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Re: Cyosol post# 7849

Wednesday, 01/16/2019 1:17:48 PM

Wednesday, January 16, 2019 1:17:48 PM

Post# of 21544

Patience is key. Time is on our side.



Indeed it is.

The previous study already had a p value of 0.012 for the subgroup. I don't think many understand how big deal it was to get such a low value with only a handful of patients. It was possible because of great effect size never seen before.

With current ongoing study they are probably going to get p value close to 0.001 with similar effect size. That makes it a slam dunk on efficacy and safety is already mostly proven.

So as you said, time is on our side.

And as Dr Alkon has said, if they reproduce previous results there's a good chance that FDA will give them accelerated approval to start treating some patient groups. IMO it could mean that while they have phase 3 ongoing they are able to already start treating patient population that is not eligible to participate on the study.
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