There is a pre-IND meeting that needs to happen before the IND submission is made.
During this meeting the board will get a good idea of what the likely outcome of the submission will be.
It is also a chance for them to get a better understanding of what the FDA will want to see in the submission.
I don't think the pre-IND meeting has happened yet.
If the FDA give the green light on the NFL player trial, chances are good they will grant the Phase 3 trial for OA.
TGA here in Australia will likely reach the same outcome, but not a given.
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There is a pre-IND meeting that needs to happen before the IND...
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