Yes, "zero" is a strong number, but the assumption
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Posted On: 08/28/2020 6:38:53 PM
Re: PennySlayer #52928
Yes, "zero" is a strong number, but the assumption is based on more than just the order or the bullet points.
The first bullet point indicates "current discussions" with the UK MHRA. That's an encouraging way to start the list because we can assume discussions are ongoing.
The second bullet point does not use the words "current" or "ongoing" discussions -- it uses "status". That implies to me that the status is known.
Now, I admit this sounds like I am mincing words in a way that is not unlike drawing a conclusion based on the order of a bullet-pointed list.
The SEC gives companies a maximum of 4 (four) business days to disclose material events. The outcome of the EUA is a material event. Friday + Monday + Tuesday + Wednesday = 4 Days.
If the EUA had been granted today, we would be talking about it right now. If the EUA had been rejected today, CytoDyn would have until Wednesday to disclose it.
I don't anticipate that the FDA is going to grant an EUA in the next couple of days, as CytoDyn could have just as easily waited a little longer to hold a 'victory lap' CC.
And, I doubt the FDA has told CytoDyn that they are going to grant an EUA on Wednesday morning -- so that CytoDyn could schedule a CC for Wednesday afternoon.
I also can't help but notice the familiar kitchen sink of other agenda items included in this PR. Talking about the HIV Cure Project, NASH Pipeline, Potential Other Trials, and Scientific Advisory Board seems like a misdirect and overcompensation designed to offset disappointing news.
The FDA has had weeks to review the CD10 results. In that time, they still found a way to approve convalescent plasma and remdesivir for moderate patients (today). However, it seems to me the FDA is kicking our EUA can down the road.
You're right, I would very much like to be wrong.
The first bullet point indicates "current discussions" with the UK MHRA. That's an encouraging way to start the list because we can assume discussions are ongoing.
The second bullet point does not use the words "current" or "ongoing" discussions -- it uses "status". That implies to me that the status is known.
Now, I admit this sounds like I am mincing words in a way that is not unlike drawing a conclusion based on the order of a bullet-pointed list.
The SEC gives companies a maximum of 4 (four) business days to disclose material events. The outcome of the EUA is a material event. Friday + Monday + Tuesday + Wednesday = 4 Days.
If the EUA had been granted today, we would be talking about it right now. If the EUA had been rejected today, CytoDyn would have until Wednesday to disclose it.
I don't anticipate that the FDA is going to grant an EUA in the next couple of days, as CytoDyn could have just as easily waited a little longer to hold a 'victory lap' CC.
And, I doubt the FDA has told CytoDyn that they are going to grant an EUA on Wednesday morning -- so that CytoDyn could schedule a CC for Wednesday afternoon.
I also can't help but notice the familiar kitchen sink of other agenda items included in this PR. Talking about the HIV Cure Project, NASH Pipeline, Potential Other Trials, and Scientific Advisory Board seems like a misdirect and overcompensation designed to offset disappointing news.
The FDA has had weeks to review the CD10 results. In that time, they still found a way to approve convalescent plasma and remdesivir for moderate patients (today). However, it seems to me the FDA is kicking our EUA can down the road.
You're right, I would very much like to be wrong.
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