Replies to post #817293 on NorthWest Biotherapeutics Inc (NWBO)

[FeMike]

It's a valid concern.

There is simply no logical explanation for why this is taking so long, and with absolutely no updates from the company it's easy to assume something has gone wrong.

[underpar71]

Plausible. It's one of the questions I asked last week. I specifically asked, does LP consider it a material event if there was a CHM referral for denial back to the MHRA? I was not given a straight answer. "I'm not involved on the regulatory side." I was told we are not the only MAA waiting 2+ years. I was told C suites construction started, hiring ramping in UK, trying to nail down manufacturing in US. And,10K should give good updates. I took that as a positive that these things would not be happening if denial was the recommendation. Also, if you listened to LP at the ASM, she was excited, almost giddy, when talking about potential approval. So, IDK.

[NotSure2]

Or maybe it is the fault of Dstock/DanishDude/Bio/Gary etc.... that kept pushing, arguing agaisnt anyone saying the approval will take in the longer range of what is available statistically, from submission to approval, building false expectation. ("this will be approve within 2 months", repeat every 2 months).

Long range statistics fall into 790-820 days, if you add NWBO complexity/no precedent, this timeframe is more likely normal.

But yeah, valid concern, starting to worry as well.

[Goats'nCrows]

Some time ago dennisdave (I believe it was dd) said our initial submission was flawed and required re-working. I do not recall him using the adjective "seriously" but if one takes license to insert that adjective into the hypothetical, the timeline, at least in my mind, makes a little more sense.

I know LP repudiated dd's clean room argument at the ASM, but no one has ever refuted the above allegation, at least to my recollection.

Imo the "Experts Who Went on Vacation" screwing up and blowing a timeline seems more probable than the rejection as you hypothesize.

Best

[flipper44]

Let me ask you a few questions then, and please understand I hate the delay as much as anyone, with the exception of waiting caregivers or patients.

1. Do you think the MHRA would rather grant marketing approval before or after the structure of supporting law(s) guidance(s) were effectively/sufficiently in place?

2. Do you think NWBO would rather risk a reimbursement increase just because it didn’t wait until April 1 for MA grant, possibly due to some gap quirk in the MHRA system?

3. Do you think the MOID guidance is just fluff and doesn’t help certain safe platforms avoid more time consuming review?

4. Do you think the ECA draft guidance is fluff and doesn’t help address long tail biologic therapeutics, crossover and pseudoprogression conundrums?

5. Do you think a BP (or large funding entity like an HSBC) would want to see the cloud over share/security count cleared before inking some significant funding agreement.

6. Do you think a BP (or a large funding entity like an HSBC) would want to see MA prior to inking some significant funding agreement.

7. Do you think the UK’s efforts, as partly laid out recently in a post by GoodguyBill, are just window dressing, and don’t sincerely try to address age old and very new issues with drug/biologic trials and approvals?

[williamssc]

Continuing to be actively engaged and going through cycles of questions, follow-up questions, requests for clarification, requests for additional data, information. Those are the cycles that we’re going through.

"We don’t have a way to predict how much further time it’s going to take. I know that’s what we all want to know. We all want to know the crystal ball, and we do too, but we simply do not have a way to predict how much further time it’s going to take at this point".

The wording "actively engaged" and "cycles of questions" sounds very much like the application is in tact and progressing, although slowly.

[AllSheWrote]

What if the extended delay in a decision is due to a potential denial that the company is either amending or attempting to reverse?

It's utterly insane that any long, at this point in the game more than two years after the application was submitted, would feel the need to ask this question in such an apologetic hypothetical manner. I mean, it's f---ing obvious!!!!! Are you people out of your minds? The MAA submitted by NWBO is scientifically invalid. It has been explained why 10,000 times. You can't just change endpoints on a trial post-hoc. You can't just dump the trial's own randomized control group for external groups that have no patient-level data. YOU CAN'T DO IT AND MAINTAIN SCIENTIFIC INGTEGRITY!!! All of the longs have their retorts about why this is not so, but these retorts are nothing more than excuses. They are all just pissing into the wind.

Listen, you may think NWBO had perfectly good reasons for doing what they did. I do not, but that's fine if you want to believe they had good reasons for making these fundamental changes to the trial. Regardless, those reasons have nothing to do with the scientific process. Even if the reason for changing the endpoints is a good one, it nevertheless rendered the trial scientifically invalid. There may have been a good reason to shift to external groups, but it rendered the trial scientifically invalid. When the MHRA evaluates an application the most important thing they do is verify the scientific validity of the trial results. NWBO's application fails this most basic test. Why do you people think they changed the endpoints in the first place? Duh! The trial was a failure and they knew it because they had conducted an interim assessment that told them as much! Why do you think they went to the UK with their application? Do you think they just decided the UK would be a better market than the U.S.? Of course not! Are you fools? The FDA told them not to even bother submitting such a joke of an application, so they tried to do an end around with the MHRA. It did not work. Scientific organizations cannot approve scientifically invalid trial results.

On another note, all this talk from flipper44 and others about waiting for new regulations to take effect is just more excuse-making and can-kicking. These regulations have nothing to do with an already completed trial and an MAA that was submitted more than two years ago. It's nonsense. The new regulations relate to new trials, not trials completed years ago! It's in the actual language of the regulation. Just read it for yourself. This is flipper44's game. His job/role here is to perpetuate this process as long as possible and keep as many shareholders on the hook as long as he can by coming up with a new crackpot theory of hope every week. He has been doing this for years, maybe decades now. Just go back and read his posts from 2018 when he told everyone how he figured out NWBO had already submitted an application to NICE. He had all the evidence! It was an undeniable fact! Of course, it turned out to be just another one of his charades. flipper44 is playing a game at the behest of someone else, but the game will soon come to an end.

Again, it's insane that you are just now coming to the realization that NWBO's application for DCVax-L has been rejected by the MHRA. The MHRA did its job a long time ago, and NWBO has known the application is dead for a long time. Who knows what procedural steps they are taking to avoid having to inform shareholders, but I guarantee they will drag it out as long as they can. Plus, they have zero compulsion about informing shareholders of anything, regardless of whether it is material. After all, they first learned about the failure of DCVax-L in 2015 when they commissioned an interim assessment of the trial and did not disclose what they learned to shareholders. Ever since then, the whole thing has been a sham. How many bright red waving flags do you need?

[Doc logic]

DJPele,

We all understand where you are coming from and as stated earlier by another poster, no one likes seeing this much dilution BUT for a platform technology like DCVax, the dilution is still worth it because of the potential to SAFELY treat ALL solid tumors and beyond.
As I have stated unequivocally before, time is the only remaining risk because of how important and well validated the science is in the research community. Even the bears and many disgruntled longs believe that a change in leadership at this point, even though I don’t want or expect this right now, will not keep this tech from moving forward. This IS the future of cancer treatment medicine and beyond.
What you are experiencing is the price being paid for the future to be made a reality when some much opposition and slowness of government to respond to change gets in the way. In other words the current absolute value, even on the LSE at the high end price ilovetech points to, and the built in intrinsic but only yet potential value from the science are at extreme polar opposites at this point and being invested requires understanding this and being able to wait out the “great rebalancing” of value. I’ve been around the block enough times to see what’s about to happen and exwannabe and all his non invested pals plan to miss out. Those wanting a sure thing right now should join him if that’s what they want but I’m looking for something much more valuable than the here and now circumstances. Best wishes.