Replies to post #776120 on NorthWest Biotherapeutics Inc (NWBO)

[learningcurve2020]

You should ask IR to confirm this. Seems simple enough. Please post the response.

>>Any variation to a MAA would be a material event and require disclosure as it is way outside the norm.

[seekinganswers]

Not necessarily a material event that needs to be disclosed.

A variation in the context of the MHRA (Medicines and Healthcare products Regulatory Agency) typically refers to changes in a marketing authorisation that can affect a product's quality, safety, or efficacy. Such variations are considered significant events that require proper documentation and approval, but whether they are classified as "material" can depend on the specific context and implications of the change.

https://www.gov.uk/guidance/medicines-apply-for-a-variation-to-your-marketing-authorisation

NWBO appears to be working through it..

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.