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I'm sorry, but the 2026 date keeps getting repeated. The way I read it keytruda patent expires 2028
LP allready said they were caught with their pants down that day. They did a horrible PR job. No one knew what was going on, they just saw SP drop like a rock and NWBO was left scrambling. There is no way to spin that day
AI--- can you submit for fda approval with a combo of drugs without each drug being approved prior?
Yes, in most cases, the FDA only requires one marketing application for a combination product, even if the constituent parts are not yet approved individually:
can you submit for mhra approval with a combo of drugs without each drug being approved prior
Yes, the UK's Medicines and Healthcare Regulatory Authority (MHRA) allows for a single application for a combined review of a Clinical Trial of Investigational Medicinal Product (CTIMP) and a medical device. This combined review process allows for a single application, review, and decision for both the CTIMP and the medical device.
The combined review process is available through the Integrated Research Application System (IRAS). The application is sent to both the MHRA and a research ethics committee (REC) at the same time. The regulatory and ethics reviews are done in parallel, and requests for further information are raised jointly.
the FDA requires additional studies for combination products in many cases, even if the individual drugs are already approved. This is because the FDA applies the combination rule, which states that each component of a combination drug must contribute to the claimed effect and the combination must be safe and effective for a significant patient population.
Here are some other things to know about combination products:
Marketing application
The FDA usually only requires one marketing application for combination products.
Regulatory status
The constituent parts of a combination product retain their regulatory status, such as drug or device.
CGMP requirements
The CGMP requirements that apply to each constituent part also apply to the combination product.
Marketing authorization
The combination product is typically marketed under the same type of authorization as the constituent part that provides the primary mode of action.
Scientific and technical issues
New scientific and technical issues may arise when combining drugs or devices, such as new manufacturing methodologies.
Novice question. I've been away a few days and thought about this. Once MHRA approval, they would need to submit for combo approval, is that correct? Anyone have an idea how long that would roughly take? Also, can they apply for combo approval with FDA before just submitting for dcvax approval?
seeing as its only half way through, sure it is. But I like oct better. jmo
Just curious, and its just a tv show, but they are talking specifically about dc vax, this opens up a whole can of worms doesnt it since its not an approved treatment? Look at the implications if the character dies or if he has side effects? Interesting
It might sound funny, but just a mention like that could create widespread interest. I hope nwbo can capitalize on it. If I were Les, I would appear on big biz show wearing a t-shirt from the tv show and mention it. Creating interest will spur buying which will create more interest. Anything is better than sub 30 cents
"The key patents for Merck's cancer immunotherapy drug Keytruda are scheduled to expire in 2028 in the United States. In Europe, the patents are set to expire in 2030.
When the patent expires, biosimilars, which are near copies of expensive biologic drugs, will be able to compete with Keytruda. This could lead to a decrease in sales, with some analysts predicting that sales will drop to $27.4 billion in 2029. To offset the loss of revenue, Merck is taking several steps, including:
Licensing deals
Merck is working on a licensing deal with Daiichi Sankyo for a cancer drug that could be worth up to $22 billion.
Building a pipeline
Merck is developing a pipeline of early-stage assets to strengthen its immunotherapy portfolio.
Acquiring Harpoon Therapeutics
In early 2024, Merck agreed to acquire US Harpoon Therapeutics for $680 million to advance its oncology portfolio. "
I dont follow, the lawsuit has nothing to do with MHRA decision. Why would the judge be waiting? Case deals with years of spoofing and manipulation of SP. It was filed before submittal to MHRA. Apples and oranges.
I thought election years were bad for the market due to unknown factors coming in.
My number is based on the new price is right. beat top or bottom bid for 1$. Just trying to add a little jocularity. I'm praying the highest number is correct. One week allready into September. Next 7 weeks we will know something significant, just my opinion. If not, I will keep my mouth shut until 2025. Enjoy the Fall!
2.99 billion
read before deleted. I wonder if ihub uses fudsters just to increase volume. Because some of these posts are beyond rational thought
and yet you feel the need to post on this stock daily. strange, very strange.
riiiight, approval of a new cancer treatment will cause the stock to go backwards. People dont want to live longer, they enjoy using chemo/poison. I hear they even love the side effects, weakness, losing hair, throwing up, etc. They want to pay higher prices. Please share with us some of the stuff you've been smoking because it must really be good if it causes this type of delusion. .
How dare you talk common sense. The delusional are telling everyone the are billions of shorts and we will see a gamestop type squeeze that will make each share worth 150$ to 200$. Hedge funds have no idea what they're doing and "shorties" will soon burn. give me a break.
and how do you get the sum of 150 to 200$? just pulling numbers out of thin air? We are at .30 , thirty cents, three oh, and you're talking wishful thinking it goes above 100$ Give me a break or show how this sum was reached. Rumor also had we would be approved by end of june. If this were true, why wouldnt nwbo offer 1 cent per share dividend to weed out naked shorts, or merge with a shell company?
The man doubts LP will give up control LOL! Such insight from an account created 5 months ago. Allready set on ignore since his posts have gone from amusing to delusional.
another day another POS trying to bankrupt a company looking to help those suffering from cancer. I bet you have no mirrors in your house.
Realitycheck/common sense #2. Its very reasonable SP goes to $3 upon MHRA approval. Thats a 900% gain! (math not my strong suit). Where else but vegas can you get 900% gains ? 900% gains with very little , if any, risk thanks to dc vax allready being used for compassionate care cases. Its the government, so not ruling out some unforeseen , but unlikely,like a rug pull. Approval leads to recognition, which leads to increased SP, which leads to more recognition...and so on.
There are no more "what ifs", only "whens".
Why 3$? Because it went almost to 2$ on TLD only. 3$ is a conservative estimate. This is without the lawsuit , squeeze, or factoring in B/O. Combo trials take time and merck/keytruda is running out of time (patent)
Applying to FDA shoots SP to $5 and approval 10$ and up. just my conservative unbiased opinion.
Common sense/reality check. No one knows when MHRA will approve, but it has been a while since submission and no rejection or red flags yet. Approval comes when it comes, no news is good news. SP was close to 2$ on TLD release. No reason it should be any less (probably much more) on MHRA approval. Buildup of manufacturing continues so they must believe approval or they wouldnt be wasting time, money, or resources. Remember, LL is on the board and I'm sure she wouldnt put up with any nonsense with her name and reputation associated with dcvax and nwbo.. Timeline for combo trial finish moved up, which means they must know something and since they are very close, looks like no red flags again. No one knows whats going on with lawsuit except those involved, but no news is good news since MTD not granted. SP continues to go down, but mngmt not panicking and they own many millions of shares more than all of us combined, so no reason to sweat SP yet. Combo trials seem to be cancelled left and right, but no negative news about DC-vax.No news sucks, but no bad news anywhere is a good thing. JMO
"Nothing wrong with chemo/rad. It is tried and true.", Then explain why so many patients refuse to go through it for another round because they say side effects are not worth it. Nothing wrong with injecting poison is ones body, what could possibly go wrong. A regular walk in the park. FUD is getting weaker by the day
"It is NYC, everybody is on vacation till after Labor Day".
stop it, next you'll be saying its too close to halloween or christmas, then the end of the year slowdown.
“NWBO put out the lawsuit to give more false hope to retail investors in my opinion”
-Legend431-
yes, they collected 5 years of data as a headfake. Then convinced a world class attorney to give up her time for free since payment is based on how much damages or settlement is for. FUD getting more non-sensical by the day
I check in today to see if any updates. Instead I see posts abour "nefarious forces", mooohahaha. MTD delayed because of school openings and vacations. Investors recognizing inspectors so natuarally they will buy multitudes of shares. And of course, "the whistleblower:. Thats enough for today, the real fun begins mid september. Im off to work in the yard and plant a new fig tree. Keep watching those "nefarious forces".
hold out for molson
Good news is patients living 4+ years. One scenario that would make sense is Merck is waiting on MHRA approval before bringing buyout to its shareholders. If they released fantastic results, competitor could buy majority shares in NWBO and wait out keytruda patent in a little over 3 years. It might also explain why creating so many new shares. They could be earmarked for Merck to prevent majority shares being bought by competing BP. Might also explain why Merck isnt shouting results of combo from the rooftops. JMO
Only 2 reasons why keytruda/dcvax combo trial results are being kept quiet. 1, its all BS, smoke and mirrors. 2. Waiting for UK approval for merck B/O. Keytruda patent expires in less than 4 years. dcvax combo patent would extend keytruda cash cow another 12 years at least. I would gladly take a 20 for one stock takeover because of the dividends and future earnings. Merck stock holders would approve if they see UK approval, knowing more to come, FDA, etc. I think mngmt are too old to go it alone for the many years it would take for all approvals to go through, all while being assaulted by BP. LP could probably negotiate a seat on merck board to oversee dcvax. Wishfull thinking, possibly, But oct is going to be very special one way or another. just my 2 cents
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According to a 2023 Reuters article, cash is often used in biotech mergers and acquisitions (M&A). For example, in March 2024, Vertex Pharmaceuticals announced an all-cash transaction to acquire Alpine Immune Sciences for $65 per share. In December 2023, BMS also used cash to acquire Karuna Therapeutics for $330 per share, which was a 53% premium to the share price at the time.
However, M&A can also be financed using a combination of cash, debt, and stock. For example, leveraged buyouts (LBOs) use a lot of borrowed money, with the company's assets often used as collateral for the loans. In this high-risk, high-reward strategy, the company performing the LBO may only provide 10% of the capital, with the rest coming from debt.
when has LP ever done anything the standard way?
You're forgetting dividends when owning merck and future SP on profits rising. Its the gift that keeps on giving. You get mercks legal, distribution, manufacturing, PR, sales force, and testing expertise.
oh for the luvva pete, here we go again with the apes, with a whistleblower, short squeeze, what Les meant, etc....volume says no one knows anything and is in a holding pattern. Upon approval, I would guess over $2 a share, at least thats where we were on anticipation of TLD release.. Later in the fall, between mid sept and late oct, I would guess they would announce future plans for dc vax, FDA submittal, partnerships, more trials, possible merger and uplisting. If they dont, then mngmt should just retire. Just my take, without any hail marys.
MTD is a wild card, but not putting any faith in the lawsuit. As for merck, why go exclusive since keytruda patent expires in 3 years? Then the combo would belong solely to nwbo. A lot of bio in the news lately. NWBO should go back to hiring a PR firm. The big biz show will not cut it. Have a nice day.
This story link should be on NWBO's home page. Some posters keep saying they should remain quiet, anything they say will be used against them. I say this story would give hope to a LOT of people. Study results are great, but nothing gets the word out like someone who has gone through the treatment. Living proof. Heck, put this man on their legal team.
only if it concerns their bonuses
zing....
Not hopeless, but pumping as well as fud has to be called out. I'm putting a buy order in for .25
May take a few weeks but nothing stopping the free fall.
no, not any day. Inspections....more like oct. It will happen, but not any day for a while longer.
Good news? In what way? Everyone knew they would schedule inspections at some time. they've known this since jan 2024. This just confirms everyones timeline is off. Instead of approval any day now, its now confirmed we are looking at months. What new investor is going to come in now knowing approval is months away?
I'll check back in mid august to see how bad the SP slid. What happened to "we will only comment on major news by" NWBO mngmt?
I sold big chunk of shares today on PR. Why? Because inspections havent occured which means kiss august goodbye for approval. They just gave mm's at least a month to walk SP down even more. I will buy back in the 20's. Was PR supposed to stop SP bleeding? Did they think this through?
I am now at 75k at average .56
I just bought some more today. not much, no spare money left and bills to pay coming up. Upon approval, which can be any day now , or weeks away, I expect SP to immediately go in the 2$ range. Thats 4x my investment. Where else but vegas can you get those odds? I'm not thrilled with the silent treatment, especially when SP is dropping 5% a day, but mngmt has millions of shares, warrants, and options. That is why I put my faith in them. Add to that treatment is allready in use in compassionate care cases. FDA, canada, germany, those are down the road. If I chose to stay in, each of which is easily 2x to 4x more on my investment.
I'm not completely understanding normal to low volume yet SP dropping so much. There has been no news. Also, not fully understanding why merck hasnt said anything about fantastic combo results, tick tock, keytruda patent 3 1/2 years until expiring.
I'm not putting any faith in lawsuit, but I believe new investors are not thrilled with a company in litigation, so MTD accepted or rejected will be a good thing. just my 2 cents. If SP continues to go lower, I will sell other stock to take advantage. The ham and egger excuses fudsters are coming up with is BS. They are causing SP to go down, then scream hey look, its going down. If news in fall, then mngmt better do something in august to counter the 5% daily loss. I cant say what, but then again I never ran a company nor got paid millions in salary .