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I’m trying to remember the sequence of events fo

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Post# of 153903
(Total Views: 518)
Posted On: 07/07/2021 7:29:00 AM
Posted By: gestalt2
I’m trying to remember the sequence of events for the combo/ mono trial history. If I recall, the combo trial was done by the time Bruce came on board and the receptor occupancy test was only for the mono trial. This is where I’m confused, the only data used for the combo trial from mono was the safety data. At some point receptor occupancy was needed for the mono trial after the fact and incell was able to do that, was it that the fda then wanted receptor occupancy for the combo trial? Is it when receptor occupancy from the mono was presented that the fda had a problem with that data?

It seems that Nader and Bruce could give a clear explanation for what happened. My guess is that the fda wanted receptor occupancy after the fact for combo, but Nader is not interested in saying anything negative about the fda and Bruce is not interested in revealing any responsibility in the ultimate rtf.


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