Portola received approval for the Prior Approval Supplement (PAS) for the Gen 2 manufacturing process for AndexXa on the PDUFA date of December 31, 2018. Management had expressed confidence in approval but in dealing with the FDA, it is never over until it’s over. AndexXa was launched in June 2018 using the inefficient Gen 1 … Continue reading Portola: Approval of Gen 2 Manufacturing Process for AndexXa is a Significant Positive (PTLA, Buy, $18.75)