I'll take a stab.Quote:PR after the market closes today or pre-market tomorrow? Thoughts?
CytoDyn might hope to learn the disposition of the M/M COVID EUA in today's call, but that doesn't mean they will.
I also don't know if the team they will be talking to regarding the Multidisciplinary Review of the Combo HIV filing is even affiliated with the group reviewing the M/M COVID EUA application.
More likely in my mind is that they gently remind the FDA that discussions commence tomorrow with the UK MHRA regarding Fast Track approval and the path to market for the M/M COVID indication.
If CytoDyn does receive formal written FDA approval, the clock will start regarding the 4 (four) business days they have before they must disclose a material event, as mandated by the SEC.
Judging from information posted by some experienced pharma board members (which I can't find at the moment) there are many complicated details that need to be discussed and finalized before an approval is announced (e.g.: labels, warnings, distribution, and more). Since those discussions have likely not taken place, I doubt either party is in a position to PR an approval.
I have also observed that PRs relating to FDA approvals are coordinated between the FDA and the company, with both seemingly released on the same day. So I doubt CytoDyn would go rogue and make an announcement without the coordination and blessing of the FDA.
Lastly, if it were me, I would not announce a FDA approval before having my meeting with the UK MHRA. In spite of the fact that those two agencies talk to each other, I would want to negotiate and acquire Fast Track approval and make progress with the path to market discussion -- without the overlay of the US demanding CytoDyn's entire inventory of leronlimab.
So, long-story-short -- I would be very surprised to see a PR announcing FDA approval after market closes today -- or pre-market tomorrow. If leronlimab has even been approved at this time, which is doubtful in my mind, I wouldn't expect a PR until the end of the week, and more likely by Monday or Tuesday of next week.
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