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Posted On: 11/20/2020 11:38:46 AM
Post# of 149994
“New CSO Rahman needs to get CYDY to immediately file a request for EUA for M2M with the FDA. Screw it that the FDA said not to, just file it.”
Bad idea. NP hinted that he didn’t file the EUA for the M2M population because he didn’t want another “strike” against CYDY from the FDA. That tells me the FDA felt strongly that EUA wasn’t an option and that CYDY may not be viewed as having a positive standing with the FDA after the 2 patient cancer BTD, the HIV RTF, and the 70+ COVID EINDs (these were good for patients but the FDA appeared overwhelmed with that many EINDs).
Filing an EUA for M2M after the FDA specifically reviewed the findings and recommended against an EUA would only make CYDYs standing with the FDA worse. We don’t need that.
Bad idea. NP hinted that he didn’t file the EUA for the M2M population because he didn’t want another “strike” against CYDY from the FDA. That tells me the FDA felt strongly that EUA wasn’t an option and that CYDY may not be viewed as having a positive standing with the FDA after the 2 patient cancer BTD, the HIV RTF, and the 70+ COVID EINDs (these were good for patients but the FDA appeared overwhelmed with that many EINDs).
Filing an EUA for M2M after the FDA specifically reviewed the findings and recommended against an EUA would only make CYDYs standing with the FDA worse. We don’t need that.
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