(Total Views: 609)
Posted On: 09/18/2025 3:05:55 AM
Post# of 157138
Quote:
Is it necessary for LL to demonstrate efficacy toward a particular cancer in order for compassionate use to be granted?
No, however the FDA will assess whether the potential benefit outweighs any risks for both compassionate use and EIND applications. The FDA already knows the very good safety profile of leronlimab so that should never be a problem.
Quote:
Can compassionate use be granted for a cancer not previously treated through prior passionate use or any of the formal studies?
Yes
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