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Re: macnqueso post# 43181

Monday, 10/07/2013 7:49:45 PM

Monday, October 07, 2013 7:49:45 PM

Post# of 403061
I have asked for both clarity on what signs of efficacy they are expecting between 100 and 200 and what the basis is for their figures.

They must be getting it from somewhere, but nothing that has been publicly disclosed as far as I can tell.

I would urge caution as to what to expect in terms of "efficacy". They may only be talking about p21 activation. Don't be expecting definitive signs of tumor delay until we are much higher. Possibly not until the Phase 1b escalation gets underway. We had assumed (as late as June) that our cohorts would be at least at 200 by now. At this point unfortunately we will be lucky to be finishing Cohort 9 at 300.

However, I continue to believe this stuff can be dosed at well above 500 safely and the 1b trial will prove that. We should be able to get close to 1000 based on the dog safety data.

"Efficacy" has an extremely ambiguous meaning. Hopefully Leo responds to some of my questions. Anyone know how long he normally takes to respond? I sent him the email Saturday.
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