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Re: Astavakra post# 138683

Friday, 01/29/2016 4:56:05 PM

Friday, January 29, 2016 4:56:05 PM

Post# of 403079
Not sure about the grammar, but that is a very direct change in language regarding K efficacy. Prior to today, any mention of continuing treatment was couched in the qualifier "perceived benefit." Today we read "unethical" to continue if it does not help patients.

Grammatically "may help" is mandatory because if one recalls only about 50% of the enrolled patients responded to treatment with increased p21. So, another way of interpreting this is there is evidence it helps some patients and that is what they are examining in the expanded trial.

Recruiting is closed, so my interpretation is some patients are continuing cycles and there will be some tweak in the protocol allowing some "experiment." This could range from combining treatments to increasing the frequency of dosing. Someone mentioned Phase 1/2 extension, and increasing frequency would be an optimization step. But, only DF and CTIX know what it all means.

They serve beer Popsicles?

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