Northwest Biotherapeutics Announces -
Approval of Pediatric Investigation Plan (PIP) by MHRA
#DCVaxL $NWBO newsfilter.io/a/8ae27d3f0428…
Approval of Pediatric Investigation Plan (PIP) by MHRA
#DCVaxL $NWBO newsfilter.io/a/8ae27d3f0428…
“The development, regulatory review and regulatory approval of a PIP is a pre-requisite for application for approval of a new medicine for adult patients, such as DCVax®-L.”
“The Company submitted its proposed PIP to the MHRA in February 2022, and has been going through the regulatory review process since then. On August 17, the Company received final approval of the PIP from the MHRA.”
“The Company's approved PIP includes a deferral under which the pediatric trials are anticipated to be undertaken after an MAA application has been submitted.”
Significantly:
“The primary endpoint for each of the 2 pediatric trials will be overall survival, determined by comparing the survival of DCVax-L treated patients to matched contemporaneous external controls.”
“The primary endpoint for each of the 2 pediatric trials will be overall survival, determined by comparing the survival of DCVax-L treated patients to matched contemporaneous external controls.”
“The external controls will be identified using the same methodology as was used to pre-specify the external controls in the Statistical Analysis Plan for the Company's Phase III trial in adult patients.”
Looks to me like short speculation and narratives regarding the just finished Phase 3 trial are looking very weak! $NWBO #DCVaxL
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