RE: Today9 Apr 2022 10:53
From July 2021
PRO finished, discussions ongoing with FDA, protocol power size calculated (given magnitude of effect, other phase III studies and real world experience doesn’t have to be large) sites identified, drug supply available, data now in Hispanics and African Americans, market size analysis and price point sensitivity re-done by top tier US marketing organisation, licensing partners have access to data room and have been updated. Play out over the next 12-18 months.