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Re: sab63090 post# 36483

Sunday, 03/28/2021 10:00:45 PM

Sunday, March 28, 2021 10:00:45 PM

Post# of 43784

Heavy dropouts would have caused the trial to be stopped a long time ago.



I was not considering that the trial would have been stopped but one of the analysts who evaluated the trial, came out with the conclusion that it probably will be successful, nevertheless suggested that the trial could fail in the unlikely event that 30+% of the trial were LTFU.

I did not consider that with an excess of LTFU, the trial would be stopped. Instead I was guessing that to a large extent those LTFU would have been replaced by additional patients. This of course would have caused an even further delay of the trial.

In the absence of any LTFU and a 37.5% event rate (298/795 patients) I would imagine that SOC would have at least a 50% event rate and hence Treatment's event rate would be around 25% (50%+25%/2=37.5%).

I do expect this rosy outcome to be modified by a modest number of LTFU which would still show Treatment to be much superior.

Finally, while the free SOC treatment in this trial is a big incentive for staying in the trial, many of those patients most likely become very desperate when there condition becomes much worse. In that case, if they have some financial means, some of them in a desperate attempt to save their lives would switch to another even expensive treatment that they imagine will be better but could very well be even less effective. Among the more than 50% of SOC patients who succumb within 5 years, there probably will be a some who will opt to sacrifice their money for the hope of staying alive.



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