Northwest Biotherapeutics Receives Final Approval Of PIP From MHRA

(RTTNews) - Northwest Biotherapeutics has received approval from the UK Medicines and Healthcare Products Regulatory Agency for the company's Pediatric Investigation Plan, which includes 2 clinical trials: one for newly diagnosed pediatric high grade glioma, and one for recurrent pediatric HGG. In each of the pediatric trials, 24 patients will be treated with DCVax-L on the same treatment schedule as in the phase III trial in adult glioblastoma patients.

The company submitted its proposed PIP to the MHRA in February 2022, and has been going through the regulatory review process since then. The PIP approval is a pre-requisite for application for approval of a new medicine for adult patients.

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