NorthWest Biotherapeutics Inc (NWBO): "The final regulatory approval of the PI...

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NorthWest Biotherapeutics Inc (NWBO)

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Tuesday, 08/23/2022 9:34:15 PM

Tuesday, August 23, 2022 9:34:15 PM

"The final regulatory approval of the PIP must be obtained before a sponsor may submit a Marketing Authorization Application (MAA) for approval to commercialize the new medicine for adult patients."

"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."

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Can we receive MAA approval before regulatory approval of the PIP? Or can we only submit a MAA?

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