Can’t agree more - I hope I don’t come across as facetious in saying that it seems to indicate a lack of confidence on the part of the FDA in their own ability to fully grasp or back their own judgment.
Having worked in a financial regulatory environment, I think I understand how the hierarchy of data, information, insights and judgment works. There seems to be a lot of hand wringing about the data, perhaps because there is a reluctance to make an upward migration to making a call. The ODAC experts, being experts with experience under their belts, made a different call early on.
Hence the frustrating delay.
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