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Tuesday, June 20, 2023 11:17:14 AM
During 2023, the Company anticipates that additional key areas of focus will include:
commencing the pediatric clinical program required under the PIP
https://nwbio.com/northwest-biotherapeutics-announces-positive-votes-at-annual-meeting-reviews-2022-progress-and-looks-forward-to-strong-2023/
The PIP can start before MHRA approval of DCVax:
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.
https://nwbio.com/northwest-biotherapeutics-announces-approval-of-pediatric-investigation-plan-pip-by-mhra-pip-approval-is-a-pre-requisite-for-application-for-approval-of-a-new-medicine-for-adult-patients/
So as we can see management expect to have the MAA submitted this year with the PIP clinical trial underway. There's plenty of time left for these events as well as MHRA approval of DCVax for nGBM and rGBM indications. MHRA would not allow the PIP trial to run on children at MAA submission if they thought DCVax wouldn't be approved. Drug regulators do not arbitrarily experiment on children!
Do your own research. I am not providing legal or investment advice. This is an anonymous forum for entertainment purposes only. Don't trust anything you read.
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