Replies to post #777750 on NorthWest Biotherapeutics Inc (NWBO)

[Zadie420]

Finally someone telling the things as they stand. No ASM, no updates for years, no proof of anything.  We bought a product from Rosewell but with no updates in trials, we have  a great product called DCVax- D with no further updates except here or there some medical institutions ran a couple of tri with great results. Yep and we blame HFs/ shorts. 

[manibiotech]

And no plan for FDA submission that we know of 

[Investor082]

Nicely captured. You seem to be a reasonable, unbiased person who cares about his investment. Unlike minions here who enjoy averaging down year after year, coming up with excuses, and/or living in denial!

We are on track to dilute 250M to 300M shares this year. It was around 125M last year. So at this trajectory, they will likely dilute 500M shares or more next year. And that’s not even considering the money and additional dilution they will need to run an additional trial or two.

LP may need to ask for an increase of another billion shares soon given that they are already over the authorized 1.75B shares (considering options, warrants, etc.)

[10baggerz]

Agreed, and no concrete plans to restart direct trials either, just promises every year for a decade. Also no plans for Eden biosimilarity studies…

One thing that I do agree with management on (at least in concept) is the UK application first. I don’t think the FDA would have been as “approving” of ECAs or of the “artisanal” manufacturing process, so I do give management some credit especially for the SAP revisions and UK MAA application first (especially with the updated UK ECA guidelines finally coming into being)… without these 2 actions the company would be bankrupt already.

[meirluc]

Perhaps the MAA has neither been approved or rejected for 500 days and counting
because the MHRA at some point after its submission concluded that without
incorporating a full operative EDEN manufacturing capacity in the MAA, it could
not issue an approval.

This may account for the delay because it would have added much time to
validate that EDEN's products met at least the efficacy standards of the manual
vaccines.

This is my best guess and I too doubt that the delay has anything to do with
approval of cancer indications beyond nGBM and rGBM. Of course I would
be delighted if we ended up with an approval to treat additional cancers but
I believe this to be a very long shot.

[AllSheWrote]

Does anyone here understand that a rejection doesn't have to be in the form of an actual outright rejection letter that the company would have to, presumably, disclose at some point? Rejections can come in different forms. One possibility is that the application has been returned to the company with stipulations that are impossible to meet - such as, "We would be happy to approve your application but you will need to show us the patient-level data from the outside comparison groups so we can see proof of how great your vaccine is instead of just taking your word for it." A stipulation of that nature would be impossible for NWBO to resolve and would therefore constitute an effective rejection, but one that NWBO could simply sit on and feel no obligation to disclose to shareholders. That's not only possible, it's a highly likely scenario of what has actually occurred. NWBO doesn't have to do anything except keep paying themselves and if they say anything at all they can keep repeating that they "continue to be engaged with MHRA", and then they can quietly withdraw the application sometime down the road. Does no one understand this?