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.
Yes, the intention will be for a registrational trial. Steven...
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