Ann: Presentation of BIT225-009 HIV-1 Phase 2 Data, page-588

I think it didn't statistically reduce mortality, not that it had zero effect which is a numbers problem. Sure the results might not have been what they were hoping for when they designed the trial, but they now have something they can get approval.

I don't think the additional cost will be an issue (in the USA at least), it will come down to do the doctors think the treatment is worth using to reduce intestinal bleeding. My guess is they will given how much of a problem it is in the LVAD patient population, but ultimately we will only know when it is on the market.