Replies to post #689027 on NorthWest Biotherapeutics Inc (NWBO)

[Smitty5150]

I think you need to brush up on your DD. NW only needs to PIP plan approved, not active ongoing or completed trials for submission and possible approval of DCVax in adults. Once again, you are just showing all the users here just how ignorant you are. Nothing you say should be taken seriously, not even a little.

But I am here to help you. Here is a little info to help you brush up on your MHRA approval skills.

https://www.labiotech.eu/trends-news/northwest-biotherapeutics-cancer-pip-approval/

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 consultants 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 approval was given on August 17.

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.