sounds interesting. but from what i know with my other investments regarding FDA, they would have to hold meetings with them first and clarify the conditions for any approvals from them.
So after internally reviewing their data and confirming that it is "FDA suitable", they should request for a clarification meeting with the FDA.
But this should be initiated asap and not only at the end of the trials.
Even without the FDA, getting it approved in Australia only would be amazing, which could then still be the door opener for the two biggest markets (EMA and FDA)
Ann: Update on Phase I/II Clinical Trial for Burn Wound Infection, page-96
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