A couple of months delay is annoying but that’s all it is. I do worry though about the power of the FDA, and without knowing the exact questions, thus could be a delaying tactic. As others have mentioned it’s good to get the minutiae of the detail put to bed. I’m sure that all it is. The document by nature of its length has to be very thorough. In a perverse way maybe it’s too thorough as it could include details that may not have been needed? Like a lawyer preparing someone for deposition, dint say stuff you don’t need
Maybe that way off the mark. I do know I will be topping up as much as possible between now and the end of June.
The drug works. Just need to keep that in our heads
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