Replies to post #734898 on NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

I agree, it won't happen on just the UK alone, but I believe that once we have approval of the EDEN, approvals by other regulators won't take that long.

We all know the benefits of combining with Poly-ICLC and other therapeutics, we don't need approvals in other trials for that to happen off label for most patients. I once said it would be medical malpractice if it didn't happen.

I believe that much the same applies to its use in other cancers. Trials proving it's benefits in other cancers will take several years for label approval, but again that doesn't mean it can't be used off label.

I don't know if the full records for compassionate use in the UK will ever be released, but I believe sufficient anecdotal evidence is know about patients with other cancers that it will be used once there is adequate supply, meaning the EDEN units are being mass produced to meet demands.

I can't say what trials will be run, or when they'll be run, but word will get out if benefits are being seen in cancers like pancreatic, lung, breast, etc. and that, along with existing anecdotal evidence will be all that's needed to force insurance to pay for the vaccine well before actual approval is achieved.

If I'm right about this, in three to five years from now DCVax-L will be one of the biggest earning products on the market.

Gary

[ATLnsider]

I disagree Hopeforthefuture3, it will not require another DCVax-L trial to get approval for nGBM and rGBM in the EU, Canada and the US.

To use your number of $200,000 per patient, and the following number of annual patients, just for

nGBM, in each country: UK (3,000), EU (13,000), US (13,000), Canada (1,500) = Total of 30,500 nGBM patients per year = $200,000 X 30,500 = $6,100,000,000 ($6.1 billion per year)

That is $6.1 billion in potential annual revenue, just for nGBM approval in the UK, EU, Canada and the US.

If you add another 50% for rGBM ($3.05 billion), the potential annual revenue for nGBM + rGBM, just in the UK, EU, Canada and the US, the total potential annual revenue for Glioblastoma alone is $9,105,000,000 ($9.1 billion).

If you add approval in the rest of the world (ROW), the potential annual global revenue would double to $18.2 billion, just for nGBM and rGBM.

This is solely based on the completed, peer-reviewed and published DCVax-L Phase III trial, with no new or additional trial required.

[dstock07734]

Take some time to get a billion? Can you be more specific?
I have to skip the elementary level of calculation about the revenue.

Do you think those BPs facing patent cliff will have the patience to wait for some time?

See this collaboration trial between Merck and Daiichi Sankyo about the combination of keytruda with CSF1R inhibitor which was terminated early for insufficient evidence of clinical efficacy. Can you imagine what could happen if this two is combined with DCVax-L? Sort out how many types of cancers have immunosuppression dominated by tumor-associated macrophages first and then redo your calculation.

A Combination Clinical Study of PLX3397 and Pembrolizumab To Treat Advanced Melanoma and Other Solid Tumors
https://clinicaltrials.gov/study/NCT02452424