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Because that would violate her fiduciary duty to the company and constitute self dealing. There is more than 1 law that protects shareholders.
Good job taking a simplified answer and creating a hypothetical to try to make a point. Insider trading is rooted in violating a fiduciary duty to keep information confidential to protect the company and its shareholders. When negotiating directly with the company, such as a private offering in an arms lengths transaction, there can’t be insider trading since the purpose of the disclosure is specifically to facilitate a purchase. However, if that party took that information and traded on the open market, that would be insider trading.
It’s not insider trading if you’re buying directly from the company pursuant to an offering. Trading means the trading of outstanding shares.
This case will not go to a jury except to determine damages. The records of trades are all electronic. There is no dispute as to what happened. Northwest is arguing those actions are wrongful. The judge will decide whether or not those trades are wrongful as a matter of law in a summary judgment motion. Only factual disputes go to a jury. As far as I can tell, no one is disputing what happened. They are disputing whether or not those actions are wrongful. If NWBO succeeds on its motion, the defendants will settle. Defendants can’t risk the jury handing them a large verdict on damages.
Thanks Grip. I appreciate the kind words, but a bet is a bet. I’ll be back in a month. Hopefully we’ll be taking dollars instead of cents. Happy holidays!
According to LP, the MIA is a prerequisite to submission. See below:
So that's where we are on the commercial manufacturing license, inspection done and post-inspection steps far along. Question number three, kind of more to answer this. What's the approximate timing for filing an application for product approval and what kind of timing might regulators have. We, of course, can't predict it or there's certainly not control the timing of regulators. But as I've said, an application for product approval is our top priority and laser-focused.
We plan to file -- we have to get the commercial license first when I was just talking about. That is a prerequisite before being able to submit the application like the PIP, the pediatric investigation plan was a prerequisite. We had to get that done. So we have to have that. But our time line is to file as soon as we can. And we also plan to be strategic about filing in multiple places.
Almost Grip. Low of the day is .6901. I’m hanging on by a thread haha
Posts like these are why I continue to read this board. Great job!
You’re right. Probably won’t see much of anything. Would be interesting if they filed a summary judgment motion though. Our opposition could potentially have some interesting things attached as exhibits. Will be interesting to see what happens with this next year.
You said “Being on OTC with no institutional buying” implying that institutions were the one causing the squeeze not retail.
Not sure NWBO could agree to confidentiality. Any settlement would probably be deemed material and would need to be disclosed on an 8k
To a certain extent you’re right. I haven’t been around as long as you. However, the bull thesis was alway great data with the end result of approvals. We are still on that path although it’s taking longer than anticipated. If you remember, the popular bear thesis was data would not be released. Also, denial would never occur because they would never apply. I’m looking forward to the day when I start hearing “it’s approved but no one will buy it’”.
Nice to see the bear argument has now shifted to “they won’t get approval until 2024”. We’ve come a long way from “we will never see data.” Late 2023 or early 2024 doesn’t really make a difference. Even the bears are agreeing applications are forthcoming.
Do you think institutions caused the AMC or the CVM squeeze? Pretty sure that was all retail.
Only if they decide to do a stock split hahaha Ridiculous statement after everything we heard on Friday.
It’s very realistic for it to hit $5. This is undervalued at this point. In my opinion, we should be at least $2.50 a share right now. Throw in 1 approval (MHRA) and a submitted application to FDA, this will hit $5+. Assuming FDA approval this year, we should get to $8-$12, depending on outstanding shares.
There are a number of defenses that may be brought up in a motion to dismiss but the only one that would matter in this cases would be a “failure to state a claim upon which relief can be granted”. Essentially, for purposes of the motion, the Court would have to accept all allegations as true and decide whether they constitute a cause of action under the law. Unless there’s a chance to completely dismiss the case or a cause of action, it may make sense to bring up defects at a later date. Some attorneys file them as a mechanism to bill. Either way, these motions have to do with technical pleading defects. Even if the Defendants are successful, the Court usually allows the Plaintiff an opportunity to amend. It just causes a delay. I don’t think it’s a foregone conclusion that a motion to dismiss gets filed. An answer may be more appropriate.
This lawsuit is very likely to be resolved in terms of years not months. The most important thing is that it will hopefully stop these types of trading activities from occurring.
Updates were good enough for me. It’s a stock. If you’re not happy, sell.
The longs did ask and she didn’t mention anything. The nothingburger ASM? Updates were given. What else were you expecting?
I agree with you. I don’t think the partnership would include any equity at this point.
Potentially or they could do a much smaller deal. Even a small 100 million dollar deal provides NWBO the runaway to get L approved and fully commercialized with no more dilution. This also give the Company legitimacy as they now have a BP partner. I’ve said this before but I think BP has a vested interest in getting L approved. L is not a cure, it’s part of a cure. Look at the Keytruda combo interim results. They look great so far. A Keytruda approval in GBM is worth 1-2 billion in the US alone per year. I can’t imagine Merck not wanting L out there just for the potential combo approval down the line.
I don’t believe the partnership will involve an equity stake in NWBO. Potentially an option that allows the partner to take a stake in a future offering. SP is too low for the company to offer equity now.
I agree. Questions were submitted regarded any potential partnerships and LP did not answer them. She briefly glossed over a combo trial proposal that they found unfavorable and did not pursue. Either there has been no discussions with BP or LP just decided to avoid answering those questions. I believe partnerships will be forthcoming and discussions are underway. Previously, I thought they would be for Direct and or prostate. I’m backing away from that and, instead, believe they will be for L for indications other than GBM. Manufacturing will be a prerequisite to any deal. I think we’re only a few weeks away from that. We should see some exciting news the 1st half of next year.
That hasn’t happened in the past 6 months. They’ve sold C shares which are basically a block of common shares. Where have you seen any indication of more warrants being issued?
As a follow up and proof that the comparability study can be part of the original application, look at page 4 of the FDA guidance document. There is no question NWBO is already gathering the EDEN data to submit in the original application.
https://www.fda.gov/files/drugs/published/Comparability-Protocols-for-Human-Drugs-and-Biologics--Chemistry--Manufacturing--and-Controls-Information-Guidance-for-Industry.pdf
That is incorrect. They submit all the data they have accumulated along with the the comparability study. The company explains how they did type comparability study and provides the data. The RAs can choose to accept it or may deny it and require a further study.
Where do these ideas come from? There is nothing to indicate toxic financing or dilution is coming. They will continue to dilute in the same manner as the past 6 months to continue operations.
I’m not sure anyone should be shocked but what they heard. It’s a great update. Waiting on certification of Sawston before filing applications. We should have news of application filings within 6 months. They have been approached by BP for a trial but won’t take a bad deal. I heard nothing that frightens me.
Hasn’t hit .69 yet. I wouldn’t count your chickens before they hatch….
4pm halt. Rumor is the halt will last until Tuesday haha
Technically, NWBO isn't part of the combo study. Enrollment began in January 2020. I'm sure there was some COVID delay. Interim results did come out this year but I believe it wasn't that long ago.
They both use dendritic cells and have similar mechanisms that may be worth exploring in combination with Keytruda or other drugs. The objective has shifted from there needing to be a clinical response on its own to does this product make x drug more effective.
I don't think the JAMA article is the big thing. I believe it is the combo data is what will drive the value to pharma plus the ability to manufacture. Would you be more interested in getting a new drug out to market or getting the blockbuster drug you already have an extended patent life along with potential approval for multiple other indications? The value to Merck is driving Keytruda sales up.
The combo data. In 2015, Keytruda did not exist as an approved drug. You don't think Merck would spend some money on potentially expanding Keytruda's use?
These deals take time to materialize. I would imagine something like this would take a months of negotiations to get signed. That's why I believe something will occur within the next 6 months. To clarify, I believe the partnership(s) will only be regarding Direct. They will be moving forward on L alone. Money from the partnership will be used to set up Direct trials and get L fully commercialized. The partnership(s) will not involve any company immediately taking an equity interest in NWBO. I don't believe any capital is being spent on the lawsuit. I am fairly certain it is being done on contingency. There are several reasons to defend the share price. Again, everything I'm saying is pure speculation on my part. I'll look back a year from now and see how accurate this is.
I agree completely as to L. However, I think we get a partnership on direct before end of Q2. Merck will have an interest in getting L on the market based on the interim results of the combo trial.
The FDA should be satisfied with a relatively straightforward comparability study. I think a distinction needs to be made between a fundamental change in the process vs the automation of the same process. My understanding is EDEN does not change the process, it just automates it. The justification for the changes is the EDEN system is “closed” reducing the risk for contamination and human error.
Do you really think they wasted all that money at ASCO, with the financial condition they’re in, to present technology that’s years away? EDEN will be implemented in 2023.
I am not familiar with the MHRA process. My understanding is the FDA will require manufacturing as part of the BLA. Hopefully they provide some clarification either way.
Pretty sure the delay on the applications will be manufacturing and implementation of EDEN. Hopefully they let us know.