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09/22/16 6:44 PM

#6106 RE: gestalt2 #6102

I do not disagree. But I want to point out the criticism we received for our quantity of data came from a well known supporter of GILD. And while he is a PhD in this field his credibility is extremely questionable. There has even been a website made by an apparent group of activists to display his lack of integrity and ethics. Also, it appears as though the FDA has different requirements for MAB's than ARV's. And in my opinion they should. The two are apples and oranges. Yea their both fruit but they're definitely not the same. And we have to remember, this is a new frontier for the infectious disease field. Industry standard for ARV's may not end up being the same for MAB's. That being said, I am almost never opposed to running a better designed trial. I do agree that we could see some benefit from a 150 patient trial vs a smaller number. We will see what happens. And good point. Thanks for bringing that up.