RE: Project Frontrunner16 Jul 2024 13:01
Jalkanen shared that the FDA’s guidance will accelerate trials, potentially bringing new treatments to the market sooner.
He explained, “We went with a humble attitude to the FDA, proposing a Phase III trial for relapsed refractory MDS. The big news is that the FDA recommended going directly into a frontline MDS study, opening up a much larger market sooner than anticipated.”
This acceleration not only speeds up the process but also targets a larger patient population without significantly increasing trial costs.
Jalkanen also highlighted the importance of the Frontrunner program, which promises to bring treatments to patients faster in areas of high unmet need. The feedback from the FDA will significantly impact their commercial forecasts and development plans for BEXMAB.
Faron Pharmaceuticals will continue with Phase II trials as planned,