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Re: sunspotter post# 140375

Monday, 02/22/2016 10:41:52 AM

Monday, February 22, 2016 10:41:52 AM

Post# of 403170
I was wondering the same thing about which subjects they chose with "the greatest increase" (and why only look at those subjects), but I think they selected those subjects to make a point about the duration of effect, comparing p21 increase at 24 vs. 7 hours, and they needed subjects with a large p21 increase to make the point.

One could question several other things:

(1) why didn't everyone have an increase in p21 expression?
(2) why were some of the assay results uninterpretable (8 subjects)?

In any event, it's nice to see that on average, those with low dose K had a small p21 increase, and those with higher doses had a larger increase. As we had discussed before when statements were made about kevetrin having a dose-response for p21, it will be nice to see the raw data to see how reproducible the result is across subjects, and even within the same subject.

Then there's the whole question of does p21 increase correspond with clinical outcomes (as it appeared to do in animal model)? We have heard relatively nothing about clinical efficacy, except one of the last PRs says "suggestive evidence of the potential clinical benefit of" K.

Overall, this is a nice result. Maybe we'll see more details in a publication in preparation. We'll have to wait for Phase II to (hopefully) see efficacy.
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