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In your opinion, what will happen after approvals? Do you think they will seek a buyout or continue on with other indications? Also, any opinion as to valuation after approval?
So your analysis is to be trusted over 70 neurosurgeons? What are your qualifications?
Not sure it’s much of an elephant. The answer is never. Specials may cut into operating losses but highly unlikely that they would ever make enough from specials to cover operating expenses. Approvals coupled with insurance/government reimbursement is the only way they stop operating at a loss. However, I believe an injection from a partnership is probably how they fund the company in 2024.
What are they supposed to PR? If applications are not submitted and/or accepted, what is the purpose of a PR? Letting everyone know that applications are still being prepared? What would these PR say?
I just think he’s a frustrated long. I get it that it’s hard to wait. It would be easier if we were sitting at 1.50 instead of .50 but not really relevant in the big picture.
I’m not panicking at all. I continue to buy. I’ll wait until the end of the year to reassess my position. I don’t need management letting me know what they ate for breakfast to sleep at night.
When was the last time those prices were predicted? I’ve seen him post that .375 prediction almost daily for months now. All those “crazy predictions” take into account applications and approvals. Those prices are unlikely but cannot be judged until those events occur. I have no “agenda bias” just as I believe you don’t either.
Has it hit .375? No, so he is wrong. Don’t confuse yourself by comparing to others, his continual prediction of .375 is wrong.
Another embarrassing day for you as your .375 prediction is wrong
Genius idea. Issue a PR insinuating that the political science major’s opinion matters.
Maybe they should PR what temperature their office thermostat is too? This PR stuff is nonsense. What do you want them to PR? We are working on applications and we’re not done yet? This whole “lack of communication” narrative is one the stupidest things I’ve ever seen.
A man is running. Is it safe to assume he has two legs? Yes, because normally people who run have two legs. Does it make it 100% true? No, but there is a high likelihood that it is. Reckless would be to assume the opposite of what is normal is true. These cases are normally taken on contingency. There is no evidence indicating otherwise. Its not reckless to assume this case is being taken on in a normal and customary manner.
These cases are normally taken on contingency. Do you have any evidence that this case was not taken on contingency? If you have any evidence to the contrary, provide it.
I disagree. If they came out in the beginning of this year and said we are working on applications and expect to submit Q3 2023, what do you think would happen to the stock price in the interim? You would have millions of shares sold looking to buy back in before Q3. This probably would have caused another share price collapse. We know they are working on applications. I think it’s silly for people on this board expecting updates when everyone knows that is exactly what is going on: working on applications. What would those updates be? We are still working on the applications but they are not complete? I would rather have no communication than constant communication with no substance. I’m curious as to what communications you are looking for?
At this point, management is wrapping up applications to get approvals. Approvals/commercialization/partnerships are the only things that would provide lasting appreciation of the stock price. Would more communication help the stock price? Who knows? There’s a possibility that it would have the opposite effect or no effect. All we know is management has decided to keep communications limited and they believe that is the best course of action. In my opinion, management has very limited control over the share price in these circumstances.
If you’re wrong, you stop posting. If you’re right, I will. Deal?
I don’t think there is a correct answer as to “typical” as this area is relatively new. Part of the complexity is each vaccine for each patient is slightly different. This needs to be addressed in the application. It doesn’t make it 400x as difficult as a non personalized product but it would make it substantially more difficult.
At this point, calculations are done. I believe Les is saying they are going through a final review before submittal. Will that review take a week, a month or a year? We don’t know. I believe we hear something within the next couple months but that’s just my take on it. I’m giving them until the end of the year. I will continue to accumulate until then and reassess at that point. I don’t think I’ll be disappointed.
The BLA they are filing can be considered a “first time it has been done”. It’s a fully personalized product and not an application for a standard chemical drug. People fail to realize the complexity it adds to the application.
This might be what LP meant as being strategic. Get the rest of the world onboard prior to submitting a BLA in the US.
We can speculate all we want. I think he’s just excited about applying AI to our dataset as AI is the hot topic these days. That’s probably the simplest and most realistic guess.
The only thing he’s stating is that he sees value in the database and he believes the value should be unlocked by the company. He believes so strongly in that that he would be willing to become an activist investor.
Wr know is the company is laser focused on getting the MAA done. You’re making assumptions that the company has no plans to monetize its database and Bigger is in a dispute with them. What if management already has plans to monetize the database? Then no change of course is needed, correct? You’re just making assumptions to create conflict where no one knows if such conflict actually exists.
You seem to have glossed over the “if required” part. He will be unhappy if they don’t try to extract value from the database in the future. Specifically, after submission of the MAA. That doesn’t mean he is presently unhappy.
If you look at the first part, 3 questions were asked:
Are you still bullish?
Have you spoken with management and are you concerned?
Is it all in due time?
His response was “of course”. You have a 1/3 chance of his response responding to the 2nd question and him being concerned. However, when multiple questions are being asked and only one response is given, people are usually responding to the first question or the last question. Not a question in the middle.
His 2nd response is “so much potential”. Why can’t that be in response to “we are on the cusp of something great here”? That would make the most sense.
Also, his initial tweet is qualified with “if required.”
Nothing here points to any issue with management. You can read into it all you want. He is waiting for MAA submission like the rest of us.
This was around the time when pseudo-progression was being seen in other immunotherapy studies. The Company has stated they were blinded. To say they are lying because that’s the only theory you can think of is incorrect.
Any significant purchase would drive up the price tremendously. In theory, you could purchase 50 million shares for 28.5 million dollars. That’s less than 5% of the company and would be about 30 days of daily volume. The price would be substantially higher by the time you bought your last share. The only time I can recall a public company purchasing stock on the open market was when Porsche purchased options in Volkswagen equal to about 30% of the company. That caused an epic squeeze. I’m sure it has occurred other times but that’s the only one that comes to mind.
You’re mistaken. These are LP’s words:
Some years ago, some of you may remember, we had hoped to embark upon combo trials years ago, and we actually have reached conceptual agreement with several other parties, and we announced this to do -- to proceed with combo trials.
Unfortunately, from a resource standpoint just couldn't do it from a resource standpoint, and we had to just stay focused on getting our lead program to the finish line, right? But now that the Phase III trial is done and as soon as we've got the application for approval cemented, we're very eager to proceed with these combos. I will say we -- again [indiscernible] about the past, we will be looking for the terms to be favorable for Northwest and its shareholders.
Same thing said by who? By people on this board? The company has came out said getting this approved is their priority and are working to do so as fast as they can. If they borrow money, it’s toxic financing. If they dilute, it’s toxic dilution. No matter what they do, it’s bad in your eyes. They need funding to get to the finish line. We have to accept that it will be at 1.5, 1.6 or even 2 billion shares. If this ends up at $6 instead of $8 a share, I’m not going to cry. Either way, it will be a great investment.
No, this was from the annual meeting:
We have actually -- we actually walked away from a combo trial that we could have proceeded with before. The terms were quite unfavorable with us supposed to supply everything and receive very little. So we're not going to do that. So anyway, that's our perspective on combo trials.
Interpret the data any way want. It won’t matter. This is what 70 doctors found and so will the regulators:
Conclusions and Relevance In this study, adding DCVax-L to SOC resulted in clinically meaningful and statistically significant extension of survival for patients with both nGBM and rGBM compared with contemporaneous, matched external controls who received SOC alone.
According to LP, a partnership was presented to the company and they turned it down. They’re not going to do a partnership unless the terms benefit them.
What Thermo said is wait for MHRA approval and everything else is noise. Approval is coming. If it is tomorrow, next week or in 6 months, it doesn’t matter. I doubt Thermo is dumping at $1 when he sees the big picture.
MHRA approval alone will generate hundred of millions in revenue. It will be enough to sustain the company. We have no idea how long it takes to submit an application for this product. You can’t compare other drugs to this application This is straight from LP:
In our case, putting the application package together has some special challenges by virtue of the fact that our product is a fully personalized product, as you all know. It's not a standardized product. That means, for example, the ingredients that go into it, each patient's immune cells, each patient's tumor tissue sample has a lot of variability. So we have to deal with those kind of aspects, which if we were making [big] batches of small molecule chemical drugs where the pills are all the same, we wouldn't have those aspects to deal with, okay?
So we have some special aspects to deal with in putting our application together. We also don't have a lot of precedents to follow. There's only been one other dendritic cell product that's reached approval. There are T cell products, and they have some similarities, but they have some meaningful differences. So a lot of what we're doing is pioneering and we're figuring out as we put it together, what will it take to make the case convincing to regulators.
That actually makes sense. Thanks.
That doesn’t make any sense. If they have an approved product then they would say an MAA has been granted.
Here is a past post:
Is MAA submission a prerequisite for the MIA approval?
No, in the UK, submitting a Marketing Authorisation Application (MAA) is not a prerequisite for obtaining a Manufacturing and Importation Authorisation (MIA).
An MIA is required for companies that manufacture, import, or distribute medicinal products. The MIA confirms that the manufacturer has appropriate quality control systems and procedures in place to ensure that their products are manufactured to the required standards. It also includes information on the facilities, personnel, and equipment used in the manufacturing process.
On the other hand, an MAA is required to gain marketing authorization for a new medicinal product in the UK. The MAA demonstrates that the product meets the necessary safety, efficacy, and quality standards for use in humans.
So, the MIA is a prerequisite for manufacturing and distributing medicinal products in the UK, while the MAA is a prerequisite for marketing a new medicinal product in the UK.
MIA approval requires MAA is in the process, what does that mean in the process, does that mean the submission?
You are correct that in the UK, a Marketing Authorisation Application (MAA) needs to be in progress or submitted for an applicant to be granted a Manufacturing and Importation Authorization (MIA).
"In the process" generally means that the applicant has started the MAA submission process with the Medicines and Healthcare products Regulatory Agency (MHRA), which is the UK's regulatory agency responsible for assessing and authorizing medicines. Typically, the MHRA will review the MAA and inspect the manufacturing facility before granting the MIA.
Therefore, to obtain an MIA, the applicant needs to demonstrate that they have an ongoing MAA submission process with the MHRA, which can involve submitting the application, providing additional information, and responding to any questions or requests from the agency. Once the MAA is deemed acceptable by the MHRA, the agency can then proceed with the inspection of the manufacturing facility and the granting of the MIA.
It seems the answers contradict each other. One requires the MAA, the other doesn’t.
I understand that but that would also mean that every MIA approval requires an MAA application pending. From what I’ve read, that is not true. The application even has an option for n/a. Why would n/a be on there if MAA is required to be pending or granted?
I know that is the response you received from the MHRA, but does it matter that Advent holds the MIA instead of NWBO? From what I've read, it is possible to get a MIA license without an MAA. In fact, I pulled up the application and the question states "Do you have a pending/approved Wholesale Distribution Authorisation or other Manufacturing Authorisation" N/A is a possible answer. I'm hoping you are right, but based on what I'm reading, a MIA license can be issued without an MAA being pending/granted. In fact, the application doesn't require what specific drug you intend to manufacture. It just states the type of drug. Your guidance may be when the same company is seeking both a MIA and MAA. In this case, Advent received the MIA and NWBO is applying for the MAA. It should be noted that Annex 5.6 of the MAA application requires manufacturing authorizations to be included. I'm not so sure that the theory of the application being submitted because of the MIA authorization is correct.
I doubt that anyone knows when the submission will be considered complete. If they are in a rolling submission, the regulator is the one who determines when they have everything they need. I just went through a similar process for my client’s laboratory. Data packages were submitted and the state regulator came back with questions and modifications. This process took 20 months of back and forth. We were at “any day now” for about 4 months before receiving final approval. NWBO is probably going through the same back and forth on something much more complicated.
Another issue is the ability to actually buy the stock. As you know, NWBO is on the OTC. I have several friends that I have told about NWBO but have been unable to purchase it because they use Robinhood. There are a lot of retail investors who won’t jump through hoops to buy OTC stock.
How is it likely the share prices drops down to .40? There has not been any sustained pricing at that level in almost 3 years. It is actually unlikely it drifts down that far. As of 3/31/23, 1.4 million C shares have been issued. Applications will be submitted this year.
How in the world are you further back now than in 2018? Data lock, TLD, JAMA article and the company stating they will be applying for approval(s) this year. We are in June. The company has until December 31 to make good on their statement before you begin to assert they are kicking the can down the road. I expect it to be much sooner than December 31.
What prevents them from doing that is that the executive is violating their fiduciary duty to shareholders in that scenario. The executives job is to look out for the best interests of the company and shareholders. Selling to a friend knowing the stock is about to appreciate is clearly a violation of the executive’s fiduciary duty.
Merck is interested in purchasing NWBO. Merck would like to see unpublished, confidential data on the study. Based upon your interpretation of the law, Merck would not be allowed to see that data because it’s confidential. If they did see the data and decided to purchase stock through an offering, then you believe that would constitute insider trading. That’s simply not the case. No deals would ever happen if that was truly the law.