Replies to post #670116 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

“The approval may include a deferral allowing the pediatric clinical trials to actually be carried out after the MAA has been submitted, but the PIP approval itself must have been received before an MAA can be filed and go through compliance check.

Northwest Biotherapeutics worked with expert consultants for months to develop a PIP tailored for application of DCVax-L to pediatric cases of HGG. 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. — August 2022”

[exwannabe]

I am also curious if the assertion that the PIP trial(s) must be launched is true.

All I see in the PIP is that they were granted a deferral and that the PIP is complete summer 2028.

EDIT: Thanks flipper, missed that. So it says they do not have to be initiated prior to submission. Where does it say prior to approval?