(1) FDA is very satisfied with our phase 2 m-m res

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Posted On: 09/13/2020 12:50:04 PM

Posted By: blafarm

Re: Heads #55577

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(1) FDA is very satisfied with our phase 2 m-m results (so no P3 is required);

My guess is that they spent time trying to wrap their heads around our incredible SAE. I don't know if they wrestled with NEWS2 not being their invention, they certainly seem dysfunctional enough. But I agree, it would be impossible for them to not conclude that we have something special. And I also agree, it seems long past the time where they would ask for a Phase 3.

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(2) FDA and NP are concerned about prompt acceptance by the medical community and by the public at large because: (a) previous FDA covid-related therapeutic mistakes and missteps, (b) only a phase 2 was done for Leronlimab, and (3) less than 100 patients tested in phase 2;

I think you are correct on all counts, with the possible exception that I'm not quite sure the FDA has shared their complete thinking on the subject with NP.

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(3) FDA and NP are very confident about upcoming P3 results for severe to critical;

I'd like to think this is true. The FDA strikes me as being the "show me" agency, and they haven't expressed confidence in anything we have ever done.

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(4) Because of their confidence in P3, FDA and NP agree that the best course of action is to wait for the P3 data, thereby making available great safety (and efficacy) data for a thousand patients (ie. HIV patients, covid P2 trial patients, covid P3 trial patients);

I agree, but again with the possible exception that I'm not sure the FDA has read-in NP.

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(5) Leronlimab receives simultaneous EUAs (or perhaps full FDA approvals) for any and all covid patients, once P3 data becomes available;

I agree.

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(6) MHRA - see and apply 1 through 5 above.

This is where I possibly deviate the most from your thinking. I think the UK MHRA possibly approves the M/M CD10 before the CD12 interim readout. And the reason they do that is because they are extremely comfortable with NEWS2, and by approving quickly they jump the line that every other ex-US nations will be standing in, because the US is likely going to buy all available leronlimab inventory when the CD12 meets its endpoint.