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Re: jamesnhansen post# 36170

Sunday, 03/14/2021 5:47:46 PM

Sunday, March 14, 2021 5:47:46 PM

Post# of 43785
It is hard to imagine how this trial can fail.

Given a midpoint enrollment of 63 month, without dropouts (LTFU) in both arms and a lower than expected 50% death rate in the SOC arm, the Treatment arm will only have 25% of its patients dead at the end of the trial (an average of 37,5% death rate =298 patients in both arms).

Let us assume a worse case scenario where 47 of the 394 patients (roughly 12%) in each arm drop out during the first year after their enrollment (a highly unlikely occurrence). We are then left with 350 patients in each arm.

With 50% of the SOC arm or 175 of 350 patients (59%) dead after a midpoint enrollment of 63 months, we end up with only 123 of 350 Treatment patients (41%) who have succumbed during those 63 months
(175+123-298)

In my opinion this is a worse case scenario and the Treatment arm is still doing far better than SOC.

In reality I expect a somewhat higher attrition rate of about 55%-60% for the SOC arm, a lower than 12% dropout rate in both arms and therefore an even a better outcome for the Treatment group.









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