"It’s already been discussed that a phase 3 woul
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Posted On: 08/19/2020 11:53:33 AM
"It’s already been discussed that a phase 3 wouldn’t make sense because we’d just make our end point NEWS and we’d get an even lower p-value."
Careful... Under normal circumstances, that certainly won't be the logic of regulators, who regularly see Phase 2 studies with great results and p-values fail miserably in larger Phase 3 studies... Otherwise, any drug for any devastating disease would be approved after a Phase 2 study, which clearly isn't the case... Just take Alzheimer's: so many drugs with good Phase 2 results over the years that all have failed in Phase 3 so far... The reasoning: Phase 2 results great -> Phase 3 results even greater, is inaccurate...
(I'm not saying EUA won't happen, since there is a pandemic with high unmet medical need, but impossible to say what FDA really thinks about our study, especially if they proceed according to textbook; a Phase 3 study is definitely a 50% possibility)...
Careful... Under normal circumstances, that certainly won't be the logic of regulators, who regularly see Phase 2 studies with great results and p-values fail miserably in larger Phase 3 studies... Otherwise, any drug for any devastating disease would be approved after a Phase 2 study, which clearly isn't the case... Just take Alzheimer's: so many drugs with good Phase 2 results over the years that all have failed in Phase 3 so far... The reasoning: Phase 2 results great -> Phase 3 results even greater, is inaccurate...
(I'm not saying EUA won't happen, since there is a pandemic with high unmet medical need, but impossible to say what FDA really thinks about our study, especially if they proceed according to textbook; a Phase 3 study is definitely a 50% possibility)...
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