“You can file a completely new and separate prot
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Posted On: 03/06/2021 10:55:53 AM
“You can file a completely new and separate protocol which they did. Again this is for full approval NOT EUA.”
Exactly my point. The possibility of EUA has already been reviewed and denied per the confidential discussions over the past 2 weeks. The new protocol is based on guidance from the FDA and not CYDY’s own brilliant minds who designed CD12 poorly, enrolled patients poorly, and skipped DSMC recommendations.
“This is what nobody seems to understand bc you most of you guys have never published. Personally I see an EUA coming early next wk but I guess we will find out shortly.”
I’m surprised someone who’s been published still believes EUA is possible based on non-stat sig data with an N of 62.
Exactly my point. The possibility of EUA has already been reviewed and denied per the confidential discussions over the past 2 weeks. The new protocol is based on guidance from the FDA and not CYDY’s own brilliant minds who designed CD12 poorly, enrolled patients poorly, and skipped DSMC recommendations.
“This is what nobody seems to understand bc you most of you guys have never published. Personally I see an EUA coming early next wk but I guess we will find out shortly.”
I’m surprised someone who’s been published still believes EUA is possible based on non-stat sig data with an N of 62.
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