They already submitted some documents in September

They already submitted some documents in September.
They are aggregating the safety data across all the trials Amarex was involved in.

All hands on deck effort.
Recknor could not even be spared for the conference call as his hands were full.

Here, Cyrus shows how valuable this is:

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34:19: Christina: 7) How does Patterson's recent patent for CCR5 blocking in long covid 19 affect our efforts on that front and are we still applying for that NIH grant for long covid 19 research?

Cyrus: We have given our redefined Clinical developments focus which does not include Covid treatment in any setting, We don't see this as a concern to our business. Additionally, we do have other Covid related IPs that would protect leronlimab if we were to choose to do anything in that space in the near term. With regard to the NIH grant, our priority really is to complete our submission of all of our documentation for lifting the clinical hold before we would pursue any NIH opportunities for Covid.

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here is Cindy from YMB:

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@DJones it's being filed. they said so at the cc most likely the CSRs. they are working on aggregating the safety data. that needs to be done before you can submit a meaningful ISS ( or whatever is the biologics equivalent of an integrated summary of safety). the other big parts are the ISE (; integrated summary of efficacy). and the drug label language. the integrated, unblinded liver lab data could be of interest to the company and FDA - especially from that non-pivotal phase 3 mono therapy study because there's be no drug purposefully influencing the CYP3a4 levels and they could get a clean read on how leronlimab affects liver enzymes - either directly or wrt NASH.

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