(Total Views: 566)
Posted On: 01/19/2020 2:10:14 AM
Post# of 153887
Quote:
Yeah, I agree, fast approval with cancer could save lives, but 15K people died with AIDS in the US last year while the FDA decided on 500mg or 725mg for leronlimab, even though there hasn't been one SAE in 15 years of trials with HIV. Getting BTD would help improve that speed with cancer approval tremendously, though even with BTD I personally doubt approval will happen in 2020, we will see what the FDA says.
I have never expected cancer approval in 2020. H1/2021 would be tremendously quick. I would be happy to get HIV Approval in H1/2020 which is not guaranteed.
Regarding HIV, I am a bit puzzled as there was still "525 or 700mg" on Nader´s transparencies at JPM Conference presentation. That would tell me that there is still no final decision being taken by FDA about dose which would then mean that BLA would take another few more weeks....
I love the cancer talk, but I would love it a lot more to see the long promised progress in HIV.
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