The PR states: “The Company is very excited a
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“The Company is very excited about these results and is concurrently working with regulators here and abroad to expedite leronlimab’s approval to treat COVID-19“
Working on an expedited approval with regulators for COVID-19, I like the sound of that. I don’t think these agencies would allow the above to be in a PR if it weren’t true. Idk for sure but that’s my thought.
It sounds like things are well underway and that part of the last two weeks were used to design the “additional protocol” and discuss an enrollment strategy to collect this other data. EUA is probably a little further than we thought, however assuming LL continues to block CCR5 tomorrow there is a very (very) high probability EUA is coming
Merck ditched its vaccine programs to concentrate on its therapeutics. The oncoimmune buyout molecule just got denied EUA end of Feb, and they are going forward still. If Merck thinks it’s still worth pursuing COVID therapeutics, so do I. Merck’s manufacturing is also not in as good of a place as ours.
Lastly our regulatory discussions are also “on-going” per the PR, I see some hand holding going on from the FDA and I like it. I don’t think they put resources into such things that don’t show signs of likely approval.