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TheHound

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Re: georgejjl post# 79360

Monday, 11/24/2014 8:59:01 AM

Monday, November 24, 2014 8:59:01 AM

Post# of 403123
BK is not wrong. This method is used as a conversion between animals and humans for estimating the maximum safe starting dose not efficacy.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm078932.pdf

Dr Menon stated the human efficacy range was expected to be between 100 and 200 mg/m2. The current cohort is almost double the top of that range. What efficacy end points for secondary outcomes do you think the staff at DF are seeing?

As always, in my opinion only. Do your own due diligence!

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