• Small biotech US company developing a dendritic cell vaccine for the treatment of the Orphan indication glioblastoma in EU
  • Timeline: long-term (8 years)
  • Support in

-Preparation and conduct of the Scientific Advices (SA)

-Medical and technical Writing

-Clinical trial Phase III

-Adaptive pathway

-Early access medicines scheme (UK)

-Hospital exemption (DE)

-Pediatric Investigational Plan (PIP)

-Pharmacovigilance: DSUR and PSUR

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