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Thanks for the reply, Doc
It is really weird that Merck has not released any PR on the p3 trial and in the meantime clinicaltrials.gov was updated with the study results on p3 trial.
Neither BMS nor Roche did it this way.
https://news.bms.com/news/details/2024/Bristol-Myers-Squibb-Data-at-ASCO-GU-2024-Showcase-Transformative-Research-in-the-Treatment-of-Genitourinary-Cancers/default.aspx
https://www.globenewswire.com/news-release/2022/08/02/2489970/0/en/Roche-s-subcutaneous-formulation-of-Tecentriq-demonstrates-positive-Phase-III-results.html
Well, think whatever you want. Our mindsets are completely different from each other.
After the data lock of p3 trial or submission of the JAMA paper, is it hard for CEO of any BP to sign NDA and take a look in details what LP has been accumulating over the past many years? I guess it is not hard at all.
Don't forget I firmly believe that DCVax-L will be the cornerstone of the Moonshot program.
Horse,
Thank you for your kind words which I took as great encouragement.
Last time I heard you would have your champagne ready. Keep the champagne cold. I suspect we may have something great in the next two or three weeks.
IMO, it has everything to do with NWBO. The only question is whether they are going to release all the partnership at one time or one by one gradually.
I checked all the targets currently adopted in all the ADCs and located them in the data from Bulk RNA-seq analysis Dr. Liau uploaded. Take a look at the variations of those targets before and after receiving DCVax-L and its combinations. I strongly believe this is the reason all the BPs have ADC and t-cell engager in their programs.
P.S. Forget about the last two columns on the upper right corner since I believe the data column should be switched.
EX,
Here is the PR from BMS on subcutaneous Opdivo. The PDUFA is Feb. 28, 2025.
https://news.bms.com/news/corporate-financial/2024/U.S.-Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibbs-Application-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx
bio,
IMO, the massive hiring and construction of massive manufacturing facilities from BPs has little to do with mRNA.
Take a look the number of trials on cancers run by Moderna. There is only nine. Has Moderna found all the neopeptides that can trigger anti-tumor immune response? I guess not. Otherwise, Moderna would not come to a company which has the patent on neopeptides. Have we seen that GRTS who claimed their neopeptide based technology is superior to Moderna's had rather mediocre results from their GBM trial?
Everyone is entitled to his/her own opinions. The uttermost thing is that we have conviction in the science, LP and the company, and we all are ready to embrace the huge success of the company.
https://trials.modernatx.com/search-results/?SearchTerm=cancer&Latitude=&Longitude=&LocationName=&conditions=&Status=&phases=&AgeRanges=&gender=&GenderDescriptions=&StudyTypes=&AttachmentTypes=&MileRadius=100&PageIndex=0&hasResults=&isHighValue=&SortField=&SortOrder=
marzan,
Thank you for the link.
Now it seems certain that BO received DCVax-L + Poly-ICLC. We can call it enhanced DCVax-L. Seems to me NWBO should have at least five hundreds GBM patients receiving such type of combination treatment by the time the approval package was filed.
Doc,
One more question. Since the results are lackluster, should Merck have the PR on the trial after the close of the market today so that the investors have the weekend to digest the news? I wonder if there could be some great news we can expect from Merck, for instance, the paper on the combo trial.
Thanks, Doc logic
That's not a good news for Merck. This could make slim Merck's hope of extending its keytruda patent.
No wonder Merck has been slow in releasing the top-line-data on this trial. Roche filed the approval for its SC Tecetriq within nine months of finishing enrollment. Both BMS and Roche adopted the same technology to speed up the process of the drug going into blood vessel. Merck used its own technology.
Did Merck just put the study results on its subcutaneous keytruda on line? Has anyone seen any PR on this trial from Merck?
Seems really weird. The date was even next Monday.
https://classic.clinicaltrials.gov/ct2/show/results/NCT04956692?term=subcutaneous&lead=Merck&draw=2&rank=6
Thank you for your reply.
My understanding is:
1. After the 2014 or 2015, unless specifically mentioned, by default, DCVax-L always means DCVax-L + poly-iclc.
2. The approval is about DCVax-L + poly-iclc with huge amount of data from the compassionate use program.
3. The approval is not coming from MHRA only. The approval could come from multiple RAs at the same time. We didn't know too much about RevImmune before the Danish Dude took a deep dive, did we? I don't think we knew there was a trial using DCVax-L in combination with CYT107 either.
4. The collaboration colorectal cancer trial is real. Anyone who has doubt can go through all the trials with Markus Mohler as principal investigator to see if there is a trial from Merck. If there are no trials sponsored by Merck, how could he consistently funded by Merck? Here I listed some of the trials in which he was the PI.
Pfizer (2006)
Efficacy and Safety of Sunitinib in Metastatic Gastric Cancer
https://classic.clinicaltrials.gov/ct2/show/NCT00411151
Bristol-Myers Squibb (2016)
Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/?Esophagus Junction Cancer (CheckMate649)
https://clinicaltrials.gov/study/NCT02872116
An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer (CheckMate 577)
https://clinicaltrials.gov/study/NCT02743494
https://www.nejm.org/doi/full/10.1056/NEJMoa2032125
https://ascopost.com/issues/march-25-2021-supplement-gastrointestinal-oncology-almanac/nivolumab-plus-chemotherapy-new-standard-of-care-in-advanced-gastric-cancer/
EMD Serono Research & Development Institute, Inc. (2015)
Avelumab in First-Line Maintenance Gastric Cancer (JAVELIN Gastric 100)
https://clinicaltrials.gov/study/NCT02625610
https://ascopubs.org/doi/pdf/10.1200/JCO.20.00892
Inquiring,
Here is something good for you. I am sure your boss, Whosleftholdindabag, did not tell you he is a rich guy. Did he tell you at one time he owned 6m NWBO? Take this opportunity, do the right thing, and get rich. Being a minion is not something you are proud of for the rest of your life.
Does your boss have you doing illegal activities, like "marking the close" to manipulate the daily stock price of a specific company's stock price?
If yes, consider participating in the SEC whistleblower reward program.
- You can earn 10% to 30% of the monetary sanctions collected in successful enforcement actions if there is a minimum collection of $1M.
- The information must be original, of high quality, and must lead to a successful action.
- You may submit anonymously. To be eligible for an award you must have an attorney represent you in connection with your submission.
- A number of whistleblower protections can be available to you.
(Call me directly if that target company is NWBO.)
https://www.sec.gov/whistleblower
Great info.
Gary,
For other types of cancer, the number of patients through compassionate use program is only in tens. The number is not enough for filling for approval. My conjecture is the application should be at minimum DCVax-L combined with Poly-ICLC with possible guidance from RA about including keytruda. IMO, the approval will be based on the RWE from compassionate use patients.
Gary,
When was the contract on RWE between NICE and flatiron started? Was it before the commercial manufacturing license at Sawston approved?
I assume you do agree that at least two to five hundred patients received the DCVax-L related treatment before the submission of the application package.
Keep in mind NWBO said the package was filed. No place it was said specifically what type of approval they were filing. Would UK want to be the first one to approval a cell therapy based on RWE if such a chance was given? Absolutely!
https://resources.flatiron.com/press/press-release/nice-partnership-2020
beartrap,
How is it possible that they would file the approval for DCVax-L alone combined with SOC? Have we heard Les mentioned that last year in three months 200 patients received the treatments? Have we heard from any gofunding case in which the patient talked about receiving chemo while receiving DCVax-L since 2016?
Did you see three cases on t-cell expansion? See the numbers were measured at 4th month and 8th month. These three patients are from the p3 trial which means those numbers were obtained at least before 2015. Would the company measure all these numbers for patients in the compassionate use program? Absolutely.
I know every one wants to be conservative on their estimate. Let's try to be conservative by using the combo trial as an illustration.
Would you agree the outcome measures adopted in the combo trial are radical, disruptive, and revolutionary? They gotta be since we cannot find such measures in any other trials on immunotherapy. I once wrote a post claiming that the combo trial was implied in then NCI director Monica Bertagnolli's report. The trial also has Merck as one of the collaborators. For a trial of such magnitude, none of participants can afford to adopt the measures that the trial results in the end could not meet. They have to conservative. Should we ask ourselves the question: what could give the trial designers the confidence so that they were bold enough to adopt such measures? The answer is simple. They have been using measures like these somewhere else. They can only have the data on these type measures from the compassionate use program. That's the only source. Now they would like to see if such measures would produce better results by including keytruda. Is DCVax-L in combination with poly-iclc the placebo?
Every investor likes something deterministic. But I suspect retailers can earn money once something becomes deterministic. I hope in the end if I am right, someone on this board could buy me a beer. LoL.
As I mentioned to beartrap, it is possible that Merck could use the combo trial on colorectal cancer to file for application too.
hyperopia,
Thanks for your post. I didn't mention here. RevImmune as a company which is also listed as the inventor of the combo patent and is solely owned by LP may also run some other trials with other BPs.
No problem you think my speculations are far-fetched. My only question: are you going to buy me beer if some of my speculations are right? LoL.
IC,
You see what is your problem. You solely depend on Fraustein for investment advice. That is why you learned nothing over the past many years. Now you are lecturing your BS understanding about this and that which you don't believe yourself.
When you are broke sooner or later this year, you would never forget the lessons I taught you.
IC,
Do you recall I was the first one on this board who correlated the following figure with the p3 trial? I believe I was also the first one who said something exciting was going to happen between one and two months based on the information in the post by the President of Oncovir. One month after his post, the article on prostate cancer showed up. Exactly two months after his post, the Nature article showed up. I have been repeatedly mentioning about the secrete colorectal trial which will be published definitely before the PDUFA of Roche's SC Tecentriq.
If you give me credit on the above, you should listen to me one more time: you are not on the winning side.
Gary,
I am confident your dream will become true this year.
I have no idea why they want to keep it secret. Merck don't want to bring any potential competitors.
beartrap,
I think they intend to keep secret the whole trial. That's why no definitive information can be found.
horse,
No one can bankrupt the company now. Recall Baker Brothers made over $8 billion by selling Seagen to Pfizer. What did they do with $8 billion? Instead of reinvesting the money, they gave back to the investors. Seems to me the two brothers cannot find a good investment opportunity and big players must have deals struck with LP already. Note Julie Baker had his Ph.D. on immunology from Standford.
I have no doubt it happened. You can see around the same time LP signed two collaboration deal with two main players on checking point inhibitors. Colorectal trial with Merck and rGBM, a much tougher target with BMS. Merck cannot terminate the colorectal trial and then later became one of the collaborators of the combo trial with the termination of the collaboration trial between BMS and NWBO.
I suspect the reason they chose trial site at EU is that before January 2023, clinical trial was not required to be registered on public website.
Is it after mid-night in UK?
I am sorry. I forgot you are living in Georgia now.
Discontinued? That's Ex's lame wish. According to Ex, the scenario should be Merck discontinued colorectal cancer trial and then sabotaged BMS' rGBM collaboration trial with NWBO. It makes sense to Ex since he doesn't have commonsense. It doesn't make sense to me at all.
Have you read my post on the PI in charge of the colorectal trial?
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174356517
beartrap,
I just have a wild question.
Assume the following collaboration trial between NWBO and Merck was really accomplished and the results were fabulous, can Merck along with NWBO use the results to file for FDA approval without triggering any SEC filing before notifying investors the final news?
https://pipelinereview.com/NW-Bio-Announces-Phase-II-Clinical-Trial-Program-Combining-DCVax-L-and-Pembrolizumab-Keytruda-for-Colorectal-Cancer/
https://www.unimedizin-mainz.de/mct/startseite.html?tx_news_pi1%5Bnews%5D=4665&tx_news_pi1%5Bcontroller%5D=News&tx_news_pi1%5Baction%5D=detail&cHash=325943f1432d568f8f26286d154c3952
IC,
You seem stressful. You are not a shareholder. How could you be so stressful? Read all my posts directed to you before. Have I ever uttered any vulgar language? Most of the time I always presented you with facts to convince you: don't try something that definitely dooms. It is pathetic you are brainwashed by Fraudstein and never listen to me.
Well, take care of your stress first.
https://www.mdpi.com/2072-6694/13/22/5816
Last week news on Oncovir.
Cancer Therapy: Introducing Oncovir’s Hiltonol, a Warrior Against an Invisible Enemy https://t.co/hXdO9eay70 #HealthandWellness #cancer #Medical pic.twitter.com/Fk3B9qtWwV
— Grit Daily News (@GritDaily) May 7, 2024
Here is something I get for you. But I am not sure if you can grasp the whole meaning of it.
BPs are hiring people with background on biomarkers. What type of technology are they going to use to find the biomarkers that can be used for cancer treatment? I suspect the biomarkers they are seeking are the genes overexpressed on tumor cells rather than on normal cells.
Amgen
Scientist, Oncology Biomarker Discovery
Did you get someone else's medical record without consent? Or did you photoshop the medical records? Either way the two neurosurgeons are listed in the records. Did you impersonate as a former government employees and a former solider? You said you submitted your narratives to NICE and MHRA. What if Laura cannot find the narratives? The company can sue you for libel. Ask your boss to answer those questions.
IC,
Your old sarcasm doesn't work. Give Voodoo a try.
I never pay any attention to what you post since I am allergic to BS always.
Now I hope you keep hanging around this board. I want to see how' your desperation evolves as each day goes by.
Why did you not post your guide, Fraudstein's new post on this board? Did he try to throw you under the bus?
I am sorry. You mean I was dumb and didn't realize you are the real victim.
You are no difference than most on this board. Really? I cannot believe you have the audacity to flatter yourself this way.
Thank you for sharing your critical thinking.
I don't know the answer to my questions. As a matter of fact, I have more questions.
Was the analysis as mentioned in the unpublished paper carried out before the re-ignition of the Moonshot program?
https://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE249282
https://www.whitehouse.gov/briefing-room/statements-releases/2022/02/02/fact-sheet-president-biden-reignites-cancer-moonshot-to-end-cancer-as-we-know-it/
I have no affirmative answer. Based on the words in 10Q from August 2020, it could be
Gary,
It is a new patent with controllable chain length of poly-iclc. Here is the part taken from the patent.