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Re: grizzlyman post# 130402

Monday, 11/16/2015 7:23:10 PM

Monday, November 16, 2015 7:23:10 PM

Post# of 403036
I guess we'll have to wait for the trial design to be announced, however biodoc is correct that the 750mg/m2 dose in Phase I would be considered larger than the efficacy in the mice studies. The FDA guidance document from FDA.gov lists the conversion number for mg/kg to mg/m2 in mice at 3 ( 200mg/kg = 600mg/m2 for mice). They also list Human Equivalent Dose (HED) conversions, Mouse to HED for mg/kg is 0.08 so 200mg/kg mouse is 16mg/kg human. Converting 16mg/kg human back to mg/m2 is 592mg/m2 human, as compared to the 750mg/m2 dose in the Phase I.

Take this all as estimates, but numbers are from the FDA's 'Guidance for Industry' document.

When mathematics and data are used in prediction we call this an 'educated guess'.

So, for those that might think I am daydreaming at $800 CTIX, please at least agree to call it 'educated daydreaming'.

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