Replies to post #721952 on NorthWest Biotherapeutics Inc (NWBO)

[Investor082]

Equally, if not more important, is why didn’t they submit reimbursement evidence 6-9 months ago in parallel with MAA submission when UK has been their immediate focus and their survival depends on it.

Although, FDA is 10x the market size of UK, it’s clear that they don’t plan on applying in the US anytime soon because they are worried FDA will not approve based on phase 3 data alone. Otherwise they would have picked US over UK from the beginning. And why wouldn’t you when the TAM is 10 times?

[flipper44]

Have you thought of this scenario? Just a what if.

What if DCVax-l is approved by MHRA, and thus commercial Eden could quickly get approved alongside commercial (already approved) artisan.

Meanwhile, the combo trial released, and due to the lack of other therapies for rGBM in U.S., we apply for rGBM phase I combo therapy approval in U.S. based on combo trial clinical responses (tumor shrinkage) and backed by 15 year old monotherapy rGBM trial showing safety/survival advantage.

Demand skyrockets, but luckily, as everyone starts storing their tumors, EDEN is approved for manufacturing in UK and through reciprocal
Recognition in US, then, US approves combo for rGBM and massive demand.

People don’t realize Dr. Pazdur’s strong belief in getting convincing early trial result therapy to
Patients in an orphan disease (rGBM) on a commercially accelerated basis. Even with phase I data — if highly persuasive.

The real difficulty in such a hypothetical is timing supply with demand. Create demand too early, and you don’t have supply. Hence the delay in moving forward in US until ducks are lined up.

(Anyway, beyond that, UK then approves combo through international recognition (drug prices are set), trials in other indications at warp speed, etc.)

This was just a hypothetical to present one possible answer to your question.