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Galzus, I respect you—that’s the only reason I haven’t muted you. Honestly, there’s nothing left to prove here. Let’s wrap this up, it’s getting unproductive. Maybe take a break and come back after your next article 🙏🙏🙏
Galzus, if you want to maintain any respect here, limit your posts.
At this point, your motives are clear, and frankly, most of us aren't interested.🙏🙏🙏
TVOP, based on your last message, you mentioned that if approval doesn’t happen by May 6th, 2025, the application would be in unprecedented territory. Are you still standing by that timeline, or has anything recent changed your view?
The third quote is from a post on 2/4/25. The timeframe mentioned in it refers to something I mentioned in another post on the same day, in which I gave a specific date (5/6/25) after which our application would officially be in unprecedented territory. I stand by that date as a point at which I personally would begin to feel worried about how long it was taking (even though, since that time, mRESVIA received approval with an even longer timeline).
Their most recent 10-K shows $1.4M listed under "Research and Other" revenue. Any idea what that might actually be?
first quarter revenue post UK approval
Can you let them know to go ahead and start buying now?
Mike, I remember that you—or maybe Branster or someone else from the board—reached out to DI to verify the rumor about whether the MHRA application was backlogged or delayed. I’m not certain who exactly followed up, but did DI ever respond or confirm anything? I know Lykiri received a direct response, but hearing it from DI as well would definitely boost our confidence—just to be doubly sure.
The good news is that by plenty of case law, RA actions that are not final are not something that require disclosure. So they can punt the ball another half year r so until forced to withdraw the application or get publicly rejected.
He appears to have been consistently active on iHub since the last price spike. It seems likely that this is part of his job—to monitor the board and quickly publish articles targeting NWBO whenever positive news surfaces. Based on that, I’d say option B is the more likely scenario.😃
From ChatGPT
The application for the Vimkunya chikungunya vaccine was submitted to the UK Medicines and Healthcare products Regulatory Agency (MHRA) in February 2025. This submission was made under the international recognition procedure, based on the positive opinion adopted by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in January 2025. The vaccine was approved by the MHRA on May 1, 2025, for the prevention of disease caused by the chikungunya virus in individuals aged 12 years and older .
Mani, I agree with Lykiri’s perspective on this. If things are moving in the right direction, Northwest is likely using this time to focus on essential administrative steps. Given that they operate with a lean team, receiving approval around the time of ASCO could easily cause delays. According to their recent 10-K, they intend to act quickly on MHRA-related matters and already have partners lined up — they're simply waiting on approval. That positions them to move swiftly on the business front without needing to divert limited resources to ASCO. Besides, if approval does come through, the entire biotech community will be aware, whether or not they’re at ASCO. In my view, skipping ASCO at this point isn’t a concern, especially with the time pressures they’re facing.
Showing your true colors again!
Doc, I have great respect for you, but I’m with Attila on this one. The lack of clear updates from the company has been really concerning, which is why we’re all analyzing every bit of news that comes out of the MHRA. It would mean a lot if the company addressed the rumors directly and clarified something like: 'We are still under MHRA review and have not received any indication of a hold, rejection, or approval at this time. We ask for your continued patience as we work through this long and complex process — we believe a decision is approaching.' A message like that would do a lot to rebuild confidence during such a critical phase.
No, I think he's suggesting that if we make enough noise about this issue, the company might respond with a message like that.
No need to get frustrated — take a moment to read others comments carefully, and let’s respond respectfully. we/I'm not here to argue on anything, just to share perspectives.
Who said it didn’t drop to 27¢? What I said was that some encouraging news at this point could give the stock a push — especially with the volume we’ve seen over the past ten days — and help keep it above the 30¢ range until we hear from the MHRA.
IMO, some encouraging news from the company could definitely help keep the stock price around the 30¢ range.
We’ve pretty much gotten used to the dilution over the past couple of years. At this point, I just hope for a bit of news to reassure us — something to show that we’re still on the right track during this long period of silence.
Man, they’re dragging it down hard!
Q: DCVax was already in the DrugBank system since April 2023, but now, two years later, I noticed a recent timestamp showing the entry was updated. Could this update have any significance? Does it indicate or confirm anything? 😃
ChatGPT: If DCVax-L was originally added to DrugBank in April 2023, and you're now seeing a recent timestamp indicating an update, that can carry some significance, though it doesn't confirm anything specific like approval. Here's why:
Possible Significance of the Update:
1. New Information Became Available:
DrugBank updates entries when there's something new — clinical trial results, regulatory changes (e.g., application status), new mechanisms, formulations, or even manufacturer details. So, an update might reflect recent progress or data made public by the company or regulators.
2.Increased Scientific or Clinical Relevance:
Updates can signal that the drug is becoming more relevant — either due to heightened interest, increased citations in literature, or nearing approval. DrugBank’s team curates based on what’s noteworthy in biomedical circles.
3. Data Validation or Correction:
Sometimes, updates are just minor — fixing formatting, correcting references, or aligning with new naming conventions. That wouldn’t imply anything major, but the timing can still raise curiosity.
4. Timing Raises Eyebrows:
If the update comes just as investors are anticipating regulatory news (like MHRA approval), it could suggest that DrugBank's team was prompted by something new — such as internal signals or third-party publications.
Does it confirm anything?
Not directly. DrugBank is not a regulatory body, so an update there doesn't confirm approval or inside knowledge. But it might suggest that DCVax-L is gaining scientific traction or nearing a meaningful milestone.
thanks! Yeah, I didn’t notice it at first in all the excitement. When I initially asked ChatGPT, it said DCVax wasn’t in the DrugBank system. Still, this feels like a positive sign. They could’ve updated it around this time last year, but why now? Maybe they were recently informed of something.
Wow! So DrugBank has added DCVax-L to their database for the first time — that’s great to see!
Q: Will there be any significance if the DrugBank adds any new drug to their system?
ChatGPT: Yes, there can be significance when DrugBank adds a new drug to their system. It often means that the drug has reached a stage of scientific or regulatory relevance — such as entering clinical trials, gaining approval, or having enough publicly available data to warrant inclusion. It can also signal growing recognition or validation within the biomedical community.
Great, Thank You!
Galzus, like someone here already pointed out — why did you suddenly appear with your article right when the stock started spiking? And why have you been spending so much time on iHub since then? Most of us have been here for a long time, riding out all the ups and downs. Honestly, we’re not debating whether this stock is a good or bad investment anymore — at this point, all we care about is the approval.
Since you're hanging out here like one of us now, mind giving us a little heads-up before you start cranking out your next round of articles — you know, once approval hits?🙂
DD, here’s what I got from ChatGPT when I asked about a DrugBank update on DCVax.
As of April 2025, there are no recent updates from DrugBank regarding Northwest Biotherapeutics (OTCQB: NWBO). DrugBank typically includes detailed drug information, including chemical structures, mechanisms of action, and regulatory statuses. However, Northwest Biotherapeutics' lead product, DCVax®, is not currently listed in DrugBank.
The building looks modern and impressive—definitely a positive for Advent. From what I’ve gathered from a few posters here, LP owns Advent as a company, but the facility itself is owned by NW, and the staff are being paid through NW's payroll. Longs, can anyone confirm this?
What’s wrong with listening to someone’s perspective? Aren’t we mature enough to discern what might be right and what could be wrong? How is he any different from some posters here who constantly write negatively about the company, and jump at every chance to hype another company, while putting NW down in the process?
We all understand that if approval comes through, the company has a strong chance to succeed, and many of the concerns we’re discussing now may not even matter anymore.
Ask questions—but also do your own due diligence. Don’t take anything at face value unless it’s backed by truth.
thanks! do you have any insights on MHRA rejections? Would a rejection typically occur early in the application process? Also, if companies sense that approval might not be granted, do they usually choose to withdraw their applications instead?
Galzus, what are your thoughts on NW receiving MHRA approval? It’s been over 16 months since the submission—any idea what’s causing the delay?
According to the findings of the TVOP analysis: in 6 business days
I gave a specific date (5/6/25) after which our application would officially be in unprecedented territory. I stand by that date as a point at which I personally would begin to feel worried about how long it was taking (even though, since that time, mRESVIA received approval with an even longer timeline).
Regardless of whether she's invested or not, there’s a big difference between an ordinary person raising questions and a Member of Parliament questioning the MHRA. Even if the answer ends up being the same, the pressure is different. These kind of inquiries are more visible, and the MHRA may feel a greater sense of responsibility—or even some irritation—because they’re harder to ignore.
Sometimes, unfortunate things happen when the timing just isn’t in our favor. All we can do now is stay hopeful. (It’s a bit like trying to impress an interviewer by answering questions they haven’t even asked—just to maintain a ‘good boy’ image.)
NWBO was so stupid, reckless, and short-sighted that they submitted the new PIP trial design to the MHRA before the decision on the MAA was finalized.
That would almost certainly trigger the MHRA to review and approve the new PIP design first, which could delay the ongoing MAA review process for months...
+ In my opinion, if the MHRA believed the compassionate care program wasn’t benefiting patients, they should’ve suspended it. Why allow patients to spend so much money on something they consider ineffective? Running a confirmatory trial isn’t easy, especially with such a complex trial design.
I disagree with that theory. If it were true, I don’t think MP Owen would’ve raised the query in Parliament looking for a definitive answer. What if the MHRA ends up irritated, realizing that NW’s management is indirectly applying pressure through a Member of Parliament?
Thanks, DD! it really brings some relief. We’re familiar with how the FDA handles rejections, but we’re less certain about MHRA’s typical approach. If MHRA were going to reject the application, it probably wouldn’t be taking this long, right? And in many cases, instead of a direct yes or no, companies end up withdrawing their applications once they realize their chances of approval are low.
Honestly, I’m exhausted by all the hype around the CHM meeting. In my opinion, the meeting has likely already taken place, and now the company is just waiting on MHRA’s decision
I still can't wrap my head around the stock manipulation over the past week. It surged without any news, only to drop the very next day. As we suspected, MP Owen likely contacted NW’s management before raising her query in Parliament. That suggests the prolonged silence and lack of decision is frustrating even for NW, and with the uncertainty around the approval, they probably feel stuck. Honestly, I’m feeling pretty nervous too.
Why do you think it’ll take that long? If there’s a strong reason behind it, please do share—I’m genuinely curious.
Without any solid news, it’s tough for the stock to hold these price levels. Considering the volume we’ve seen over the past four days, we really need either an approval or some positive update to push this to the next level.
Only four more weekdays until the Apr-2025 wraps up.