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Beartrap - Since we're talking "spin", might as well include Gordon Lightfoot's Spin,Spin,Spin. Seemed appropriate.
Gary, maybe Les was being conservative, but I thought his comments were specific enough to justify adjusting expectations for approval to the last half of the third quarter. Anything sooner would be a welcome surprise.
Two opinions, two options. Either possible, but can we eliminate a third, that a RFI was requested but is yet to be fully addressed. Between the MHRA procedures and the company's norm of remaining silent on many things, do we really know? I'm reminded of the young teenager at her group's pajama party when asked if she had any questions about sex, replied "I don't know what I don't know". Seems to me that's pretty much the position we're in at this point with regard to the MAA progress.
Gary, I have to admire your continued optimism and positivity, especially considering your age and the health challenges you've had to deal with. I'm your age, but my challenges have been minor compared to yours, but I find myself less patient or forgiving than before, one of the reasons I check on the board less. Too much speculation and opinions offered with little fact to base them on. My expectations are limited to things I reasonably believe should happen this year. First, hopefully the FHMA approval, probably in June or July. Second, upon FHMA approval, immediately filing for approval EMA and FDA approval, decisions hopefully by year end but probably early 2025. Lastly, EDEN completion and filing for approvals sometime in the 2nd half of this year, but approval could slip into 2025. I don't expect anything from the lawsuit until 2025 - the law moves too slow, too many possible appeals and actions, and no incentive for the MMs to settle quickly. Won't speculate on the impact on share price on any of these things, but hopefully considerably higher. Don't see any sense in speculating on any of the other possibilities discussed by some.
I do keep some shares in one account available for lending just to track the action. They were lent out about a month ago but returned this week. Don't know if that signifies anything, but interesting.
Your input is appreciated as always.
Huge quarterly report. Trading up 35 after hours.
Fine, you don't like Cramer, I got it. Yes, he gets excited on a topic and talk over or disagree with the hosts (usually David, but Carl on occasion). Yes, he has occasion to try and talk 95 wpm in a 65 zone. All part of his schtick to sell his act and get clicks for CNBC and his afternoon show. Entertaining, yes. You see him as a doofus, I see him as someone that often has good, if flashy input, and on occasion will do an interview or mention a stock that is interesting enough to do additional DD on. As far as timing a NWBO purchase, good luck. I agree you need to be careful of a bounce after MHRA approval. My position is pretty well set.
It would be a mistake to confuse todays Cramer with the Cramer who often shorted stocks when he ran his hedge fund many years ago. He's relatively conservative today, most of his personal holdings are now pretty conservative, and the stocks in the portfolio he runs for the show are mostly larger well-known ones. I suspect the return on it are maybe not great but will make the follower some money. His interviews and comments can send stocks higher, but often because the market is moving them higher. I'll watch him because on occasion he does do an interview on a stock I find worth checking into. Not a show for the get rich overnight crowd, although his recommendations on stocks like NVDA, LLY, etc., have been big winners. Cramer has made it plain he has no interest .50 cent biotechs, so I'm not sure why his name would get Droid excited. CNBC's useful to watch to help track the overall market but you still need to depend on your own DD.
attilathehunt
Received a Schwab message late today the interest rate on the loaned shares jumped to% to 6.5%, reflecting an increase in demand.
Charles Schwab
Income rate changed
April 05, 2024 | your account ending:
Income rate has changed on your loaned security(ies)
The income rate has changed for the following securities loaned to Schwab through the Securities Lending Fully Paid program:
Security Name Security ID Old Rate New Rate
NW BIOTHERAPEUTICS NWBO 3.5% 6.5%
Income rate changes for a loaned security are most frequently due to fluctuations in the supply and demand for that security.
You can view a complete list of securities you have on loan to Schwab at schwab.com/SecuritiesLending.
Thank you for the opportunity to serve you. If you have any questions or need assistance, please call us at 877-793-8872, Monday through Friday, 8:30 a.m. to 4:00 p.m. ET. For clients of independent investment advisors, please call your advisor directly, or call Schwab Alliance at 800-515-2157.
Regardless of how you saw my reply, I agree with the contents of your original post.
Thanks for the response, Gary. I'm more conservative on the MHRA decision, believe it will be later in the second quarter than April, figuring late May to June.
Flipper, I'm aware of how the process works. I know that lending shares has been compared to treason by some members of the board, but I consider lending them a valid strategy for the lender. I believe the share price will increase as we approach the MHRA decision date and see little benefit in letting them sit when they could generate a little income for me. I don't hold enough shares available for lending to have any impact on the share price.
Gary, I believe I remember you had mentioned that you had shares lent out last year. I had a similar situation, but the shares were returned in November. No activity since until today when Schwab notified me that they'd been lent again. Wondering if you'd had a similar situation recently, and if so, what your take is this close to the expected MHRA decision date?
Wasn't aware you had gone under the knife again. Hoping for the best and glad you're pain free.
I remember Silky. I was in high school at the time. Great horse, noted for lagging the field and coming from well behind to win the races.
Gary, I have heard that story, although as I recall his billable hours would have made him 150 years old.
We are too litigious, sometimes I think of the legal industry as the attorney's full employment act. Part of the reason is the way insurance works. claims have become just a method to transfer money from one party to another. Most will get settled short of having an attorney involved, and others have attorney involvement, but as I recall about 90% settle short of litigation. My own experience is that most settlements with attorney involvement settle even though they may be questionable. Two factors, first to limit legal costs, which will pile up quickly, and second, to eliminate uncertainty. After all it's not personal, they're moving money. And of course, the attorney(s) always get paid.
I can appreciate your friend's auto experience. I was involved in an accident a couple of years ago. My fault, and I admitted it. Both cars were drivable, and we pulled over and waited for the police. Nice people, a son in his late 20's and his mother. Checked and while both were shaken a little, they said they felt fine. Until I found out months later that about $35,000 in medical bills had been claimed, kicking the total above the underwriting limit that resulted in my policy of many years being cancelled.
Did have to retain an attorney once to threaten suit against my homeowner's policy. Theft from my garage, probably about $8,000. Thought I had agreed with the carrier, sent me a proof of loss they had prepared agreeing to the amount. Signed and returned it, and then the carrier denied its own settlement. I pointed out that by doing so they were acting in bad faith and obtained an attorney. Long story short, the carrier agreed to settle short of litigation for mid 6 figures. Wasn't happy I had to do that, but denying their own agreed settlement amount is one of those that just isn't done.
Gary, I'm not an expert either, but I had occasion often over the years representing my employer while dealing attorneys and the law and believe that hyperopia's estimate that it may be late summer before the matter is in the judge’s hands is if anything a little optimistic. Defendents have no incentive to move forward or expedite at this time, if anything delay works to their benefit. Stalling is a common legal strategy. Streamlining would be nice, but I don't see it happening until the day lawyers see it would benefit them financially.
Good luck buddy. I'll light a candle for you.
Gary, I believe you actually meant AVXL.
Showing off that grade school vocabulary again I see.
Have to admit that's (Monte Carlo valuation formula) a new one on me. Pulled up the information on it (below) but possibly someone could explain why a standard valuation method wouldn't suffice for the 10K filing.
Monte Carlo valuation is employed in the valuation of convertible financial instruments for several reasons:
Complexity of Convertibles: Convertible securities, such as convertible bonds or preferred stock, have intricate features that make their valuation challenging. These features include conversion options, call provisions, and varying interest rates. Analytical methods may not provide accurate results due to these complexities.
Stochastic Nature: Market prices can be volatile and unpredictable. Monte Carlo simulation accounts for this uncertainty by modeling various possible scenarios. It generates a distribution of outcomes based on random sampling of inputs, allowing for a more comprehensive assessment of the instrument’s value.
Exotic Features: Convertibles often have unique terms, such as conversion ratios, conversion prices, and call schedules. Monte Carlo simulation can handle these exotic features effectively, whereas analytical methods may struggle to incorporate them.
Risk Assessment: Monte Carlo simulation allows for risk assessment by considering a wide range of possible outcomes. It factors in market fluctuations, interest rate changes, and other uncertainties. This comprehensive approach provides a clearer picture of the instrument’s value.
Customization: Monte Carlo simulation is flexible and customizable. It allows analysts to vary risk assumptions, model different scenarios, and adapt the valuation to specific assets or portfolios. This adaptability is crucial when dealing with diverse convertible instruments.
Lack of Analytical Solutions: In many cases, analytical solutions for convertible valuation do not exist. Monte Carlo simulation becomes a practical alternative when traditional methods fall short.
However, it’s essential to note that Monte Carlo simulation has limitations. It cannot account for extreme events (such as financial crises) that may impact results. Despite this, it remains a valuable tool for assessing convertible securities in a dynamic and uncertain market environment
Appreciated. Thanks.
Beartrap, can you point me toward where Les indicated Canada would be next approached after MHRA approval? My belief has been that the EMA would be the next logical step. Thanks
I reckon in the end any song only has to make sense to one person - it's writer.
Gary, I wasn't serious about the shoes, although I did find it interesting that the celebrity shoe craze has now moved beyond the BB star shoe craze and has apparently now moved into other areas. Thought you might enjoy the attached samples. Wonder who the next line of celebrity sneaks will come from? Anyway, when I retired I had about 30 company logo polos collected over the years. Put them all on hangers and dropped them off at my last regional office. Hopefully they were put to use by some newer employees, saving them a few dollars. Can always hope for company polos sometime in the future,
l think webcasts should be a requirement, not an option. Company officers should have to at least speak about developments, successes, and failures, instead of relying on 30 or more pages of attorney vetted literature to cover them.
Gary, I doubt you'll see a webcast this time. I would be nice, even if the presenters didn't take any questions afterward. Sometimes the presentation itself can give a clue or you can pick up something from their voice inflections. The polo shirt idea is interesting but let me suggest a more expensive if maybe off the wall idea. The hot items lately seem to be personalized BB shoes. The Phoenix Suns Devin Booker came out with his edition the other day and it sold out almost immediately. It's even spread further. On the news this morning Trump has brought out a personalized BB shoe and it sold out immediately. Thought it was kind of ugly, but I'm a New Balance guy. These would be a lot more expensive than polo shirts, but as long as we've waited maybe we deserve a little more. Or maybe one of the board posters have a fashion flair and could design a shirt.
https://footwearnews.com/shoes/sneaker-news/devin-booker-nike-book-1-mirage-release-date-february-2024-1203588042/
https://www.msn.com/en-us/news/politics/video-sneaker-cons-reaction-to-donald-trumps-shoes-is-going-viral/ar-BB1itpq9
gary, conference calls are not specifically required by the SEC for either quarterly reports or the ASM.
Alpha, you can make that suggestion to the company if you haven't already done so. There are around 46 million shares currently hold short legally that we know of.
If there's nothing in Malik's agreement with the company that prevents it, loaning shares out is a legitimate trading strategy. Malik aside, I've seen comments from a number of posters critical of any shareholder that would do so, implying that they're somehow holding back the company. I don't agree. If you're a longtime holder, why would you not consider taking the opportunity to get some interest while you wait for approval.
Alpha, there lots of different types of tax liabilities - federal, state, local, property, etc. The sale doesn't necessarily have anything to do with shares that may have been loaned out to shorts. That's appears to be your thinking but without any support its only suspicion, nothing more, although you've managed to turn it into an implied accusation. He could have sold a month earlier for about 15% higher. Couple of other factors during the 4th quarter. First, the company created its own issue with confusing PRs and delays in getting the submission completed and submitted, and the interest rate on loaned shares was dropping pretty quickly. There are a number of factors that went into the price drop during the quarter. Don't see that his sale, even if it was done for the theory you espouse was responsible for or contributed to it.
They are good, but that doesn't mean one should apply the same logic or line of questioning to the Malik sale.
Alpha, trying to follow the logic of your posts today, I have to conclude you may have been reading too many David Baldacci mystery novels recently.
Well, Alpha, Navid has been a director for nearly 12 years. I suspect over that time he has accumulated a number of options/shares rewards. You can do the homework to look that up if you want. You might be able to use AI to do so. As to what he has done, here's his bio.
Navid Malik
Position
Independent Director
Tenure
11.8yrs
Age
54
Compensation (per year)
US$150.00k
Company Ownership
2.05 %$ 13.4m 24.2m shares
Profile
Dr. Navid Malik, Ph.D., serves as Executive Director and Head of Life Sciences Research at The Life Sciences Division Limited, Research Division. Prior to that, he served as the Head of Life Sciences Research at Cenkos Securities plc. Research Division from January 2012 to December 2015. Prior to this, Dr. Malik served as the Head of Life Sciences Equity Research at Sanlam (Merchant Securities Limited, Research Division) and Merchant Securities Group plc since September 2011 to January 2012. He was the Partner and Head of Life Sciences Research at Matrix Investment Banking Division, Matrix Group Limited from December 2008 through September 2011. Dr. Malik served as the Senior Equity Analyst at Collins Stewart plc, Research Division from January 2005 to September 2008 and also served at Williams de Broë, Research Division, covering the pharmaceutical, chemicals, healthcare and biotechnology sectors. Dr. Malik was a Senior Pharmaceuticals and Biotechnology Analyst at Wimmer Financial LLP from September 2008 to December 2008. He serves as a Director of Northwest Biotherapeutics, Inc. since April 2012. Dr. Malik has deep experience in the life sciences industry, advanced manufacturing and corporate operations and governance. He was awarded two StarMine analyst awards in 2011, ranked as the number one stock picker in the European pharmaceuticals sector and the number two stock picker in the United Kingdom and Ireland healthcare sector. Dr. Malik holds a Ph.D. in Drug Delivery within Pharmaceutical Sciences, a M.Sc. in Biomedical Sciences Research, B.Sc., joint honors in Biochemistry and Physiology. Dr. Malik holds an MBA in finance from the City University Business School, London.
Well ex, I'll give you this much. If nothing else, you are consistent. Wrong, but incredibly, incredibly consistent. Still the same old tired argument. Question for you. Once the MHRA approves the DCVax-L MAA, will you argue that they are wrong too, or just drop back to predicting that regardless of that result, none of the other regulators will approve? Just curious.
Excellent post. Should be required reading for everyone on the board.
So asking for clarification on the EDEN process makes him a fudster? If anything, Gary is one of the most optimistic posters on the board. Your loss if you put him on ignore.
Hopefully the company is right and while I don't consider myself a doubter, EDEN will be a first of its kind device, and in my experience, regulators are usually hesitant to accept new medical devices without some clinical support. And then there's the question of how regulators that "substantially" terminology will impact them. If I were the company, I'd approach the regulators with the EDEN question now. If none required, great. If required, won't be a surprise several months from now, and the company can begin to plan accordingly. Plan for the worst, hope for the best.
Gary, I think that's a pretty good estimation of the timeline for manufacture and testing of EDEN. One possible question I did see in the email was the products manufactured through Flaskworks were "substantially comparable" to those made through the manual process. Will "substantially" meet the regulators demands? That's yet to be determined.
That aside, I wouldn't hold up any regulatory approval requests on DCVax-L while waiting on EDEN. It'd have to be submitted separately to the MHRA anyway, and DCVax-L approvals by themselves should benefit the share price.
SEC Reporting Obligations
Section 13 Obligations:
Beneficial Ownership: If a company directly or indirectly beneficially owns more than 5% of a class of voting equity securities in another listed company, it triggers reporting requirements under Section 13(d) of the Securities Exchange Act of 1934.
Discretionary Accounts: Additionally, if a company manages discretionary accounts with equity securities trading on a national securities exchange and an aggregate fair market value of $100 million or more, it must report under Form 13F.
Large Traders: Managing discretionary accounts that purchase or sell NMS securities (exchange-listed equity securities and standardized options) in specified quantities also requires reporting under Form 13H1.
Section 16 Obligations:
Insiders: Directors, officers, and persons who beneficially own more than 10% of any class of equity security (other than an exempted security) in a publicly registered company must file reports with the SEC on Forms 3, 4, and 51.
Gary, FWIW, FDA PDUVA dates are 6 months for priority filings, 10 months otherwise. I assume that NWBO would file priority. I would hope the company also file with the EMA concurrent if not earlier. Hopefully enough can be learned from the MHRA submission/approval process to avoid a CRL following the FDA filing. EDEN is kind of a wild card. Was it included in the MHRA filing? If not, it will require a separate one. Will it be included in subsequent regulatory filings? Hopefully maybe some updated information will be included in the 10K or ASM.
Have to disagree the attorneys get a greater percentage of any trial award. Had occasion to be involved on well over 100 lawsuits representing my employers over 30 years. Some settled prior to trial, some lost, most won, some arbitrated. If this case goes to trial and there's a large reward, of course the attorneys will get more dollars based the size, but contingency fees (%) are fixed early on based on the attorney's evaluation of the case and I've never seen those changed.
Faber and Cramer just on Squawk On The Street talking briefly about Merck and how its Keytruda is being used in combo with many cancer drugs.
I remember the 70's too. As I recall, it took the best part of 3 decades to get Japanese auto quality to match US manufacturers. Granted, they have adapted and now make some fine quality cars that compete pricewise with our domestics. I suspect you could see a number of years similar to that with the Chinese manufacturers. Whole different set up with a different government system. That aside while China may be producing cars that look great, quality wise they don't match up to our domestic products. I would hate to think that we would need investments and incentives to compete with inferior products.
https://motorandwheels.com/problems-with-chinese-cars/
https://china.jdpower.com/press-release/2022-IQS
https://engineerine.com/why-are-chinese-cars-so-bad/