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But it's item #2 that concerns me, as i have no confidence in the FDA trying to help us out.

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I really do think the FDA knows Leronlimab works and is safe, but they also do need the data (properly formatted, etc.). If we provide exactly what they ask, I don't believe they could justify continuing the hold when it's so clear this drug holds enormous promise. If Leronlimab becomes a famous, game changing drug down the road, the FDA's only excuse for holding it back could be they didn't have the right data. Mgmt is about to give them precisely that, so I'll be surprised if they want to prolong their sandbagging for much longer.

My prediction is hold lift by Halloween, worst-case Thanksgiving.