Some were guaranteeing resubmission and approvals do to the RTF? SMH at that one. Clearly an incorrect assessment.
HIV is missing in action. The logically “ closest indication “ for approvals ( as we have a trial that hit endpoints on combo HIV) is mysteriously oh so far away…why???
Hysterically low bar for NP and company that champagne corks are popped for “ enrollment in a trial “. There is a long road ahead and certainly no guarantees that trials were designed properly this time.
The HIV resubmission has been clearly botched and apparently put on the back burner. There is no evidence to suggest Naders MOA has changed. Do it fast, do it cheap ( except for lawsuits) and do it over and over.