“I think we are in the gray zone here because th
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Posted On: 04/18/2021 10:38:45 PM
“I think we are in the gray zone here because the FDA hasn’t flatout refused the EUA to date. If they did , it would require a press release stating the FDA has rejected the request because that is material information.”
Recall that CYDY filed for EUA with the data from CD10, the M2M trial. That EUA was denied by the FDA, but CYDY did not PR the denial. Instead, NP mentioned that the M2M would not get EUA after a question was asked during a CC. Therefore, I don’t expect a PR from CYDY announcing denial of the “conditional EUA” that NP says the company filed. The conditional EUA wasn’t mentioned during the last CC (it was not one of the 3 options that NP listed) so I’m assuming the FDA said no. I’ll submit a question during the next CC and see if NP gives a response.
Recall that CYDY filed for EUA with the data from CD10, the M2M trial. That EUA was denied by the FDA, but CYDY did not PR the denial. Instead, NP mentioned that the M2M would not get EUA after a question was asked during a CC. Therefore, I don’t expect a PR from CYDY announcing denial of the “conditional EUA” that NP says the company filed. The conditional EUA wasn’t mentioned during the last CC (it was not one of the 3 options that NP listed) so I’m assuming the FDA said no. I’ll submit a question during the next CC and see if NP gives a response.
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(1)CytoDyn Inc (CYDY) Stock Research Links
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