Replies to post #790049 on NorthWest Biotherapeutics Inc (NWBO)

[cptbac]

Thanks DD. I forget if you or someone else said a while back could be as late as January/ February before complete. Is that correct? Thanks

[10baggerz]

100% AGREE and I don't know why everyone (bulls and bears) is so dismissive of this theory. 
It's literally the only theory that explains everything from the seemingly unexplainable never-ending MHRA "rapid review", to the fact that the MHRA keeps saying there is no backlog, to the fact that if there were major issues or unobtainable RFI's with the MAA, it would already have been rejected, to the fact that we are pretty much beyond the point where the delay can be explained by RFI's, and most importantly it matches what NWBO literally TOLD US in their latest 10Q:
"Comments on Potential New MHRA Policies. In the UK, the MHRA issued a draft guidelines of IMPORTANT potential NEW POLICIES under which clinical trials WOULD be allowed to use external controls instead of within-study placebo arms, especially for severe or rare diseases, and the MHRA called for public comments during the second quarter. The Company worked together with physician collaborators, patient groups, statisticians, academics and political representatives to help mobilize public comments.”

It also fits together nicely to the announcement of the Advent purchase  NOW, the purchase timeline, and the associated PR which basically states that DCVAX will be approved. 
Also it matches up with NWBO scheduling conferences (placeholders) for LP in the coming months.
Also it's congruent with previous NWBO milestones taking forever but never overdilevering.
Also, this explanation is soo much more likely than AI bulls pie in the sky secret manufacturing approval, tumor agnostic approval, or project ORBIS.
Also, this explanation is soo much more likely than paid FUDSTER's doom and goood theories of MHRA stealth rejections via "MAA purgatory" or needing to complete pediatric trials, or by requiring unobtainable patient level ECA data.

[martyDg]

What are you going to do if this drags on another six months—or even a year? Just sit there, watch, and wait without pushing management for a real update? I can understand 150–500 days of silence—that’s still within reason. But 645 days? That’s 4.3 times the normal timeframe, and it’s clear something is wrong—or, if not, there are major issues at play. Management now has an obligation to provide an update and stop hiding behind the excuse that “the only update” will come with a decision.
It was acceptable for them to stay quiet during the first 150–300 days while applying for rapid 150-day approval, but that’s long past. They are well beyond any reasonable timeframe. Whether the delay is due to new guidelines or waiting for 10-year overall survival data, 645 days of silence is unacceptable. They need to stop keeping us in the dark.

[Investor082]

But you were also confident about approval in March-April timeframe and this was not even in play then.

You can link to this guideline and framework as much as you want but the more likely explanation is that the data is messy. You can also glean this from MHRA’s response to one of the posters recently that the finalization of this guideline is not important for approval as long as the efficacy and safety profile of the therapy is compelling. So again the likely explanation is that MHRA have asked some difficult questions that NWBO is unable to address at this time. Given the political pressure as well as support from UK’s KOLs, MHRA may have likely provided some extension and have’t rejected the application outright.

NWBO will likely drag this out until they have approval on authorized share count increase. At that point, they might tell MHRA that they are unable to furnish what they asked for or just provide inadequate response and that’s when MHRA is likely to reject. In the meantime, minions will hype new trials to deflect and minimize the blow from UK rejection.