Maybe that is why they chose the current path, as we are not reliant on the FDA for anything at the moment. Even though we have the fast track designation it is not yet relevant to current trials and no clearance required from FDA.
I think they plan to go to FDA further down the track once phase 1 completed at least.
one would hope worst case is HREC might just ask for more data. Even that would be bad though. Hopefully just straight go ahead for trial. It was apparently the teaching hospital that pushed for a trial in this area so hopefully they put in a good word.
Maybe that is why they chose the current path, as we are not...
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