Agreed; this is for people with AIDS with limited

Agreed; this is for people with AIDS with limited options, with clean safety data for 14 years now. At some point it is just ridiculous. I would hate for my life to be in need of something that the FDA must approve. Now the mTNBC estimation being wrong I put most the blame on CYDY, most likely RP overestimation and NP going with it. But the BLA delay, all on FDA. Even the trial which took years, all on the FDA also. Even with results better than maraviroc, the FDA still thought they should wait 6 months to get the 700mg (since 700mg did so much better than 350 in mono). They are on a completely different clock. Also, they pushed leronlimab down the unmet need path first, while other injectables bypassed that part.

I really think the biggest reason we are here, and why cydy owns leronlimab to begin with. In the phase 1 trial, 15 years ago, before cydy had pro 140, they got great safety results, but didn't decide to try anything above 350mg. Many in phase 1 in the 3+3, will add new levels if the everything comes back good. Instead we learned about it in the mono phase 3 investigatory trial almost 14 years after we should have. If they would have pushed in up to 700mg back then, they would have gotten great phase 2 data, and it would have been pushed for approval back then (without CYDY's involvement).