The scalawag (Cyder) just won't stop. No need to h
Post# of 148101
His message and my replies -
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cytodyn still under yet another regime still can't properly present info in a PR. and you LOLngs still can't decipher anything.
"A larger study would drop Resmetirom below .05."
> resmetirom didn't have a .05. leronlimab had a .05 in the comparison to resmetirom.
I have to assume that either English is not your primary language or your lack of comprehension is exceedingly bad. You cannot parse that leronlimab - p = .01 and Resmetirom - p = .057? It's a comparison of the actual results from the trial not a percentage of what leronlimab did vs what Resmetirom did.
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Leronlimab monotherapy (700 mg) demonstrated statistically significant fibrosis reversal compared to an isotype IgG4 control arm (p<0.01)
Leronlimab monotherapy (700 mg) appears to have better anti-fibrotic activity compared to Resmetirom (p=0.057).
https://www.cytodyn.com/newsroom/press-releas...y-with-smc
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"With our phase 2 already done and supporting evidence for mechanism of action and dosage from this study we are set to go directly to a phase 3 trial."
> a tiny exploratory with conflicting results and then mouse studies showing something different is not even close to being enough to go to phase 3. and lalezari wouldn't be that stupid anyway. you need a better idea of the performance of the drug and the design necessary to succeed b4 you attempt p3.
The phase 2 trial was statistically significant with both endpoints and could have proceeded to a phase 3 based on that alone. The study was done to elucidate the discrepancy in 700mg dosing and further bolster the mechanism of action in MASH. If it wasn't done then the FDA may have stuck us with a 350mg only dose rather than a 350mg/700mg dose escalation. Which shows management is doing things correctly.
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really doesn;t matter as there isn;t going to be a clinical trial of leronlimab for MASH. again, lalezari isn;t stupid. this mouse study ended the development of leronlimab in MASH. there are at least TEN companies out there with p2 fibrosis reduction as well as fatty reduction. they are years ahead and have better data.
So tell me what companies have shown better results in a trial as small as our phase 2 where they used a suboptimal dose.
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"If the trial is for early stage MASH than it would be leronlimab vs. standard of care (Resmetirom). If it was later stage than it would be leronlimab vs. placebo because Resmetirom is not approved for later stages."
> what on earth are you talking about. lol so resmetirom is approved for f2 f3. nearly every single mash trial is for p2 p3. leronlimab only has data... so so so scant... for f2 f3 only. not sure what you think late stage MASH is. tf4 are cirrhosis trials not mash.
Cirrhosis caused by MASH is the F4 level of MASH so yes indeed it's still MASH. Personally I'd like to see an F2 through F4 trial for leronlimab stratified by level since everyone else seems to be afraid to do F4.