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LL already layed the path for applying external historical placebo statistics. She presented the approach to the medical community, and it appears the fda understands the approach and the benefits and is onboard if applied properly.
Similarly, LL has addressed the rationale for the changes of primary and secondary endpoints. Additionally the revised definition of GBM (re wild indication) has been endorsed.
So the tracks have been layed and the dcvax train is coming around the corner.
When you ask? Like the song goes, she’ll be coming around the corner when she comes, choo choo!
I think we must have missed the announcement of - Let the games begin (again)!!!
Who benefits from such attacks:
- lawyers get paid as part of the settlement of class action suits, usually better than members of the class
- shorts and naked shorts who in theory would benefit from lowering the share price preferably to zero (or approaching zero in the limit - sorry, calculus joke)
- parties that benefit from slowing or eliminating the competition especially disruptees
- parties that are looking to acquire the new technology at lower to firesale price tag
- those who for whatever reason don’t want a particular company and/or management to succeed
- mercenaries whose energies are bought and paid for, including paid FUDsters
What they all apparently share imo is a disregard for the good that would come from success, especially benefit to the afflicted and their families.
If a company and/or product is poor or a scam then ok, but to fabricate and misrepresent, is reprehensible imo.
The Danish Dude really snapped me out of a semi sleeping state overnight with his “just for fun” imaginary TLD announcement!
Had to rub my eyes and take a closer look, although TDD did hint at the fun message by pointing out the future date of the imagined TLD post.
I admit it felt good for a moment, like the long wait was finally over…. We’ll,
Back to reality,
Oooops there goes gravity….
You got one shot!
Now that’s pumping a stock
Poor Man, it looks like the keepers of the board deleted my original response.
Let’s just say I’m not a fan of Bernie and Elizabeth ideas to further tax our gains and incomes!
I’m still trying to understand why my monthly social security benefits are still subject to income tax when I already paid taxes on that money as it was earned and paid into the SS fund?
I think the paper is referring to effectiveness based on the blinded results. Wasn’t the 23 months reported in the paper published in the Translational Medical Journal?
And I would say one billion more…
Come on Irene…
I’m afraid it’s a total injustice that mal intents with money and street positions can trade to each other and sell short shares they don’t have and won’t deliver all day long, day after day, year after year, with total impunity and without even a slap on the hand by the SEC.
Remember, they rob banks because that’s where the money is, and Wall Street is where the most money is, and you don’t need a getaway car. These guys would use their private jets anyway if they had to scram.
I don’t begrudge anybody making fortunes, I just want the refs to apply the same rules, but I guess I’m just naive
St Peters reminds me of Rocky!
It’s refreshing to be an underdog and kick some favorite butts on the court. Hey Stallone created quite a franchise…. Yo Adrienne!!!
Pande Noodles, has a nice ring to it.
Inspiration comes in many forms and places, even food trucks!
You might be able to swing the installation of a park bench in your office, like the way company’s support stand up desks.
Heck, you can replace the desk and guest chair with the bench as a new management tool that helps establish a less hierarchical one on one meeting environment for more open communication, and as a bonus you could pull Elon Musk all-nighters at the office on your own familiar bench!
At break times you can do inclined and declined pushups and planks on it for exercise.
Think of it, if you’re an executive you can get the deluxe real mahogany model!
So get your collaborative juices flowing and have fun at the office!
Is that what is called a whale in the stock?
How can this case even be considered?
Flip, this sounds fishy to me as in an attempt to distract, discredit, and otherwise detract from nwbo at an important time frame.
We’ve been through this sort of thing before.
Boards always determine compensation and awards of things such as stock and options and bonuses and compensation.
I’m afraid the anti nwbo forces are resorting to the law suits and bad press attacks again.
First, I’m no expert on BP manufacturing, however this site closure announcement doesn’t appear to have any relation to dcvax or keytruda.
It looks like a cost cutting move, or adjustment to quantity expected of the specific components manufactured at this Pa site.
Merck will adjust manufacturing at their other sites to produce. Pharma manufacturers do this sort of thing with an eye to cut costs or other reasons to close a location. The generic pharmas are more active in this sort of thing since costs are key for them.
I love big booths and I just can’t lie…
A coomah keytruda!
Nwbo having a big booth at asco has been business as usual, not involving some big announcement.
We can hope this year is different, with something major?
That is what I think, that the combo moderates or lessens the negatives of CarT such as cytokine storm that can kill a patient.
iclight (isn’t it ironic),
You do realize that the combo trials use dcvax with other stuff, so if dcvax is a necessary treatment in combos that perform better than mono therapies that’s huge for dcvax and nwbo?
Are any of your minions from the city of brotherly love, you know, are any Philly minions? Have they large steaks? Hopefully they won’t get burned and we’ll have a juicy return on investment!
I’ve continued to buy nwbo with any loose investment change on most trading days. Been doing this a good while now.
Also converted the nwbo shares in traditional ira into Roth ira to minimize taxes and maximize tax free growth when nwbo sp makes it’s ascent and nwbo potentially becomes a huge leader in immunotherapy!
Linda L has been presenting slides of what they’re investigating and she seems to think that dcvax-l plus keytruda plus an interleuken (IL6 or 8?) is more effective than any of the three alone, intimating this combo kills the tumor cells and may lead to a cure for GBM.
Nahhhh, you were fine…. I’m not operating at a high level today.
Acting like a night owl is catching up with me and even the megadoses of espresso and percolator coffee aren’t propping me up enough!
Time to live a healthier lifestyle especially to perhaps enjoy the spoils of an nwbo sp surge to $20B+ initially and more than $100B eventually! Am I awake or dreaming?
Oh, ok, I get it now!
Heads or tails…. I missed the smiley the first time I read your post…
Also I agree with partners managing relationships, and Les possibly saying what people want to hear, is a better way of stating what I was trying to say (deliberate statements vs unfiltered accidental statements)
- I better get some sleep instead of catching up with the board until almost sunrise, or better yet nwbo could release TLD already!!!
Quotes that make you go hmmmmmm?
(Thinking is to feet, as standing is to head, sort of a juxtaposition analogy, ohhh never mind it was an idle statement I thought was clever at about 4:30am instead of sleeping)
Just trying to say that imo lawyers are careful what they say, and if they say something it was intended and not blurting out without a filter.
Maybe I’m being too general, and maybe I’m relating too much to what I’ve seen first hand, which is usually being advised by counsel to just answer the questions concisely and refrain from volunteering any additional information that might be used against you .
Anyway sorry for the confusion!
If he thinks on his feet, then does he stand on his head?
I always wondered if Les is more deliberate in what he says publicly than it appears? He’s a successful lawyer and lawyers tend to be careful what is said.
Thanks! I thought so.
Is this a different Maverick#### distinguished by different trailing numbers in the ID?
In other words is this an imposter targeting our familiar Maverick handle to paint a negative image, or not?
I’m asking our reliable board members.
I hear there’s some luxurious park benches atop some upper east side NYC penthouse landscaped gardens!
Those are going to need $20+ nwbo stock price
That’s why it’s the number2 tool during pre-TLD analysis
There are also people who wind up in leadership positions where some are big idea people, some have vision, some are good operators, people persons, communicators, etc., and various combinations of these including the so-called complete packages.
Aging, raising a family, obtaining a mortgage and other important financial obligations change each of us as we live our lives over time.
I remember when I was a young, hot shot, engineer working with proven experienced top engineers who were my mentors. They would talk about the political aspects of their jobs and not going against the grain of their leadership, sounding pretty worried about any possibilities that arose that might curtail careers and paychecks.
Being exceedingly confident in ability and the power of being on the side of righteousness, I commented to them that they seemed overly worried especially as highly regarded, top notch technical experts.
One of the best responded to me by saying wait until you have a mortgage, school tuitions, mouths to feed, etc., and see how you feel then. Of course I later recognized how those responsibilities affect us and factor into how even the most independent of us become more “practical” in career impacting situations.
The combination of younger, energetic, smart leaders who recently graduated from learning the latest and greatest and often disruptive technologies fully applying themselves and immersing themselves in a major quest seems a fertile situation for creating new disruptive advancements and environments and products. However, among the most important things any leader needs is to know their own strengths, weaknesses, and limitations, and to find/hire/invest and surround her/himself with people smarter and more capable than themselves.
Thanks for the clear explanation and the reality of it’s unwise to complain about the entity that holds your approval in their hand! Should be added to Jim Croces song along with
You don’t spit into the wind
You don’t pull the mask off the old Lone Ranger
And you don’t mess around with the fda!
Yeah it doesn’t rhyme but I’m invoking poetic license and you best not complain, because I’ll go all fda on yo azz
Thanks Bio !
From what I gather, the fda doesn’t directly bless a SAP, however it is said that the fda will tend to identify issues/questions if something is not to their liking. Hence lack of corrective feedback might be tacit approval, however I don’t know this can be relied on, so fda might be more of a question than the overseas approvals.
Again there has been recognition among medical and approval entities of the imho sound rationales for the recent changes to the SAP.
Ultimately everything is a roll of the dice and there can be other motives and drivers for decision makers.
If you know of any sure things we can invest in we’re all ears!
Ain’t that the truth!
Seems like most kids insist on learning the hard lessons themselves these days.
Maybe I was like that too, it’s been so long I don’t remember, however I don’t think so.
GLTU and All
Nix, in the immortal words of the great Sally Fields:
“You like me… you really like me!
Thanks, much appreciated
Where do we start?
First, yes the endpoints were flipped for reasonably valid reasons as more became known for the first time during the long duration of the trial. Are you aware that the endpoint changes were reflected by the governing trial database entities in the UK and I believe EU/Germany, thus implying they are ok with the endpoint changes in the SAP.
In the USA, the trial sponsor is responsible for updating the trials database and so there isn’t as clear confirmation of endpoint change acceptance, but also no known sign of rejection. Since nwbo maintains there is one SAP then either the fda is onboard or we might have approvals outside the USA pressuring the fda but any approval is a win.
In the mean time there has been acknowledgement that tumors can enlarge while being destroyed by the immune system and better ways to discern this versus true pseudo progression. There is also acknowledgement that pfs is really a surrogate for OS and since the trial ran long enough to get good OS data and clearly shows the long tail of survival, it should be reasonable to value OS as a primary endpoint. The pfs data and more was still captured and analyzed as well.
The use of external placebo data has also been socialized in the medical community and even the fda has recently indicated support. The results across the various external placebo groups are empirically the same as would be expected since they are groups of GBM patients who did not receive the treatments being tested by the trials, and most importantly it is immoral to continue to give no treatment to GBM patients, which brings us to the crossover in the dcvax trial. The recognition of the fate of GBM placebo arm patients is what demanded a crossover, so at least a patient that progresses would have the opportunity to receive dcvax and a better late than never chance of treatment benefit.
So there it is, nes pas?
Bio, I’ve become the cliche older guy that recounts his old cool experiences repeatedly, especially since retirement.
Time to get more involved with new things and get back out in the world now that we seem to be returning towards normalcy with regards to Covid in the USA especially!
I used to lead a much more interesting life, traveling and meeting a variety of people in diverse circumstances, and then there were all the classified government work and systems that provided quite interesting experiences, but alas I now spend an outsized amount of my waking hours managing my retirement portfolio and immersed in nwbo/dcvax due diligence and thinking through the logic of success vs failure ad infinitim !
I live vicariously through you and the other fine, intelligent, and successful, co-posters on this, the best message board I’ve ever experienced, and I’ve experienced message boards from the earliest like the old IBM/Sears/(AOL or did AOL come later.) internet service which was via dialup modem at 1200 baud!
I hope my silly humor while waiting for TLD and most any new breadcrumb isn’t too annoying and off topic.
Been here a long, long time and the FUD has been recycled a few times, and LP and company just don’t leak anything! Tightest radio silence ever!
I like to think I try to be like the guy in the Rudyard Kipling piece about being comfortable with common folk and kings, and keeping your head when others are losing it, etc., one of my favorites….. “you’re a man my son.”
However, all the commiserating doesn’t translate into great wealth rubbing off on you, but as some of the old time comedians would say, “I’m comfortable”.
From what I gather there are many on this bulletin board “much more comfortable” and I suspect you’re one of them (there’s a lot of money in ramen, and you’re excellent with your noodle) and I suspect you’ve got at least one solid gold park bench disguised as stained mahogany!
John Sculley was the guy from Pepsi (you want to keep making sugar water, or come with me and change the world.)
I only met Jobs that one time and he was very personable then, however we were exploring a possible joint opportunity so we didn’t work for him.
His lieutenants appeared to have been with him a number of years and seemed at ease, however his computer/presentation guy who arrived well ahead of time to set up for his presentation displayed a healthy amount of care in set up and test to ensure problem free operation of the presentation, and it was!
The other thing that made Jobs a good guy as far as I’m concerned is that months after that meeting my software development team ran into some issues with the NeXT software we integrated into a real-time control system and I emailed Jobs about the importance of this application being successful, and without responding to my email I was reached out to by one of his software executives and they sent a VP and a troubleshooting team to NJ to work all the issues with us and obtain rapid resolutions, staying at least a week with my team!
Thanks for the patient/decision aspect, which I was never aware of previously.
Unfortunately, there are too many such stories of people opting to try alternate treatments such as dietary-only approaches, and losing the valuable time to treat properly before it’s too late.
That’s 100% correct! Arrfff! Arrfff!