps have gained another 14 days to avoid lasting damage on the organs from the cytokine storm and for the body immune system to recover its balance.

[Ambersavage7194]

Leronlimab was given on day 1 and day 7…. Wearing off by day 14.

Didn't see your response before my reply, but stand by the these facts. Why test patients past when no drug was given, especially when MOA shows drug half-life is around 7-10 days tops. This half-life may be negatively skewed on Critical ICU patients as well do to absorption problems. Intravenous access is the key to ICU patients, as well as dosing during the entirety of the study.

Day 0-7 = Leronlimab vs Placebo
Day 8-28 = Placebo vs Placebo