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Re: catdaddy post# 445637

Thursday, 01/04/2024 12:14:16 AM

Thursday, January 04, 2024 12:14:16 AM

Post# of 464813
So, You're saying there's a chance?

Interesting article. 2-73 tics a lot of the boxes in the list of those that were approved.


Of the identified 210 NDA approvals in the observed time period, Johnston and colleagues observed 21 (10.0%) that included null findings for ≥1 primary efficacy end point; each of the 21 drugs were approved for unique clinical indications. More than half (n = 11 [52.4%]) were first-in-class approvals; 10 (47.6%) previously received an Orphan Drug Designation; 13 (61.9%) received an expedited review pathway from the FDA. Only 3 (14.3%) required an advisory committee meeting prior to FDA approval.


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