Most of the blame goes to the FDA, not to the messenger. BLA could have been submitted back in March/April last year with 350mg dose plus additional data submission after approval. Then FDA can't decide between 525 and 700mg, then they want more data from mono, than all data from mono. Ridiculous... An HIV crisis is there, institutions have vowed to combat that crisis and they delay an absolutely safe and highly efficacious HIV drug... Is this the trainee review team?
That cost us dozens of million of shares of dilution plus revenue for 5 months up-to-date...