@dansfera: The FDA Complete Response Letter dropped *zero* red flags on efficacy across 967 patient administrations. More surprising? Not a single question regarding safety, explaining why the AdCom meeting never materialized. That's huge, considering the lack of concern raised about blood pressure data, despite the compound's known cardiovascular profile. This data point alone flips the script on the current narrative. A massive oversight for those betting against this one. #FDA #Biotech #PharmaNews #Investing #DrugApproval