People with Pharma/Biotech clinical trial experience/background/knowledge regarding FDA trials:
For eIND applications (Emergency Investigational New Drug) of prospective drugs, how typical is it for the FDA to provide guidance on an open-label extension for a prospective drug's Phase 3 trial and criteria for eINDs for doctors or hospitals treating patients meeting trial criteria? For example, small biotech Cytodyn's Leronlimab (potential brand Vyrologix):
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