Balleroni, I'm not an expert, but my understanding
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Posted On: 01/29/2021 2:09:20 PM
Balleroni, I'm not an expert, but my understanding would differ.
I think we would need to see an IND w the FDA before Ph I, so I fully expect NOT to see any clinical testing info other than hopefully some more definitive time frames for the IND/trials.
The only thing I can think of that might change that is if Joe decided to proceed w some overseas testing with some party that would be willing to move forward and take FDA approval out of the equation. But Joe has previously indicated all of the deals would march thru the FDA, so I don't expect such a route.
Anyone please chime in if that is not correct...
I think we would need to see an IND w the FDA before Ph I, so I fully expect NOT to see any clinical testing info other than hopefully some more definitive time frames for the IND/trials.
The only thing I can think of that might change that is if Joe decided to proceed w some overseas testing with some party that would be willing to move forward and take FDA approval out of the equation. But Joe has previously indicated all of the deals would march thru the FDA, so I don't expect such a route.
Anyone please chime in if that is not correct...
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