Replies to post #452413 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

I agree but I do believe they decided to disclose TLD with MHRA approval.

And if the MHRA is so close, why has their oncology committee (OHEAG) not even discussed it as of 1/20/22? That would happen well prior to approval.

More significantly, there is no reason they cannot get a paper published if they want to. Regardless of what the results are, it is still a P3 with a novel agent in a serious indication.

The only explanation of a journal not being willing to publish would be the paper is not providing what a paper wants. And if they cannot do so for a paper, they are going to have serious issues with RAs who want substantially more information.

[Maverick0408]

And MHRA approval is not coming this year, unfortunately! I know all the loyal supporters are going to say that’s BS and how do I know. But the fact remains any well run company will let shareholders know that their (UK) BLA application was accepted. This is a significant event. And there is no such PR yet, so it’s safe to assume it’s pending. And by the way, these same folks (loyal management supporters) were like you don’t submit BLA before TLD when questioned on why they have made limited (parallel) progress on RA in the last year or so. They can’t have both ways! ;)

For me personally, if they don’t update the clinical trials website in a few weeks after the final FDA guideline document comes out (which I anticipate before end of April) then I have serious concerns about their FDA pathway and chances of success there. So I think the next 2 months will provide a great deal of clarity!

Having said that, I do believe they are likely to get UK and EU approvals, but unfortunately they are not coming this year. Waiting game will continue!