FDA intends to review and act on 90% of standard NDA and BLA submissions within 10 months of the filing date.
immutep and the FDA have agreed on a Phase 2/3 trial design that would prove pivotal for a Biologics License Application for efti
Immutep is adding a 90 mg dosage cohort thanks to its favourable safety profile
Sounds promising for mine
Ann: Update on MBC trial design following successful FDA meeting, page-19
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