What the FDA is saying is those holds are gone, bu

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What the FDA is saying is those holds are gone, but there is a full hold on LL

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A hold across all indications would be due to safety or manufacturing concerns. The safety hold for leronlimab was lifted. Any other hold is per indication and a proposed protocol would need to be submitted in order for the FDA to determine if a hold is warranted for that indication. So the hold must be a full hold only on immune activation in HIV. So any other protocol could be submitted and judged on it's own merits.

CFR - Code of Federal Regulations Title 21

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Numbers from this new protocol are not aimed at getting approval for any specific indication and harm their relationship with any BP firm.

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The data from the proposed trial will be the basis for a phase 3 trial and getting an approval specifically for quelling overactive immune systems in HIV patients. The implications of that data are even broader and will apply to every other protocol we submit for any disease. The FDA may not believe now that leronlimab can do what it does but they won't be able to refute scientific evidence. If their goal was to protect BP then allowing any trial for leronlimab that shows the broad reach of cytokine suppression and specific immune activation would be a fail.