Post by
Kingpin68 on Nov 10, 2024 10:33pm
Breakthrough Therapy Designation criteria
From FDA site
To determine whether the improvement over available therapy is substantial is a matter of judgment and depends on both the magnitude of the treatment effect, which could include duration of the effect, and the importance of the observed clinical outcome. In general, the preliminary clinical evidence should show a clear advantage over available therapy.
A clinically significant endpoint can also refer to findings that suggest an effect on IMM or serious symptoms, including:
A significantly improved safety profile compared to available therapy (e.g., less dose-limiting toxicity for an oncology agent), with evidence of similar efficacy.
Let's go Theralase. Hope the application is already in and FDA is on it.
Will good things come to those who wait ?