Replies to post #796332 on NorthWest Biotherapeutics Inc (NWBO)

[DocLee]

I would suggest that the MHRA are not living in a blinkered world. The MHRA, like us, can see from small studies (rather than full blinded controlled trials) that real world data shows that survival and probable cure rates (up to median survival rates of over 50%) are increased considerably with the addition of poly-ICLC and pembrolizumab either singly or in combination. It is apparent to them and NICE (the latter deciding whether the cost to the NHS is justified by the results of the treatment) that it is now not a life extension of a few months but for many years or even cure for many.

MHRA will (in my opinion) give DCVax-L it's licence and NICE will agree terms with NWBio which will likely be cheaper than the current SOC that Big Pharma charge. The cost will, I suspect, be tempered in the light of the current furore between pharmaceutical companies and the UK government in which the former claim that terms of remuneration demanded by the latter are making operating in the UK unprofitable. As a result, some pharmaceutical companies have begun to transfer operations (research and production) from the UK to other jurisdictions in which their products can be charged at higher rates. I suspect that this will help NWBio in its discussions with NICE.

[exwannabe]

Maybe the MHRA are having a hard time justifying paying big bucks for a GBM vaccine that gives 2.8 months longer median survival for newly diagnosed patients and 5.8 months for recurrent patients.
Okay, the 13% of long tail patients are fantastic, but is it enough to sway MHRA?

The British economy is in a bad place right now, they are talking about tax hikes to fill the big holes they got.

Gus, the MHRA does not evaluate the cost effectiveness of the drug. It is a separate review by NICE that does that,

The NICE process has not yet started as they are waitng for NWBO to submit to them. The NICE evidence submission is complex and very different from the MAA. The guts consist of an economic model that evaluates the cost to NHS vs the QALY Quality Adjusted Life Years gained). This take a lot into consideration, as I said, very complex.

But the MHRA action is 100% independent of the NICE decision.

[AllSheWrote]

Maybe the MHRA are having a hard time justifying paying big bucks

Or maybe not, since cost is not a consideration for MHRA.