Need an EAP granted for stone growth.
Need the old data to support the single arm, need the old data excluded to validate the current profile. Not ideal but the FDA have been holding our hand crossing, not the committee.
Approved with a post-marketing observational study like Tecartus. (IMO)
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- Ann: Update on Scheduled FDA Advisory Committee Meeting
Ann: Update on Scheduled FDA Advisory Committee Meeting, page-66
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