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scottsmith

10/15/15 8:56 AM

#125900 RE: To infinity and beyond! #125898

Are you saying before the P2 begins safety would have to be reproved? I don't think you are. Because that would suggest repeating P1.
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Waverunner1

10/15/15 10:06 AM

#125916 RE: To infinity and beyond! #125898

they will dose based on PK data and associated half life so that drug levels are consistent with those in the Phase I, just sustained for longer periods. No need to repeat safety in the context you are apparently referring to.


It will be good when ph 1 finally ends of course.

What about the next problem? The new protocols. Giving the drug 3-4 -5 x week at whatever dose? To what extent will safety have to be shown again?

We all hope that efficacy will be shown then, at more frequent doses, but will Kevetrin still have the same apparent lack of side effects? Will the new protocols require a much longer wait to prove safety, before the beginning of an ovarian ca trial, as one example, or can a trial start soon?

I do not know if Bologna and ovarian ca trials, and maybe pancreatic ca trials might see a start in 2016 or it'll be more like 2017/2018