ASX/Media Release 17 July 2020 BTX 1503 End of Phase 2...

ASX/Media Release

17 July 2020

BTX 1503 End of Phase 2 Milestone with FDA

• Botanix achieves an important drug development milestone through completion of a successful End of Phase 2 meeting for BTX 1503 with the FDA

• Botanix has now confirmed a drug development plan to support registration of BTX 1503 for the treatment of moderate and severe acne

• Planning is now underway for Phase 3 clinical studies with the final outcomes informed by the completion of the BTX 1702 (rosacea) Phase 2 study and lifting of COVID-19 restrictions

Note the "Planning is now underway for Phase 3 clinical studies"

... and AFAIK that is all - no Phase III trial ready and cleared to begin.

... moreover it appears that Botanix wants a greater degree of monitoring, if not control, of the trial process and perhaps this is one reason why Phase III has been "underway" for a long time. After all, just as in politics where it is important who counts the votes, study of FDA trials during Covid19 suggests to me that control and monitoring of trial design, execution and analysis are of critical importance in determining the "result".