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trding

10/17/17 2:22 PM

#17730 RE: fred198484 #17728

Thanks Fred, since they enrolled exactly 40, they may have been using the first Phase III of Ibalizumab as a guide. I didn't look closely and just went to the last trial assuming that was it. Since you are familiar with both trials, any guess as to why they only required 40 for Ibalizumab, but 50 for Pro 140? I also assume they only used those 40 for safety data as well for Ibalizumab, since it had no big mono trial? The 300 safety data vs possibly 40, I see is a much bigger requirement. That 300 safety data number is really what is delaying the BLA.