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Tuesday, September 07, 2021 10:50:46 AM
They were not unblinded that was never the case and even if they were, having another employee draft it would not have changed that fact. But the fact is, they were NOT unblinded. And they said, before they hired Duffy how they were drafting and that they had numerous consultants involved and statisticians. There would be no reason why Bosch and Dr. Linda Liau (and UCLA team) and others would not be directly involved with both advising and drafting, though most likely the first drafts and document control might be with someone else specifically. Your speculation that they were unblinded at that point and hired Duffy from Merck to draft the SAP makes no sense. As I said, I would not be surprised if they consulted him. But he would not be the appropriate person to draft that document.
And no, I explained why he would not be the correct person. And there are plenty of other persons and consultants that they used for this purpose. He certainly was consulted, but I doubt he would be the correct person to draft such a sensitive and important document, given his various potential conflicts and being new to the company, the technology and not being a subject matter expert. His particular knowledge comes from Merck and other issues and challenges. He was there to advise (likely on structuring trials for a more general approval based on biomarkers) and do due diligence for another company most likely, regardless of the technical notion that they “paid his salary”.
I think your take on that point is not likely correct.
And no, I explained why he would not be the correct person. And there are plenty of other persons and consultants that they used for this purpose. He certainly was consulted, but I doubt he would be the correct person to draft such a sensitive and important document, given his various potential conflicts and being new to the company, the technology and not being a subject matter expert. His particular knowledge comes from Merck and other issues and challenges. He was there to advise (likely on structuring trials for a more general approval based on biomarkers) and do due diligence for another company most likely, regardless of the technical notion that they “paid his salary”.
I think your take on that point is not likely correct.
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