Cdiddy, "I maintain my belief that the recommen
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Posted On: 02/24/2021 2:44:39 PM
Cdiddy,
"I maintain my belief that the recommendation to look at 42 day mortality at 28 days was to possibly help obtain a p value of .005 (2 zeroes) so as to halt the trial at 75% enrollment."
Yes, I agree, but logically, the DSMC must have already seen some of the deaths occurred beyond 28 days to even think about making the recommendation. At 50% interim, NP reported 45 deaths. Again, these are SAE's and unknown if it includes deaths beyond 28 days. I say there must have been because the DSMC noticed enough to recommend 42 days.
"The argument that we may have only had 67 deaths inside of 28 days actually strengthens Leronlimabs efficacy projection, if we assume that there was 30% mortally in placebo, INSIDE of 28 days."
I think SOC has improved greatly and the placebo mortality might be more like 20-25%. But with the overall mortality of 67/394=17%, then yes LL does still show overall improvement vs placebo but is the number of deaths enough to allow stat significance? I don't know. I do feel strongly that we could easily get there if we were able to include the 42 day data which will cover all the 87 deaths (and few remaining additional that were yet to reach the full timeline).
Again all my opinion & conjecture based the MESO trial failure and now the RLFTF PR. It seems the 28d end point was chosen because it's typical and it reminded me of CD10 where they chose TSS as PE because that was typical for flu trials.
Read More: https://investorshangout.com/post/newpost/605...z6nQ2P6TtT
Read More: https://investorshangout.com/post/newpost/605...z6nQ0zLrWT
"I maintain my belief that the recommendation to look at 42 day mortality at 28 days was to possibly help obtain a p value of .005 (2 zeroes) so as to halt the trial at 75% enrollment."
Yes, I agree, but logically, the DSMC must have already seen some of the deaths occurred beyond 28 days to even think about making the recommendation. At 50% interim, NP reported 45 deaths. Again, these are SAE's and unknown if it includes deaths beyond 28 days. I say there must have been because the DSMC noticed enough to recommend 42 days.
"The argument that we may have only had 67 deaths inside of 28 days actually strengthens Leronlimabs efficacy projection, if we assume that there was 30% mortally in placebo, INSIDE of 28 days."
I think SOC has improved greatly and the placebo mortality might be more like 20-25%. But with the overall mortality of 67/394=17%, then yes LL does still show overall improvement vs placebo but is the number of deaths enough to allow stat significance? I don't know. I do feel strongly that we could easily get there if we were able to include the 42 day data which will cover all the 87 deaths (and few remaining additional that were yet to reach the full timeline).
Again all my opinion & conjecture based the MESO trial failure and now the RLFTF PR. It seems the 28d end point was chosen because it's typical and it reminded me of CD10 where they chose TSS as PE because that was typical for flu trials.
Read More: https://investorshangout.com/post/newpost/605...z6nQ2P6TtT
Read More: https://investorshangout.com/post/newpost/605...z6nQ0zLrWT
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