same same but different story, ILA designed a trial for a reformulated drug and wanted to enter the market at P2B. FDA said no, and they had to started with a dose escalation study, e.g. start with a phase 1.
It was using the drug for a different indication, but still no guarantee with the FDA. BOT rejected based on labelling, MSB rejected based off evidence. Few examples out there where companies thought they were set but were turned away
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