Replies to post #522002 on NorthWest Biotherapeutics Inc (NWBO)

[CrashOverride]

How many regulators do you speak with on a regular basis?

MHRA endorsed the trial design by applying the same endpoints and external controls onto the upcoming pediatric study that will be conducted after DCVax obtains UK approval for adults. That's 250,000,000 - 500,000,000 in revenue from UK. We should see several billion annually once Sawston are able to meet European demand.

[biosectinvestor]

Virtually nothing you said there is factual or where vaguely factual, a correct summary of the reality in total.

I said Novocure is cash rich, though there was an autocorrect. I did not say NWBO is cash rich.

The trial was a well run trial pursuant to the required standards of the time, which have since been relaxed in a number of ways and it is unlikely that the FDA would require anyone to fit this kind of trial into the same requirements that were set at the time. The trial was still well run, despite that issue. There are ethical and participation issues when you have a placebo. Crossover was the only fix. PFS was a way to get results early and well established, but no one knew about the science here yet. This is why the FDA has reformed over recent years as more cell and living therapies have been introduced, a lot has been learned about the dynamism of such treatments and that unexpected new aspects of human reactions and disease pathology are learned.

They dealt with the issue and applied for approval according to the current regulations and guidance, pursuant to each country's rules. Nothing about violating rules was in their SEC disclosures. There was no indication they did a post hoc data dredge anywhere but your imagination and in fact the facts are well established and quite clear on this issue in regards to both filings, press releases and the transcript of the annual meeting well previous to data lock. The need to pile on the false info is quite strong with some, but it's just not the reality and not consistent with the facts.

No, the investor community is dealing with rising interest rates and other issues and the stock has remained relatively flat YTD. It is not uncommon for these tiny cellular therapy companies to remain modestly valued even with outstanding results fully announced, up to and through approval. The trial was run by top researchers at top research institutions on multiple continents. These researchers are extremely highly regarded by the NIH and I guarantee the MHRA and FDA. And they are better known to be experts than any anonymous posters on bulletin boards, no matter how much expertise they claim to have, including me.

That's just a reality. Validation bring valuation. Wall Street has seen other companies with great results that could not manufacture their product, and other issues so until it's all resolved, the price can often remain moderate. Nonetheless, the return for the 5 year period that I have been in is much better than many other places where I could have put my money.