At one point FDA Janet Woodcock says: "Very soon we should open up the monoclonal antibodies to direct ordering so they can be ordered by anyone who has capacity to administer them."
It's possible it was referring to the IV monoclonals, but the comment is suspiciously similar to how leronlimab would be ordered.
Also says: "have a very good pipeline" of monoclonals.
She says that hundreds of repurposed drugs are being studied for Covid-19 treatment.
For the inflammatory stage, immunomodulatory agents. Doesn't that sound like leronlimab?
But, she did say that for therapeutic agents, only 5% of trial arms give us an answer that is actionable. But, because they are talking to and negotiating with the FDA, isn't is likely leronlimab is within that 5%?