Yes, the intention will be for a registrational trial.
Steven has obviously decided not to go headlining this in an official ASX release, erring on the side of reserved expectations .
It's not Professor Miles Princes role either to go flagging any possibilities of a registrational trial.
However Steven has mentioned multiple times that it is his objective to push the FDA for a registrational trial for PTX-100.
I think Steven will be having very serious conversation right now with the FDA for designing the next phases framework around a registrational trial. With orphan drug status already granted by the FDA, excellent safety profile, fantastic responses beyond SOC currently available...Why should we not be optimistic for the FDA to grant a registrational trial?
Given the unmet need and proven safety profile of PTX-100, it appears to me the risk for the FDA is not approving the registrational trial.
We wait and watch for the FDA decision in the new year.
Excellent work team PTX.
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