Wednesday, September 19, 2018 12:47:13 PM
They didn't have to have an end-of-phase 2 meeting before or simultaneous to the time of the BTD submission. The fact that the Company signed an agreement using it as a milestone on 6/28 suggests that it should have been submitted long ago.
The FDA either signs off on or rejects the submission. If rejected an explanation would have been provided along with how to fix it (if it's fixable). No meeting needed for BTD purposes based on the Protocol.
But can it core A apple?
Yes Ralph, of course it can core A apple.
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