This exactly his word to word comment on the question regarding RCT in ODAC.
Dr. Hinrichs- Am stressed by the randomized trials and finds them compelling negative. I realized that there been changes in the manufacturing at this point but I don't think they are entirely irrelevant and he goes again to the question of whether from the single ARM study we are convinced that this has efficacy. And I do think that two prior randomized trials convincingly showed that the other product at least in the population that is being studied which is similar or not the same, clearly did not have any more liberty. So do we think that these tweaks to the manufacturing have only made it highly effective and we're taking popular highly effective?
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