Replies to post #774058 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

the reason why these idiots COULD NOT submit in the US is that the FDA does NOT offer guidelines for an ECA RWD (especially without IPD) based BLA.

See the FDA guidance on RWE/RWD

[FeMike]

Why is that so difficult to understand for you?

When did I refute this?

I'm not sure what the reasoning or explanation has to do with the point I made. It all lends credence to Linda's complete and utter incompetence, and my claim that NWBO has no intentions of submitting a BLA for DCVax-L.

[manibiotech]

So you are implying then that they have been misleading everyone when they said RA's almost 3 years ago, and will be working with consultants for FDA (or other RA's , can't exactly remember the wording used) .?

[kabunushi]

Dc-Vax-l if approved, is potentially a big threat to Novocure's considerable revenues for their Optune TTF helmet treatment for GBM. In 2024 NVCR reported $400M revenue in the US, $120M in Germany and France. Their revenue in the UK isn't broken out - AFAIK it's minimal. Optune is VERY expensive - think $10k or more per month. In the US and EU, a few docs are making significant $ advising NVCR and maybe a bunch more are, in one form or another, making $ monthly directly or indirectly from prescribing the device. I'm pretty sure that NWBO's plan to get DcVax-l approved in the UK, then to have it move into the position of SOC for GBM in the UK, and only then to go for approval in the US has always been driven by consideration of FDA politics. The dcVax study is far from perfect and there is room for anybody who is asked, to recommend shooting it down, without needing to worry much about any complaint of bias. This is basic RA political background that, imo, one ought to understand well before calling LP stupid.

The only doc I know from the Optune study is Stupp, who is a heavy hitter, and I'm sure, influential with the FDA. But all of the journal articles I've read that attack the dcVax study were written by docs who prescribe Optune. I have no idea whether they get paid per device/month of their patients who use Optune, but in any case, they are conflicted and from what I've seen, most didn't disclose anything about the conflict.

I'm not saying the whole thing stinks of Novocure-related $ influence. I'm only suggesting that people consider the politics of RA approval when considering why NW applied to the MHRA and hasn't yet applied to the FDA. Possible similar considerations WRT to the EU? I have no idea about that. It does seem clear that with Dr Askan as a very influential doc at the national level and a very strong supporter of DcVax, there are clear reasons why NW went to the MHRA. If they are waiting to get established as SOC for GBM in the UK before applying in the UK and EU, it's a damn shame for us as investors that it's taken so damn long.