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I agree with you. They're diluting the stock day by day without any approval news—or any news at all. It just keeps slipping, first below 15¢, then likely down to 10¢ next. What happens after that? To all the pumpers out here—try using your brain. It shouldn’t be that hard to think it through.
We’re slowly getting accustomed to trading under $0.20, and it doesn’t bother us much to see it at 18¢ or 19¢ now. The next big shock would be if it falls below 15¢. I’m hoping the approval news comes soon and pushes us into the 50¢ range!
What’s your reasoning for the approval being delayed until June/July, especially after all the necessary inspections and requirements were completed? Are political factors at play?
My guess is that they’re probably negotiating a settlement, which might be why they haven’t diluted the stock in the past week... 😃
We’re slowly getting accustomed to trading under $0.20, and it doesn’t bother us much to see it at 18¢ or 19¢ now. The next big shock would be if it falls below 15¢. I’m hoping the approval news comes soon and pushes us into the 50¢ range!
In my opinion, it’s actually the opposite. If they announce something on a day like today, it would attract a lot of attention due to the high trading volume, especially with so few stocks in the green. The bottom line is, no one can stop the growth of a company if it receives GBM approval and is ready to conduct trials for DCVAX-Direct for all types of tumors.
honestly, I don’t pump or promote the stock, but I’ve always been optimistic that this company could be successful one day. Please check my past posts—I’ve openly criticized management whenever I noticed things I didn’t like. If I’m not mistaken, you probably enjoy these stock decline days because it validates what you’ve been saying all along and proves that other longs are wrong for sticking around. As for AF, I used to follow him 15 years ago, but not anymore. He’s become very arrogant and nonsensical lately.
I think it's due to panic selling in the stock market or some older individuals fearing a market crash. It will recover, and I believe it's mostly driven by fear.
Mike, I agree that the price dropped the following day, and the volume traded around 3.5 million, which is minimal for a stock with a total volume of 1.4 billion, especially after the disappointing 10-K. If you, I, and a few others sold our entire holdings, it would likely surpass that 3.5 million in volume.
We all know the market doesn’t react well to statements like that, but if it were having such a big impact, we would have seen a significant decline the next day with heavy volume. Even today’s volume shows that this is more of a general market reaction, not just because of the news. You're an opportunist, and your bias is clear—your post doesn't make any sense to me. You seem to thrive on situations like this to target long positions.
If that were the case, we would have seen the price drop the following day, not on a market crashing day. The news below may be disappointing, but I don’t think that’s the reason for this decline.
The Company is actively engaged in the ongoing process, and the Company has decided not to attend ASCO this year in order to stay focused on interactions with the MHRA and efforts to move forward as quickly as possible.
I think it's due to panic selling in the stock market or some older individuals fearing a market crash. It will recover, and I believe it's mostly driven by fear.
Based on the after-hours news today (tariffs), tomorrow looks like it will be another dark red day, and I just hope our stock isn't too affected by it.
The exact percentage required for R/S approval can vary based on the company's bylaws and jurisdiction.
If Linda was releasing PR's detailing what is in the 10K, the price would easily be over $1 and these guys would get 20% or less when buying compared to today's suppressed prices. I want to be clear, the company explicitly told me that institutions and large investors told them not to release news until after approval. That's not speculation, that's not what I gleaned from the conversation, that was told to me as a matter of fact. Whether you believe them is up to you.
a & b? please explain..
I'm not sure, Mani, how they actually split it—whether the patient pays directly to Northwest or if it's divided between NW and Advent.
I was reviewing the company’s P&L and balance sheet, and here are my key observations:
In 2024, they reported revenue of $1.4M under "Research and Other," compared to $1.9M in 2023, which is likely from compassionate care revenues, though I’m just guessing and not entirely certain.
As for expenses or net loss:
In 2024, the total spent or net loss was $83M.
In 2023, the total spent or net loss was $66M.
Here’s a quick recap of the balance sheet:
Assets:
2024: Total assets valued at $27M
2023: Total assets valued at $28M
Liabilities:
2024: Total liabilities of $106M
2023: Total liabilities of $75M
If you take a look at their P&L, they have $1.4M in revenue under the "Research and Other" line, compared to $1.9M in 2023, which is likely from compassionate care.
or possibly other items included under "Research and Other"? not sure
I don’t think MHRA would deny it, but they could delay it or request another small trial while compassionate care is in use.
Yes, I’d like to know that as well because I don’t agree with that point.
They may have spoken to some company, but who knows what stage those talks are at. Mentioning it in the 10-K without providing any details is likely meant to give the impression of something potentially promising in the pipeline.
Honestly, I really want and hope you're 1000 percent right, and that the stock price shoots up. However, as I’ve mentioned, seeing the slow progress over the past year—especially with the lack of approval, dilution, and the sinking price—has made me feel quite pessimistic.
250M/1.8B (total number of shares)
IMO, the only potential saving grace right now is if they settle the lawsuit and avoid going to discovery. This could boost the share price, possibly reaching around $0.30, and it may stabilize at that level until MHRA makes a decision on approval.
Until we received the 10-K, most of us believed approval could come at any time. However, the 10-K didn’t provide any new information or clear guidance on approval, only suggesting they’re in discussions with MHRA. We have to accept that approval may take longer, if they even get it, and in the meantime, we may not hear anything from the company while the stock price continues to drop due to ongoing dilution. Honestly, I’m not sure how to handle this situation for the next three months. One thing’s for sure – we’re stuck here for another quarter.
I was thinking about those two points yesterday, and his comments could negatively affect the stock price. However, I’m curious if the headlines you’re posting here are having any positive impact on the stock price. What’s the point of posting these X comments? I don’t see how they’re helping the stock price at all.
I hope it recovers in the end, as it would be a real slap in the face to AF. Although he acts like he doesn’t care, it's obvious he has a lot of ego and a grudge against the company.
Regardless, it sounds like a deal to buy Oncovir's Polyc-ICLC for trial use which would come with an agreement on commercial terms if things go well. I fail to see why the supposed -L + Poly trial would depend on the MAA outcome.
Actually, that’s very good news. If the market knows that a settlement is either happening or about to happen in the future, it could be positive, regardless of the amount.
We should find a way to reach out to management and get clarity on the following:
The Company has undertaken discussions and negotiations with a number of companies who have products that could serve as booster agents either in the manufacturing of DCVax products or in combination treatment regimens with DCVax or both. The Company has completed a License and Supply Agreement with a company for one such agent, which is a TLR (toll like receptor) agonist, and the Company is now in the process of collaborating with that Company to design a clinical trial of a combination treatment regimen. The Company has already identified lead investigators for this trial, and anticipates submitting the IND for this trial to the FDA in Q2 2025. The Company plans to announce the trial when the IND has been cleared by the FDA. The Company is also testing this TLR agonist in its internal lab research on enhanced versions of DCs, as described below.
The Company has been in discussions since mid-2024 with a different company to in-license a different type of booster agent – one that big pharma has been trying for years to develop as a treatment itself. The Company executed a Material Transfer Agreement with that company and has been testing samples of this agent in internal lab research as described below.
The Company has also been in negotiations since early Q4 2024 for potential acquisition of another company with a dendritic cell related technology. The Company hopes to complete these negotiations during Q2 or Q3 2025.
Dennis, I couldn’t sleep well last night, and I’ve been thinking a lot about the items mentioned in the 10-K, particularly regarding future developments and the progress they’ve made over the last six months. They claim they don’t have enough staff, but if you look at their P&L, they’ve spent a significant amount on SG&A expenses with no mention of compassionate care revenue, unless it’s very minimal. Can you tell me what’s new in their 10-K that we didn’t know before, aside from the acquisition of the dendritic cell-based company and the PIP design change, which is actually negative news? I’m also wondering why they delayed filing their 10-K until the last minute.
I truly believe that many longs have simply underestimated that this MAA is not that straightforward. BUT I think its a very good indication we have not been rejected so far for I personally believe the SAP has been bought in by the MHRA in the first CHM already.
1. The MAA is based on an external control arm (ECA) without access to individual patient-level data in the ECA dataset.
2. The randomization of patients from the control to the treatment arm. Yes, this was done for very good reasons, but it does make things more complicated. Also, while it may very well be that the FDA requested NWBO to do this for ethical reasons, the MHRA is not the FDA.
3. The change in the SAP during the trial. (And no, the explanation that this was due to an interim analysis — as ex claims — is BS.)
Can you please explain why you believe NWBO won’t receive approval in the next two months? What makes you think it might happen after that? I’d like to hear your thoughts.
Dennis, what are your thoughts on MHRA's delay in approval? The application was submitted 15 months ago, and we’ve heard that the 1st and 2nd CHM meetings likely took place, along with all kinds of inspections— the last one being in the third week of February. It’s been 40 days since then, so why are they still holding off on the decision?
I know this is good, but it's the same old information we're already aware of, and these new trials take a lot of time. We need DCVAX-L approval soon, or if it gets delayed, the dilution at these low price levels will never stop, and it could drop to the 15c range.
Didn't you say that MHRA would approve DCVAX-L because you believe in the science behind it? Of course, you also mentioned that the price might not rise significantly.
We're really stuck and can't sell it now due to heavy losses. I just hope some miracle happens tomorrow or in the coming days.