Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Thanks for this Danish Dude.
My favorite is this one
“We don’t get paid for activity, just for being right. As to how long we’ll wait, we’ll wait indefinitely.” Warren Buffett
There is only one Buffett in this world, although truly it has always been Buffett and Munger.
I just have to say this before getting back to my family. I think most people here have the wrong impression of how things get done inside a BP.
Decisions and strategies are made by middle management. People who work in industry are mostly concerned about themselves first, patients second, their drug third and company last. We all believe in the drugs we support, or at least the vast majority of us. We are all free agents for the most part and it is a smaller industry than people think. Your reputation travels inside industry and among physicians. A long tenure at one company is the exception, not the rule. Most of us are loyal to each other and our physicians, not the company. Companies screw people all the time and we have all seen it happen more than once.
You can be greedy and have good faith intent…I think that describes most of us longs.
I asked questions and provided caveats…
BTW - words have legal meaning. Therapy means treatment. If they wished to advertise a platform technology to patients at the ABTA, they should not have put the words together in space and time.
Brain Tumor…DCVax(R)…and Immune Therapy together in one advertisement.
Does this help clarify for anyone the meaning of that advertisement?
If you were a patient about to undergo surgery to remove your brain tumor, would you pay out of pocket to properly prepare and store the tumor for future use as LL has suggested should be considered?
Those are resources your family desperately needs, especially if you are the breadwinner of the family and your only life insurance is provided by your employer or you have none at all.
I am on vacation with family attending places that require tickets and exhaust you. So I am not reading this message board or replies to my avatar.
I understand that a similar tote from a previous (2018) SNO was reported here. IMO there are two very big differences between then and now. First, the registered trademark symbol is missing from 2018. Second, NWBO had an active trial open in 2018 and they do not anymore as of 10.5.2020. Before anyone jumps on the UCLA combo trial, it is just that a trial sponsored by LL and the UCLA, not NWBO. There are no active US trials sponsored by NWBO..
Also, regulatory scrutiny over premarket practices dramatically increases once you initiate the process towards approval. If the BLA is rolling, my opinion would be that started when the database was locked. If this is a more standard submission, then it may be that nothing at all has been filed and fear of reprisal remains low.
A question for Senti and others…if DCVax-l (or its alternative name DCVax) is a platform technology and not a vaccine drug therapy, then what exactly is the drug? It seems to me that each individual batch is unique, so it can’t be at the batch level or that would require 6.5 billion BLAs to treat everyone on this earth or 325 million BLAs if we focus on the US market. Not sure how you would test efficacy in each of those, or recover a fee for delivery of the product. Recall also that the ABTA ad says Brain Tumor on the page so, I believe that clarifies which version of the process they are referring to when they call themselves an immune therapy. To laymen, lung cancer is lung cancer it does not matter what cell type and brain tumors are brain tumors.
I have a lot of angst about all of this too. As with all legal arguments, it is subject to interpretation. But unlike most legal situations, it is not a judge or jury of peers that decides. It is FDA.
Now, I must go and may not read a single post until Sunday evening.
Jack, regardless your opinion…high risk without FDA approval to do so.
It does not matter what DI thinks, only FDA and their competitors who can and will issue a complaint. Or me, I can issue a complaint too, and you understand what that is called and why one may do that don’t you?
That is 2000 counts, not 1.
Let me rephrase for you E) ignorant judgement of marketer’s preferred choice
Look up the rules for SNO…you have to follow FDA regs and they use pens as an example
It is a marketing channel for Absolute FACT, no different than a billboard ad or a journal ad. And advertisement is an advertisement and the vehicle does not matter.
It could be that plastic screen in your urinal that you leak all over as you read their ad. It is still an ad, and that one is also brilliant.
Then they should not have premarket promoted their One Product that is supposedly part of a platform technology going by the same trademarked name to the specialty that will prescribe that One Product, if approved.
How do you think Novacure will react to that or do you think FDA only takes the side of the newest development? What about Roche, that Belgian company and the other companies investigating rGBM products…does the harm in premarket promoting done to them and their mission not matter to FDA?
You all are the crazy misleading ones. You all think FDA cares about minor technicalities, bait and swith or illusionary tactics…they don’t. They call a spade a spade and their definition of a spade is what they choose it to be and they tend not to be conservative with that definition.
Let me put it to you another way, if they did not seek FDA approval on that bag then we may have a very, very big problem with our application….like sell to Merck for pennies on the dollar big.
Do you think LP would take that risk…now of all times, now?
Okay Snoopy, I think that is actually “B”. You believe dropping the L makes it a platform despite them saying otherwise.
Is Humira a platform technology?
You can’t call Humanized Monoclonal Antibodies a platform in the same sense that it is being applied to DCvax because each one does use different manufacturing steps. That may be called a platform technology, but it is not at all similar to DCVax. DCVax uses they same process every time or at least we assume that. They are only testing ONE Product for the past six years…no one would confuse that ONE Product for the Platform, because that is what actually matters.
What is your intent in promoting it and would it be confused by the consumer of that promotion as promoting an approved product or one that is coming soon?
Humira has approval in like 22 different indications, makes about $18-22B after rebates in those distinct diseases, and uses the same manufacturing process every time they produce a batch
Vendors with APPROVED drugs, not vendors with a pipeline product. That I can guarantee you DOES NOT HAPPEN all the time. I’ll have to ask one of my friends to search for the penalties to see how often that happens, but I am pretty sure it is NEVER.
Senti, I previously had your vote down for “B” but now it seems you’ve shifted to “A”. I vote for “D” as well as Flipper, CassieW, and it seems Biosect. Everyone has their own opinion here, and mine may not be right. Although everyone is entitled to an opinion, only one of the below answers is correct and we do not decide…FDA decides.
Right Davew2 because normally it should be about 2 weeks to analysis, 1 month to draft, 1 month to circulate among authors, and 6-12 months from submission to acceptance. Let me add that up….8.5-14.5 months.
Now we are at 13 months…hmmmm, how much to add for complexity?
Since LL presented the shell of the hybrid database construction in April, I think it is safe to assume the paper was submitted a month or two after that, but since I think it will be closer to 8 months from there, I predict early January (15 months). So yea, we should be a little bit delayed.
They just did communicate and yes, the channel was just a tote bag, but what that bag says is that a certain approval is pending.
Were the atoms in the first H-bomb just atoms or did they send a historically huge message?
Slipping a postcard in the tote bag and then UPS mailing it to every physican in the disease state….
That’s the ‘coming soon’ campaign approach I most recently used, but we only had 1.5 months. It was the best we could do but it actually worked wonders.
I never considered the tote bag itself…brilliant !
Just a bag - I understand why shorts and skeptical longs want to dismiss the revelation that a ‘coming soon’ campaign was initiated at SNO because it was just a tote bag. Let me introduce a concept to everyone here who is not a marketer, it is called a marketing channel. Advertisement is released through marketing channels.
Television is obviously a channel
Social media is a channel
A sales force is a channel
Radio is a channel
Newspaper is a channel
Banner ads on conference webpages are a channel
Utilitarian tools used at conferences like key cards, badge laniards, and tote bags ARE A CHANNEL.
A cheap and useful channel that speaks directly to your target audience where as television as an example is incredibly expensive and does not distinguish audience well at all, but still it is a useful channel because that one speaks directly to consumers.
You utilize the channels that will get you the best bang for your buck. Get it, got it, good.
Multiple choice question, which possibility makes the most sense:
A - FDA allows you to market your product before approval at any time as long as you call it a platform technology or use a temporary Brand Name.
B - Avoiding premarket promotion penalties is as easy as dropping the L off the end of your trademarked Branded product name
C - Advertisement only counts if it is on something that I personally deem valuable
D - FDA only allows you to premarket promote using very specific guidelines and only within 6 months of certain approval and does not care what channel you utilize
Now let me ask this question, is it more logical to believe the opinion of the few Biopharmaceutical industry and/or legal members on this board when it comes to interpretation of FDA regulations on ‘coming soon’ campaigns, or a bunch of shorts and beaten down longs who do not have any relevant experience?
The choice is yours to make. I can only help you so much.
BTW as I type this, I am looking at a few banner ads on the screen… is that a worthy channel in your mind or should we dismiss that one too?
Announcing PDUFA dates
The FDA doesn't publish an official list containing all of the outstanding PDUFA dates for drugs under review. However, many drugmakers announce when they receive a PDUFA date from the agency for one of their drugs. Such announcements can be major catalysts, especially for small pharmaceutical or biotech stocks. Some websites maintain calendars that track PDUFA dates for all pending FDA approval decisions.
https://www.fool.com/investing/stock-market/market-sectors/healthcare/pharmaceutical-stocks/pdufa-date/
What is one reason FDA may not publish a date? Manufacturer/Marketing entity request
The element of surprise can be useful outside and inside this context right here on this board
Let them continue to FUD and suppress stock price now, who will gain from that action?
Last post of the day…I am thankful for the members of this board and the support they have given me throughout this journey. As an example, I am thankful that Lykiri posted the statement from former head of US Commercial Operations at Merck. Multiple sources increases credibility which increases confidence.
If you are a true long, does shorting help or hurt your value at this point in the game?
You continue to make me laugh…
It has no relevance when it showed up first, it is where and how that matters. Crossing into a new space also crosses a new line. I wish loopholes were that easy. I would exploit the crap out of that if I could, but I can’t, so I don’t. The technology is the drug in this case and it is branded. Doesn’t matter if it is the brand name that FDA approves for use. Again, if I could use that loophole, I would exploit the crap out of that one too.
“You didn’t have to make it like you did, but you did, so I did. And I THANK YOU”
Sometimes intent is hard to demonstrate, sometimes it is quite easy…so I did.
This comment is actually comical, thanks for the laugh.
Silly Rabbit, Trix are for Kids
“You didn’t have to shake it like you did, but you did, so I did. And I THANK YOU”
It could be as thin as a post card stuffed in the bag. This regulation has very sharp teeth and minutia matters, hence no booth
Just so you know…I checked with friends and not just my opinion on this
Not the same ballpark at all. There are regulations that exist and are not enforced and there are regulations that are enforced.
If you do a coming soon campaign without FDA head nod, you may never be approved…ever. The drug may get approved after someone else buys it and submits, but you will never see the light of day. At least that is what I have been told is how they will treat you if you break that regulation.
My opinion of CRL remains the same, they have plenty of capacity to address US needs and more. The question was whether they still had an agreement and the tote bag must answer that as well.
I take back every critical negative thing I have said about management…pulling off a proper coming soon campaign.
They actually do know what the hell they are doing, many companies are scared to step foot in the coming soon arena. This separates the kids table from the adult table.
You are cordially invited to join me on the DTIL message board. I see patterns, that is my gift.
They avoided coming soon because you can only say coming soon or immune therapy, not both
No problem…just doing what all longs here do for each other. it is back in my head.
Seems to me like Big Trouble in Little China to do so again…
But only if you are not actually going to be approved. Then, no harm no foul.
Hoffman, Look at the photo again. Do you see that little circle with an R inside next to the word DCVAX?
BTW it would be hard to say with a straight face to anyone that you are in a quiet period still if you started a coming soon campaign which if that bag is real…you did!
Not a stretch at all…the law.
Ask yourself this question…how would Merck react to banners all over ASCO that said this (fictitious example)?
Precision Biotherapeutics
ALLLOCEL (R)
A Car-T Therapy
That is called a coming soon campaign and can only be done when approval is a certainty
They have a marketing piece at a congress with a trademarked product name and general mechanism. That is called a ‘coming soon’ campaign.
You can have name and general mechanism, you can have the words ‘coming soon’ and name only or you can have I believe company name only and disease state, possibly the words coming soon there as well. No one does the last option…first or second are the two seen. Generally, you only do the second if it is truly ‘soon’ like within weeks. If you kick it off earlier, you do the other.
From first draft label to approval is generally about 3 months.
IMO CassieW is spot on here… you are now left with only two options 1) pending FDA approval, or 2) fraud.
I always said FDA would come first if they are not doing Orbis…it seems I was right.
BTW if the booth design said a disease state anywhere on it, that is why there is no booth this year. You cannot do both. FDA does come down hard on coming soon violations.
You are only allowed to run a coming soon campaign within 6 months of approval and you have to have indication that you are on path to be approved from FDA…those are the rules as far as I have been told. I never looked into regulations myself, only believe what the attorneys have told me.
Usually they are shorter than six months because in my experience the attorneys won’t let you go forward without certainty which means draft label is already in play. You are never guaranteed that you will be approved, but once you get to draft label negotiations you know where you are headed, you just can’t say it publicly.
But you can run a ‘coming soon’ campaign. It has name and general mechanism. Bingo
It seems that they delivered at SNO after all.
So the bag is real?
If so, I agree with you that it is absolutely a ‘coming soon’ campaign. Focus on the word “immune” on that bag alongside a trademarked name of a product. I haven’t read everything here today so I don’t know what people are saying about this. If you have started a coming soon campaign it means that you are coming to market soon. You can’t start a campaign like that more than six months before approval and you have to have indication from FDA that you are on path to be approved soon, i.e., you are already negotiating the label.
If this bag is real, do people understand what this means?
It means we already won.
Just gitta share one more thought for the day…
Biosect, Perhaps you were actually replying to another post. Nothing in my last comment here has anything to do with security law.
I do have a series of questions for you though that I would perhaps some day like to ask you, but I will not open a paid account here because…. I cannot think of another way either and I will not reveal these questions publicly.
Anyways there are many regulations and laws and they all actually do intertwine to form string and rope. They can be knotted too, that is what excellent attorneys do. Justice too has many different twists and turns and one thing that is quite interesting about the American Justice system is that it is a jury of peers for many crimes and it only takes one juror. That too is something excellent attorneys can tie up and leverage. That is a sidebar.
I have learned and I believe mastered a technique called Motivational Interviewing, it is very interesting and fun. If we ever do connect on this, you will understand one way it can be leveraged.
BTW readers - I have not been reading this board and do not believe that tote bag was ever validated and congresses are not make believe places. The psychology there too is interesting. If it were however, it would be a coming soon campaign. If you don’t believe me, do the research and look closely and ask yourself questions about the words that you read. It would be a coming soon campaign IMVHO.
Biosect, I know that you disagree. I know that my character is haphazard with twists and turns and sometimes makes little sense or has very sharp corners that get removed, sometimes straight and get removed…it come with the territory and I apologize to all.
The reason that I put that stuff out there recently is that deep down, I knew this very moment would come and if I am honest with myself, I knew it for a long time now.
I still firmly believe what all of those lego pieces added up to.
They advertised (I know you don’t agree) that DCVax is safe and effective to treat (and sometimes cure) GBM. Believe it or not, I think that is OK and likely has no repercussions. They also DID have a deadline which just passed (I know that you don’t agree), but that is OK too and likely has no repercussions.
I believe this because they understand the twists and turns and alternate routes that have not been revealed too.
They only risk repercussions really if that statement is not true. If it is right and DCVax is Safe and Effective for the treatment of GBM with some certain cure rate but they can’t say cure they have to call it something else, then in most all cases, no harm no foul. They generally don’t go after premarket promotions from small companies that end up being factually correct. I believe that is because they are understanding of the barriers to entry and are sympathetic.
I don’t know why they are delayed and it is quite frustrating, but I believe that you do.
Time is money but the pie is so big, I don’t sweat the small stuff (did I get a harrumph out of that guy?). Time is also life and that is critical to minimize loss of whomever you are and whatever you do. I trust LL implicitly and if she can wait, I can wait. I may get more cranky sometimes and still question WTF is going on, but I can wait.
Do you believe that all of those warrants purchased since September 2020 either covered a short position or hit the market and cashed out? How firm is your belief?
Alpha’s video is not looking so funny to me anymore.
So you were right and there were additional LBAs, but unfortunately the only vaccine data presented is coming from Japan. WTF?
That tote bag has to be photoshop garbage and the verifier in question.
A Derek Johnson does pop up as being a Neuroradiologist in Minnesota. How do you know this is a legit assiciation?
This has to be the answer. There are way too many people at that meeting who know what is going on that you could not possibly keep one of them from saying anything they shouldn’t to someone else. Not possible. I am awaiting verification.
If that piece gets verified, I am calling it a Coming Soon campaign or Someone is a GINORMOUS MEGAPIXEL RISK taker. Perhaps Biosect, can provide a third explanation?
Biosect, I would love to hear your thoughts on this baby….taking a step beyond exhibiting and sponsoring the tote bag with the name of the product and tag line. Either that is a ‘coming soon’ campaign or I don’t know what I am seeing…you don’t have to say coming soon. What is your take on this juicy tid bit?
That is supposedly a physician from Mayo clinic holding up that bag.