RE: Big leak13 Aug 2020 13:34
From yesterday -Eton Pharmaceutical's second quarter results and looking very positive as say in regular discussions with FDA:
"Alkindi® Sprinkle Update
"Alkindi Sprinkle’s NDA is under review by the FDA for use as a replacement therapy for pediatric adrenal insufficiency. Eton and its development partner have been engaged in regular communication with the FDA, and Eton expects the FDA to meet the existing September 29, 2020 Prescription Drug User Fee Act (PDUFA) date without any disruption from COVID-19. Based on the communications received during the application’s ongoing review, Eton remains confident that the Alkindi Sprinkle application is approvable and is working aggressively on launch preparation activities. Eton has purchased initial commercial inventory and expects to be in position to launch the product shortly after the PDUFA date, if approved."