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photonic5

09/11/19 8:32 PM

#243800 RE: beartrap12 #243792

Dr. Ashkan still performs DCVAX surgeries in the UK.

DI is the lightning bolt between shareholders and management on the trial results. He knows we are all chomping at the bit for results. I’m sure all of management knows. I’m sure they’ll give us information as fast as they can, but I’m sure they aren’t going to jeopardize the data review process by oversharing.

Tom Petty sang it best...The waiting is the hardest part.

flipper44

09/11/19 11:26 PM

#243813 RE: beartrap12 #243792

"pretty sure"

:-)

I've been around the block....

longfellow95

09/12/19 2:03 AM

#243821 RE: beartrap12 #243792

Thankyou, Beartrap.
It's good to have that bit of extra confirmation that DCVax-L is being used to treat a few patients in the UK.

It is the UK Specials programme that allows this to happen.
It has to be at the request of a physician directly responsible for the individual patient concerned. And to meet the special needs of that individual patient that cannot be met with a licensed product.
The supplier cannot 'solicit' orders.
The supplier is able to set a price and be reimbursed.
The manufacturer has to have a UK Specials Licence.
And our manufacturer is Advent, operating out of CCGTT (who have the appropriate licence) in London, where Mark Lowdell is the Director.

One assumes that numbers are very small. Maybe 1 or 2 a month, though that's just a guess.

Clearly, it will be UK neuro-oncologists/surgeons with an awareness of DCVax-L, who will be doing the prescribing.
And most likely Dr Ashkan does some of these. But not necessarily all of them.
Suspected or actual adverse events must be reported.

I don't think the patient has to be a UK citizen necessarily.
And the UK Special drug can be exported for use on a patient in a different EU state.

What is not entirely clear to me is who pays.
I think it is down to the patient (hence the online funding appeals), but the guidance document doesn't actually say that the NHS doesn't do the funding.

So NWBO can certainly cover all their costs in relation to supply under UK Specials, and there is nothing to preclude a profit element.

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/373505/The_supply_of_unlicensed_medicinal_products__specials_.pdf


JRIII

09/12/19 9:55 AM

#243847 RE: beartrap12 #243792

I asked him about the trial and the SAP and he said he was unable to tell me where they were in the process.



Too funny. "I'll get back to you on that as soon as I have some info." Now that, my friends, is how you tell your story! OMG, it's just beyond laughable. How much are they paying this dude?

Today another legitimate company announced a failed P3 trial, which is what you are supposed to do when you know your trial failed to meet its primary endpoint. For some reason NWBO doesn't think that standard applies to them, but they will have an opportunity to explain why they think that in the not-too-distant future. They better hope the judge buys their story.

And BTW, those who claim it's impossible to believe the treatment works while at the same time believing the trial failed are idiots. Pathetically shallow thinking and proof they have no idea what they are talking about, because that's exactly the situation here. If you don't understand how that could be, then perhaps you are following the wrong company.