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Posted On: 03/08/2021 2:08:57 PM
Post# of 148902
“And, who the **** is advising NP to not file a formal EUA application, not merely here, but M2M previously, is that the CRO, too?”
NP stated that he asked the FDA to review the M2M data and advise CYDY if the data was good enough for EUA. NP said the FDA said not to EUA and that a larger phase 3 trial would be needed if EUA or approval
NP said in the Dr. Been interview that the FDA denied EUA for the CD10 because the endpoints were not statistically significant.
There’s no reason to spend the time and money to submit an EUA if the FDA has advised against it. But I believe it’s a mix of NP and Amarex that is the issue.
NP stated that he asked the FDA to review the M2M data and advise CYDY if the data was good enough for EUA. NP said the FDA said not to EUA and that a larger phase 3 trial would be needed if EUA or approval
NP said in the Dr. Been interview that the FDA denied EUA for the CD10 because the endpoints were not statistically significant.
There’s no reason to spend the time and money to submit an EUA if the FDA has advised against it. But I believe it’s a mix of NP and Amarex that is the issue.
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