NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

With the market not expecting any news from the MHRA prior to June, just gonna be a rough wait.

When the 10K came out I was very upset about one particular part in the 10K which indicated a huge delay in the MHRA and that is not the text about the cancelled ASCO event. I have to revisit this part from the last 10K:

Intensive activities continued throughout 2024, including in Q4, in multiple areas including the following: ? completion, in collaboration with leading clinicians, of the trial design and protocol for the pediatric brain cancer trials to fulfill the legal requirement for pediatric applications in connection with the MAA for the adult applications;

and

Pediatric Brain Cancer Trial. The Company worked throughout the year to obtain engagement of pediatric neurosurgeons and neuro-oncologists for the pediatric trial that is legally required in connection with the MAA application for adult patients. The clinicians requested substantial changes in the trial design and plans that had been approved by MHRA. After a long process, a new trial design was agreed by the clinicians. The Company plans to obtain MHRA approval of the new design and move forward with the trial in due course.

Then MHRA regulation:

The latest MHRA decision <PIP> must be included for validation of the regulatory application.

https://www.gov.uk/guidance/procedures-for-uk-paediatric-investigation-plan-pips
Does that mean that the present approved PIP design suffices?
IF we hear nothing this month then Im starting to fear the MHRA has decided to pause the decision until the new PIP trial design has been decided.
In any case Im not entirely sure if waiting for a new PIP decision in this specific case is standard MHRA procedure or not. I sure as hell hope not.