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Posted On: 04/05/2019 11:15:07 PM
Post# of 149994
Maybe I misunderstood some conversations earlier this week mentioning that TNBC needed combo approval and would be filed as an extension or sBLA similar to mono. I understood it as once leronlimab was approved for one treatment every other indication would be an expansion/supplemental from the original BLA filing. I didn’t look into it to see if expansion/supplemental labels were based on the drug approved or indications (HIV vs cancer). Will TNBC require a completely new BLA filing for cancer, GvHD, MS, etc. and can’t be a sBLA from combo BLA?
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