NorthWest Biotherapeutics Inc (NWBO)

[maverick_1]

Longfellow95 re:Perhaps they're not going to bother with the FDA...

So, Europe, UK, Canada, and Japan.

Longfellow95:

You are my designated MAVEN.

1) Does NWBO submit SAP to MHRA and NICE for UK or given the below does NICE have a leg up??

In UK 5 years ago:https://nwbio.com/first-uk-promising-innovative-medicine-designation-awarded/

AND this:

Recently, Davis et al. [2] reported that the majority of oncology drugs approved by the EMA between 2009 and 2013 were “…without evidence of benefit on survival or quality of life” [2]. The authors reported that, at the time of EMA assessment, significant prolongation of survival was reported for 24 out of 68 indications (35%) and there was an improvement in quality of life for seven out of 68 indications (10%). The clinical benefit of the new drugs remained uncertain for 33 out of 68 indications (49%) after a median follow-up of 5.4 years post-marketing authorisation [2].

In England, the National Institute for Health and Care Excellence (NICE) has a mandate to appraise drugs approved by the EMA in a timely fashion with a view to making recommendations regarding their routine use in the National Health Service (NHS) [3]. This mandate makes it necessary for NICE appraisals to be undertaken using the data available at the time of, or near the point of, regulatory approval. The level of evidence that informs the EMA’s conclusion of a positive benefit/risk balance therefore plays a large part in determining the level of uncertainty present in each NICE appraisal

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6028888/

A long time ago, I believe we exchanged posts and left it that the BIG FEE ($NWBO constrained... Not now?)would need to be accompanied with it's next submission at NICE.

Have you seen NICE approvals BEFORE MHRA?

How does Japan enter the picture?
IF ALL 4 RA's: FDA, EMA, MHRA/NICE, Canada approve SAP does Japan go along WITHOUT Japan trials?

Sorry to put you on the spot Longfellow.

DIFFERENT STROKES FOR DIFFERENT FOLKS