ClosetInvestor, Changing SOC conditions do affe
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Posted On: 12/23/2020 11:05:59 AM
Re: ClosetInvestor #69394
ClosetInvestor,
Changing SOC conditions do affect trials outcomes as it is more difficult to stablish contrast between the cohorts. Basically one can say that the "placebo" arm reduces the number of deaths.
However, Vyrologix is administered on top of whatever SOC:
As we have cojones to attempt death reduction (and the humongous prize at the end of the road) , our drug will likely improve the outcomes keeping the ratios. As a matter of fact, we know that we had a 27% death rate in the first half and this portion will be very determinant in the final outcome (as per the table of my last post).
For example: if we had 24/21 (Vyrologix/SOC) in the first half and then 12/8 in the second half (more proportional deaths in our arm in second half as compared with first half) resulting in 34/31 total we would have a 37.9% reduction of deaths (still statistically significant 0.0456 p-value).
What I am trying to say is that the first half is VERY determinant due to the high number of deaths. Of course, I do not know the split but is encouraging DSMC saw the potential to meet end points.
Mesoblast optimism came form their pilot study March-April at New York’s Mt Sinai Hospital where nine of 12 ventilator-dependent patients (75%) were successfully discharged from hospital with a median of 10 days after receiving two intravenous doses of remestemcel-L within five days.
Changing SOC conditions do affect trials outcomes as it is more difficult to stablish contrast between the cohorts. Basically one can say that the "placebo" arm reduces the number of deaths.
However, Vyrologix is administered on top of whatever SOC:
Quote:
Note: Subject who were prescribed (1) hydroxychloroquine or chloroquine with or without azithromycin, (2) Remdesivir, (3) convalescent plasma therapy, or (4) immunomodulatory treatments (including but not limited to sarilumab, clazakizumab, tocilizumab, and anakinra) for the off-label treatment of COVID-19 prior to study enrollment may be included and may continue to receive these agents as part of standard-of-care.
As we have cojones to attempt death reduction (and the humongous prize at the end of the road) , our drug will likely improve the outcomes keeping the ratios. As a matter of fact, we know that we had a 27% death rate in the first half and this portion will be very determinant in the final outcome (as per the table of my last post).
For example: if we had 24/21 (Vyrologix/SOC) in the first half and then 12/8 in the second half (more proportional deaths in our arm in second half as compared with first half) resulting in 34/31 total we would have a 37.9% reduction of deaths (still statistically significant 0.0456 p-value).
What I am trying to say is that the first half is VERY determinant due to the high number of deaths. Of course, I do not know the split but is encouraging DSMC saw the potential to meet end points.
Mesoblast optimism came form their pilot study March-April at New York’s Mt Sinai Hospital where nine of 12 ventilator-dependent patients (75%) were successfully discharged from hospital with a median of 10 days after receiving two intravenous doses of remestemcel-L within five days.
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