Replies to post #744430 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

I recall that years ago, well before Top Line Data was published, it was discussed in this forum that NWBO was already in talks with NICE. I cannot believe that for all this time Management has been sitting on its collective backside since then having no further contact with NICE to agree a mutually acceptable price for immediate application when NWBO receives the OK from the MHRA.

I would hope that when the MHRA announces its blessing, at the same time NICE will announces that they and NorthWest Biotherapeutics have agreed a price for DCVax-L and that it has been accepted into the armamentarium of the NHS with immediate effect.

NICE first put -L on the schedule in the summer of 2016. It was later suspended because NWBO was not ready for the evidence submission which is required for the appraisal.

It went back on the schedule 2 years ago and NICE has been waiting for the evidence submission. At the ASM NWBO informed us they had not yet started on the submission by at least hiring the contractors..

NICE needs that submission to start the process.And now we know they have just started the process of working on it. And this is not a trivial document.. The document is a complex instrument that must attempt to model both the overall effect on QALYs and cost to MHRA (all cost effects, both + and -). This is not just some hand waving stuff.

After that is submitted MHRA finally can go to work on the complex analysis on their side where they will go their own numbers. And that also takes time. Then, about 6 months after NWBO submits, they will have a draft recommendation.

Any such delay post approval (if it was to actually happen), would sit squarely on the shoulders of LP as the single blocking step was clearly the evidence submission which was in her court for several years.

[learningcurve2020]

If LP actually wants any kind of share price appreciation she’ll need both. Otherwise it’ll purely be a retail one day play and then back to 30 cents. I’m 50/50 on what she prefers. This all assumes there’s even a chance the application is legit and being considered, of course. The way it’s set up now there’s just no way institutions will buy in.

[JTORENCE]

Depends who contacted who. If Nice contacted NWBO GOOD SIGN THEY ARE AT THE FOREFRONT . If NWBO contacted Nice, then given their lying history , just chalk it up to more BS from LP.IMO

[manibiotech]

Yes it was discussed
They are still in talks 
It's called being persistent and consistent 

[froggmister]

I cannot believe that for all this time Management has been sitting on its collective backside since then having no further contact with NICE

As mentioned, this has been addressed. Here's the transcript of that discussion at the ASM:

LP:

After the MAA, and the commercialization preparation, and those activities, we also need to go through the process of applying for approval for reimbursement. So in the UK, that's a process that is handled by NICE. And NICE has been absolutely wonderful to us. I cannot say enough things wonderful about NICE. They've been supportive. They've been flexible. They're standing by.

We talk to them. They reach out to us every couple of months to check on the status of things. I mean, I couldn't imagine a government agency, that's been so supportive as they've been. What we will need to do is, we'll need to engage specialized consultants to develop, what's referred to, as a health economics model. We have to make an economic model about the cost benefits of the DC vaccine treatment, and how it fits with their policies, and that sort of thing. So, that for sure will be, in our grouping of top priority activities, over the, as we look forward, over the coming 18 month period, 12 months, whatever.