“The inference during the last call was that FDA
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Posted On: 05/28/2020 4:13:53 PM
“The inference during the last call was that FDA wants to give us approval.”
Personally, I didn’t infer this from the most recent CC, but we all interpret information differently. Are you referring to NP repeating 5 times that CYDY could end the mild/mod trial after data from 50 patients and submit the data to the FDA? I’ll admit, I don’t understand why he kept repeating it over and over.
But would the FDA tell CYDY, “Hey, based on the EIND data, take a peak at 50 and we might approve you if results are consistent with the EINd patients?” Seems unlikely, but then again HCQ and REM were both approved.
Personally, I didn’t infer this from the most recent CC, but we all interpret information differently. Are you referring to NP repeating 5 times that CYDY could end the mild/mod trial after data from 50 patients and submit the data to the FDA? I’ll admit, I don’t understand why he kept repeating it over and over.
But would the FDA tell CYDY, “Hey, based on the EIND data, take a peak at 50 and we might approve you if results are consistent with the EINd patients?” Seems unlikely, but then again HCQ and REM were both approved.
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