It is also false to claim that breakthrough therap
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Posted On: 04/25/2019 9:44:22 AM
It is also false to claim that breakthrough therapy designation has any relevance to whether a clinical trial was successful or not.
What is important is whether a drug has great clinical trial results or not, not whether some bureaucrat may or may not have made a ruling on BTD.
This is a completely false narrative. If BTD were so important, would this mean that any drug in a clinical trial that did not get BTD should be abandoned? Of course not. That would mean that the FDA was making a judgment on the efficacy of a drug before a phase 3 clinical trial, which is absurd.
Let's also remember that there have been drugs that got BTD and failed in their Phase 3 clinical trials. This is NOT an FDA opinion on the efficacy of the drug, and to say otherwise is a lie.
What is important is whether a drug has great clinical trial results or not, not whether some bureaucrat may or may not have made a ruling on BTD.
This is a completely false narrative. If BTD were so important, would this mean that any drug in a clinical trial that did not get BTD should be abandoned? Of course not. That would mean that the FDA was making a judgment on the efficacy of a drug before a phase 3 clinical trial, which is absurd.
Let's also remember that there have been drugs that got BTD and failed in their Phase 3 clinical trials. This is NOT an FDA opinion on the efficacy of the drug, and to say otherwise is a lie.
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