Since the agreement is technically rescinded I don't know how they could be held to a process. I would think a lawyer could make that case quite easily. Furthermore, the five-step process is ridiculous. Obviously this is been considered at the highest levels repeatedly. A multi step process only makes sense if there is new and independent thinking at each step. That is obviously not the case in this situation.
The only risk of not continuing this is if there is some prospect that tactically the FDA has decided to reject until the final level – accomplishing their goals of delay's yet not subjecting themselves to the ultimate wrath of Congress etc.
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