Moderna Inc (MRNA): A breakthrough therapy designation is fo...

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Re: None

Monday, 01/30/2023 9:24:45 AM

Monday, January 30, 2023 9:24:45 AM

A breakthrough therapy designation is for a drug that treats a serious or life-threatening condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies.

https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy

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