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I suppose that's possible. However, the only "agen

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Post# of 155294
(Total Views: 718)
Posted On: 10/19/2020 8:01:57 PM
Posted By: MarcS
Re: blafarm #62035
Quote:
I suppose that's possible. However, the only "agency" we are currently aware of that is involved in this process is the FDA -- and they don't announce Halts, Approvals or EUAs -- those responsibilities are left to the sponsor company.


I don't think that is entirely true, at least as Approvals and EUAs. The FDA does in fact make announcements of drug approvals and EUA approvals. Maybe that is true of denials, but approvals are in fact announced by the FDA. I get those announcements all the time from the FDA. You think about it, that has to be true, because there has to be a list of approved drugs, and those approvals have to be announced in some manner by the regulatory agency. In fact, I learned of the Convalescent Plasma EUA by way of an FDA announcement shortly before Trump and his head FDA/NHS officials made the official public announcement. The FDA teed up the Trump CP press conference for him.
I admit that I am reaching to conclude the FDA may announce something at 4 pm, with CytoDyn at 5 pm, but it is a remote possibility. There is a reason for the delay, but I just don't know what it is.
Quote:
However, a one hour delay is not very significant -- a one day delay would be a completely different animal. For example, a one hour delay could be explained by a scheduling conflict with one of the participants, or the need to spend more time on the slidedeck that is being presented during the meeting.


It would not be the CC that got bumped if there was a scheduling conflict, but the other meeting, unless of course it was a meeting with the FDA or similar agency.


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