Sunday, June 28, 2020 1:53:41 PM
1. S2C trial - it is interim analysis and all detailed analysis. Typical interim analysis is done to carry ‘futility’ and/or safety of the drug.
The safety is established so the focus will be to see if the trial is showing right amount of effects to continue and/or are we seeing dramatic results.
The primary outcome is - mortality at day 28 (secondary is mortality at day 14)
==> what if only 0 to 2 (out of 34) patients on Lero died as against 6 to 7 out of 17 placebo patients died? (This is my expectation)
Will it be considered dramatic enough to stop the trial?
As mortality is easy to find (patient died or not) and then how many left the hospital - I think the interim result may be declared by 6th Jul if it is as good.
2. M2M trial - this has one primary outcome and 12 secondary outcomes and 4 other outcomes.
Also this is final results and they have many other data points. So they will have to great job analyzing and presenting.
I expect these results to be good as well but this may take longer time - these results can go into Jul 20 week.
So my guess is - S2C critical interim results in week of Jul 6th and M2M results in week of Jul 26th
If S2C results are great, great going.
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