I may not have been clear in terms of articulating my concern.Quote:Also, we likely will not have enough inventory for all these indications in a couple weeks so the BLA timeline might not matter much, unfortunately
While I'm not especially happy with the 3+ month delay in getting the Combo HIV PDUFA date and (hopeful) subsequent approval -- it's not the end of the world.
And I agree that there will likely be no inventory for Vyera to sell for that indication anyway -- with Vyera's ultimate fate being an additional factor:
https://www.ftc.gov/news-events/press-release...inst-vyera
My concern sits squarely on two issues:
1. When is the FDA going to stop behavior that appears to be designed to delay our progress through their approval system?
2. This new and seemingly overreaching request for Mono data appears to be timed and designed to provide them with a mechanism to delay our COVID approval.
I will be happy to be proven wrong.
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