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Posted On: 03/20/2020 1:48:28 AM
Post# of 153773
“If another phase 3 trial was required then it would be its own approval not a label extension.”
So your under the assumption that CYDY will wait for combo to be approved and then file a label expansion for mono therapy using the data from the most recent mono pivotal trial?
Honestly, I like that idea much better than another 48 week mono trial. What I’m not sure of is if CYDY and the FDA are in the same boat. NP said in Dec or Jan that the new mono therapy trial was on hold as the main effort was the combo BLA and cancer, but I never interpreted as what you’re saying here.
I think this would be a good question for someone to ask NP during the next CC or webcast he does. Or maybe someone who emails him regularly can ask him.
So your under the assumption that CYDY will wait for combo to be approved and then file a label expansion for mono therapy using the data from the most recent mono pivotal trial?
Honestly, I like that idea much better than another 48 week mono trial. What I’m not sure of is if CYDY and the FDA are in the same boat. NP said in Dec or Jan that the new mono therapy trial was on hold as the main effort was the combo BLA and cancer, but I never interpreted as what you’re saying here.
I think this would be a good question for someone to ask NP during the next CC or webcast he does. Or maybe someone who emails him regularly can ask him.
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