NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

NotSure2, the document that I referenced was a brief summary, and not from a regulatory agency. To answer your question: yes, that sentence, “The UK paediatric investigation plan (PIP) compliance check (CC) should be performed 60 days before the submission.” should be understood to mean at least 60 days before submission. The EMA provides a Q & A document about the Pediatric Investigation Plan which clarifies the question:

Questions and answers on the procedure of PIP compliance verification at EMA, and on paediatric rewards

8. How early before submission of the Regulatory Application can a compliance check be requested?

The Paediatric Regulation does not establish a timeframe for the compliance check prior to submission of the Regulatory Application.
To prevent delays at the time of validation of a Regulatory Application, applicants are encouraged to request compliance check by the PDCO at least 2 months prior to the planned submission of a Regulatory Application, in keeping with the submission timelines indicated on the Paediatric investigation plans: Templates, forms and submission dates page.

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-procedure-paediatric-investigation-plan-compliance-verification-european-medicines_en.pdf

I think that all of us, who are actually invested here, hope that Northwest Bio would get the marketing application(s) submitted already, and will receive a rapid review and approval. My experience investing in Northwest Bio has taught me that timelines suggested by longs are usually too short, and timelines suggested by bears are often too long, and Northwest Bio tends to land somewhere in the middle.