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for cash-strapped NWBO it would make perfect sense.
There is vivid trading in claimed damages in the legislation industry, you should know that.
ex even you have to admit that when to me and if for you DCVAXL is approved (FDA, even MHRA) large big pharma's will want to buy NWBO.
flipper could the $3 million not be NWBO selling a portion of the court ruling outcome (if positive of course) or a settlement (against a multiplier) to keep the lights on?
I think this would make perfect sense.
The answer would be that as with Cognate before it, Advent has, or at least will soon have, more clients than NWBO so NWBO shareholders cannot automatically equate visible activity at Advent with progress for NWBO any more than they could with Cognate.
In fact, my theory is that NWBO has been delaying the applications intentionally to let the combo data mature. And they will apply when they feel it’s appropriate for regulatory agencies to take a peek at.
PM only after MHRA approval they will enter in a deal with a big pharma. Won’t be long until we see MAA accepted
Ps I’m not lying
BS the FDA does allow SAP / endpoints to be amended even AFTER datalock. It’s laughable amusing and disturbing how you dont even pretend to do some sort of survey before you post you utter rubbish
You wanne bet I say its going to happen
Over 5 years from the end of 2017 to end of 2022, shares oustanding increased from 329 million to 1.067 billion.
No, you dont.
The pitfall of all pre-park bench sleepers is overestimating him/her self.
If you are such an expert on what NWBOs future will be like, why didn't you sell when the stock was at +$2 a year and 3 weeks ago when you knew the future of NWBO would be a 55-cent stock 1 year and 3 weeks later?
At the very least, the $1.7 billion will be issued and authorized.
You keep posting the current share count. All 1.7 billion will be in effect by the time revenue will take over. Anyone doing a guessing game on share price in the next 5 years, the 1.7 is the number.
Certainly what it sounds like. Just another reason to delay indefinitely.
By mid 2024 they will have sold the entirety of the shelf to fund the next Direct trial which will take priority. The can kicking and lack of guidance is just insane. And unfortunately allows speculation like this to run rampant which murders the share price because the street has no timeline or near term goals to look at.
If I had to guess then it's yesterday's NYC audience that is buying in. Hopefully we will see MAA one of these days
Anyone saying BO after submission has a head wind. Doubt they would have purchased the booth space with a deal in hand or in close negotiations.
Yes I believe EDEN is a maybe far in the future project and for the coming years its manual.
Im sticking with the official head count on LinkedIn. I dont believe in secret NWBO employees no one has ever heard of.
EDEN is not a prerequisite for approval its not what NWBO has requested approval for any time soon and its not a prerequisite for a buyout. In the coming years its manual manufacturing. EDEN has taken a back seat in NWBO's business development which is why EDEN's lead developer left last summer.
Its really not that complicated what you see is what you get.
I think that they have something like a dozen people working on the EDEN unit in Boston and Sawston. It is still the key to major future growth, being the EDEN unit.
Perhaps U.K. reimbursement will be limited in some way and that FDA and EU approvals are not expected for another 12-18 months.
it's nearly impossible to lie about what happened in future events.
Dennis
You can keep that quote ;)
thanks.
well. Its not only adding a few positions. Its adding hundreds of them in an already very tight labor market. Novocure has 1,167 employees, and Kite Pharma had 700 before they were bought. Just bought Prometheus Biosciences total number of employees in 2022 was 97.
If you would add the number of staff working at Advent(54) to NWBO (15) we are looking at 69 in total (I personally believe Merck will buy Advent together with NWBO).
Look at how long it took Advent to add 54 people to its staff. If NWBO would want to stay independent it would take many years after approval to get to a team of at least 600-700 needed to become some form of mid-independent large biotech. They really should have started building a team, on thin finances, 2 years ago.
but I'd be curious to know if NWBO, at this point in time, hired for any of the positions that would be needed to stay as an independent company.
The correct way would be for Advent to release drug to the Sponsor and Sponsor release drug to market (i.e. no conflict of interest).
If there was an announcement being put up in front of every investor's home by the Gods of the stock market and God of M&A which listed companies will be bought in the next 12 months then investing was easy and everyone would get rich.
The only question we have to concern ourselves with going forward is, will DCVAXL be approved if yes then they will be also bought out. Anyone claiming NWBO will become an independent cancer biotech giant really has to recheck reality.
do not often work as they should with this stock.
30 days after MHRA, NWBO would be acquired? That would be fantastic.
This is what I think what is going to happen for the next 1.5 years:
MHRA request for approval: SP to 90 cents. May or June
FDA request for approval 1 or 2 months later: SP to around $2 July or August
MHRA approval Oct: Sp to around $4 in the weeks after
Uplist announcement SP to 5$ in Dec 2023 MC around $ 6B
FDA approval May - June 2024, speculation on BO media SP to around $ 10 MC 15B
BO Sept -Oct 2024 for $24B, at a SP of around $16
It wouldn't surprise me if LP actually has an informal agreement for a buyout, but I'd be willing to bet the price is somewhere over $20 billion and in order to make it happen I believe that the share price ought to be at least half of what they'll be paying. I
It may, or may not require the approval of the Eden unit.
Perhaps it could even be revenue reaching a specific level. In short, the goal could be achievable this year, or could take at least a couple years to achieve.
Agreed that is a key turning point for the company
But they chose not to do that. My guess is the asking price will be north of $10 Bil.
This is my only post. BTW- Do I like the above scenario. The answer is NO. But, NWBO lack of financials have put tremendous impact on company's progress.
The combo trial is paid and done, its in the history books. We are only waiting to learn how fantastic the end results are. You don't need a CFO for that.
The point I'm making is that if you're a young and vibrant biotech, with a vision for the next stage of your company and (near future) approved biotech product and a vision for your next big medical trial you desperately need a CFO to prepare for the tens if not hundreds of millions to finance your next big medical trial and the selling and marketing of your approved product. There is zero indication NWBO is remotely interested in dong so.
I'd prefer a chief medical officer or CMO.
Mercks SP is up 25% because numbers were better than expected year over year.
There is no Merck shareholder selling or anyone shorting Merck because of some patent, Merck probably has hundreds of patents.
Merck's shareholders are not occupying themselves with any patent cliff, but Merck management is.
Look this isnt rocket science. 90% of small biotech fail and will never get any approval.
The 10% of the remaining biotech will 90% of the time get bought out.
Big Pharma lives and breathes by buying successful or semi-successful small biotech.
I am sure Merck's shareholders expect Merck to keep buying successful small biotechs with their tremendous cash position to safeguard their successful cash-generating drug pipeline.
After DCVAXL is approved NWBO will be bought Im 99% sure of that.
DC Vax is just one of many elements in the overall long term picture for Merck with respect to Davis’s remarks to Wall Street
that's a guy who gets it, until of course his wife as would mine summons him back to the table she is sitting at and they started the evening. Im starting to see a marriage patron here
heheheheheh married for 8 years now and if my wife says marriages are based on trust then it is the law lol
Consider everyone to be lying
I have very little doubt NWBO will be acquired, Im not sure if its after MHRA or after FDA approval.
IMHO it will not be dismissed and will show a failure in this article
The only item left to discuss is the "spoofing" lawsuit filed by the company against 8 of the largest market makers in the US, including Canaccord Genuity and Citadel Securities. In a statement, the latter said:
This frivolous lawsuit appears to be nothing more than an attempt by Northwest Biotherapeutics to divert attention away from its long history of governance and management failures, SEC charges for financial reporting lapses, and lawsuits from its own shareholders.
This SA commentator sounds insane right?
ooh ok.
well
The last two times he published about NWBO he was angered that there still was no TLD/JA 2 weeks later there was and then last Feb he was angered there was no MIA 1 month later there was so now he is angered that there is still no BLA/MAA. :)
Im sorry who is saying this
"shareholders such as us will continue to hope, against all logic, that this company will deliver one day what we have been waiting for nearly two decades".
N orthwest Bio: Data Is Great, But Nothing Else Is
Apr. 30, 2023 4:06 AM ETNorthwest Biotherapeutics, Inc. (NWBO)
Avisol Capital Partners profile picture
Avisol Capital Partners
Investing Group Leader
Summary
NWBO continues to slog away, with no definite date of a BLA submission.
They recently made provisions for a large dilution, took a "toxic" loan, and got a manufacturing approval in the UK.
There's progress, but it is agonizingly slow, and the stock keeps falling.
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Risk management and mitigation to reduce exposure for financial investment, projects, engineering, businesses. Concept with manager"s hand turning knob to low level. Reduction strategy.
NicoElNino
I would like to begin this article about Northwest Biotherapeutics (OTCQB:NWBO) by quoting the very first paragraph of my February coverage:
I cover NWBO because I appreciate the engagement with (NWBO followers). Enthusiasm, however, cuts both ways. Enthusiasm can make you very knowledgeable about something, but it can also produce tunnel vision. If there was no such tunnel vision, we would realize that Northwest Bio, being a public company, has a duty to keep its investors informed about the company in a timely, clear and dialogic manner, like other companies do with earnings calls. Northwest Bio has never had an earnings call in living memory.
The stock is down 30% since that time, and exactly because of this - no further information from the company since they published those outstanding results last year.
To be precise, that is not exactly true - it did publish stuff, just not what investors wanted to know. On January 6, the company published details about the Annual Shareholders Meeting held on December 30, 2022. A few key points relevant to our discussion are:
Authorization to issue 500 million additional common shares, which increases the number of authorized common shares by 50%.
Review of progress in 2022, which includes data, JAMA publication, and lawsuit - I have discussed each of these in my previous coverages.
Obtained regulatory approval of a Pediatric Investigation Plan (PIP) to support the use of DVax-L in children.
Progress on preparing the Trial Master File to be inspection-ready for regulators.
Preparation for application for commercial manufacturing license for the Sawston facility, a prerequisite for approval.
About the BLA, all that they said was that they are working on an application package, and plans to submit an application "as soon as possible" - this is probably what is eating away at the value of the stock, because normal companies do not take years to submit a BLA, and they generally indicate a timeline.
With reference to item 5, the company received a commercial manufacturing license in the UK in March, for its Sawston facility. The license to manufacture a cell therapy is rare, with only two others given so far. The license allows them to import products such as immune cells, and manufacture and globally export cell therapy products manufactured at their GMP facility in Sawston. In their latest 10-K, they give some details about capacity. They claim that they have the "potential capacity to produce dendritic cell vaccines for up to 40 to 45 patients per month, or approximately 450 to 500 patients annually."
With respect to item 1, I have noted again and again that this $528mn company with supposedly/apparently excellent data has no cash. Since they issued 500 million additional common shares, that is a big concern because that means potential dilution to a very large extent. In March, they signed a $11mn loan deal with John M. Fife's Streeterville Capital. The deal has a maturity of 22 months, and debt repayments will begin from November 02, when the loan will be amortized in 14 equal monthly installments of principal plus interest. That means, from November, NWBO will have to start paying approximately $1mn per month for 14 months to the lender. Two years back, NWBO took a similar loan from the same lender.
A year before that, the SEC charged John Fife "for acquiring and selling more than 21 billion shares of penny stock without registering as a securities dealer with the SEC." Here's what has been said about the mode of operation of these so-called "toxic lenders":
Fife has operated as what's called a "toxic lender" for many years. Microcap companies trading on the over-the-counter market typically have limited access to traditional financing. Desperate for cash, they sign on with financiers like Fife who purchase securities-usually convertible promissory notes or convertible debentures-from them. The financiers charge extremely high interest, but that's the least of their clients' problems. Upon conversion, the lenders enjoy a discount to market price that may be as high as 60 percent, and higher in the event of default by the issuer. As he converts portions of his note and sells the resulting stock into the market in a series of tranches, the stock's price plummets. That is why these kinds of instruments are called "death spiral convertibles." Eventually, the dilution caused by the conversions may force the issuer to reverse split the company's stock. Sometimes it drives the company into bankruptcy.
So, Northwest Bio has a) very little cash, and b) very little access to good loans, so c) they take a loan from this controversial lender, from whom d) they took a loan earlier, whose fate is uncertain, and e) they just allowed themselves to dilute shareholder value in future, by half, so f) the conclusion is that the cash position and dilution situation remains precarious for a company which claims to have arrived at very strong results in a cancer indication.
The only item left to discuss is the "spoofing" lawsuit filed by the company against 8 of the largest market makers in the US, including Canaccord Genuity and Citadel Securities. In a statement, the latter said:
This frivolous lawsuit appears to be nothing more than an attempt by Northwest Biotherapeutics to divert attention away from its long history of governance and management failures, SEC charges for financial reporting lapses, and lawsuits from its own shareholders.
In March, I see a note on law360 (which I cannot fully access), which says these companies have asked a federal judge to toss the suit, saying "the case fails to allege any actionable trading or evidence of misconduct." So, the lawsuit is ongoing, and it is, whatever its merit, a major distraction from the company's main business of developing and selling a cancer therapy product.
So that is it. These are what happened to NWBO recently. They also explain, once again, why the stock has been cut by half in the last few months since the data. They have no cash, and they are offering no timeline for a BLA submission. I have a few shares, I am not making a profit right now, and I will continue to hold.
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