Biodexa Announces Successful Outcome of a Type C Meeting with FDA Regarding the Phase 3 Program for eRapa in FAP Clears the ...

在其他近期新闻中，Biodexa Pharmaceuticals PLC已任命Precision for Medicine, ...

Biodexa Pharmaceuticals (BDRX) announced the results of its Type C meeting with the U.S. Food and Drug Administration, FDA, regarding the ...

Biodexa Pharmaceuticals announced a successful Type C meeting with the FDA, which has cleared the way to finalize the Phase 3 protocol for its drug eRapa in treating familial adenomatous polyposis ...

The Type C meeting followed a productive End of Phase 2 meeting with FDA and the publication of Phase 2 data of eRapa in FAP at six months at Digestive Disease Week in May 2024 and 12 months data ...

Biodexa Announces Successful Outcome of a Type C Meeting with FDA Regarding the Phase 3 Program for eRapa in FAP Clears the way to finalize Phase 3 protocol and recruit sites for U.S.

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February 10, 2025 Biodexa Receives US FDA Fast Track Designation for eRapa in Familial Adenomatous Polyposis Underscores unmet need for a therapeutic alternative with the potential to delay or ...

The U.S. component of the study will be conducted by LumaBridge, based in San Antonio, Texas. The planned registrational Phase 3 study of eRapa in FAP will be a double-blind placebo-controlled trial ...

The planned registrational Phase 3 study of eRapa in FAP will be a double-blind placebo-controlled trial in 168 patients, randomized 2:1 drug / placebo. It is expected the study will be conducted in ...