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What's the UK local time now?
Oh, I am sorry. I got it wrong. You are from Georgia, are you not?
Congrats!
Pediatric trials should be definite given that the dendritic cell technology from the company were used for trials on pediatric brain tumor.
The following trial should not be neglected in which the combination of dendritic cell vaccine with CYT107 was adopted.
Therapy to Treat Ewing's Sarcoma, Rhabdomyosarcoma or Neuroblastoma
https://clinicaltrials.gov/study/NCT00923351
Director- Cell Therapy Operations, Oncology R&D, Early Clinical
Is there anything wrong in my estimate?
https://investorshub.advfn.com/boards/replies.aspx?msg=174334924
Doc logic,
The following article has the following description:
I don't know about Moderna.
Why does NWBO need sales team? Did 200 GBM patients between June and August last year come to receive the DCVax-L treatment because of the work of sales team? I don't think so.
It carries special significance for such a prestigious institution to post about the Nature paper.
So now a hypocrite who has been claiming all proceeds will go to charity is playing stupid. How many minions on this board are working for you? BTW, did you let your lawyer contact Cofer Black too?
Ask your boss, whosleftholdindabag if he still plans to write a book. I guess not.
You can keep playing as his minion.
The age doesn't matter. What matters is that they know the filed much better than other people. I know some people older than 80 have much sharper mind than mine. Have you ever watched the ASM of Berkshire Hathaway? Did you see wear and tear of all those printed documents surrounding Les? It means Les read all of them and he may read several times.
If you are using the Wall Street doctrine to measure the company, sorry to say you are wrong.
Truthfan,
Sharpe eyes!
If I can nail that hypocrite Nemesis, you don't think I can tell if you are TJ or not.
You want something definite. I give you an optimistic estimate and a conservative one so you can get ready. Roche sc Tecentriq has PDUFA set on September 15. Something must happen before September 15. This is the conservative estimate. Merck is going to have Oncology Investor Event on June 3. Something should happen before June 3. This is the optimistic one.
FYI, I do have Boma available, free of charge. I even picked up the word from PM.
Couldn't agree with you more. I have my champagne ready.
You most likely read this news before since it was old one. I just read it yesterday when I was trying to search something about CYT107. We are going to embrace an empire built up by LP.
New way to fight sepsis: Rev up patients' immune systems
Clinical trial demonstrates significant, lasting increase in key immune cells
https://eurekalert.org/news-releases/597984
Interleukin-7 restores lymphocytes in septic shock: the IRIS-7 randomized clinical trial
https://insight.jci.org/articles/view/98960
TJ,
You sound really desperate. You should be. Checkmate is coming! This time is for real.
Even more interesting part is that Kelly Ganjei has been the board member of INmune Bio Inc since 2016. The other director of Novamune is Mark Lowdell who happens to be the CSO/CMO of INmune Bio Inc.
There are several possibilities. What about Novamune and Inmune bio?
But one thing is for sure. All the possibilities are exciting!!!
https://www.inmunebio.com/index.php/about-us
george,
Poor IC,
How could you not be dumb if you reached Fraudstein for advice? You can ask him about my post. He would understand how my post is related to NWBO.
Gary,
My post is about the way Merck is handling its p3 trial results on SC keytruda is quite different from what BMS and Roche were doing on their SC checking point inhibitors. Since Merck and NWBO are highly correlated with each other, I was wondering if there is any special reason that Merck chose to submit the study results without any PR, poster, presentation.
Here is something funny. Merck put May 20, 2024 at the results updated date on last Friday. Today they corrected the date.
Absolutely right! Thanks
Several binary events have happened in the past a couple of years.
Gary,
If it is not today, we can expect something before ASCO.
Here is something interesting and I am not sure if it has special meaning.
Roche had PR on its p3 trial of subcutaneous Tecentriq on August 02, 2022 and later some presentations and publications
https://www.roche.com/media/releases/med-cor-2022-08-02
https://www.sciencedirect.com/science/article/pii/S0923753423006944
https://medically.gene.com/content/dam/pdmahub/restricted/oncology/hopa-2023/HOPA-2023-poster-burotto-IMscin001-part-2-randomized-phase-iii-pharmacokinetics.pdf
Then in January 2023 Roche filed for FDA approval as mentioned in 10Q from Halozyme .
I like something deep and insightful. Mav. listed all these BPs and I dug deep to see if the list makes sense. It does.
No need to worry.
I once did investigation on the combination of poly-iclc with keytruda. No breakthrough was made out of the trials related to this combination.
https://clinicaltrials.gov/search?term=poly%20iclc%20%2B%20Pembrolizumab
The same happened to the combination of plx3397 with keytruda
https://clinicaltrials.gov/search?term=plx3397%20%2B%20Pembrolizumab
What about poly-iclc? Which company is going to manufacture poly-iclc? Do you know how many steps it takes to manufacture poly-iclc? Why did Merck hire people with expertise related to each of the steps in manufacturing poly-iclc?
Make sure double check with me when Curia Global is also the company which will manufacture poly-iclc.
bio,
I bookmarked this post. Let's see what will happen soon.
BTW, when you write post, don't make it effusively verbose in a way to show you have deep insight. As illustration, no one has patience to read your long post on CSF1R-I. You just need to say one line: CSF1R-I can deplete tumor associated macrophages that suppress t-cells loaded with tumor-associated antigens. That's all we need to know. Next time make it concise and simple. This way can save your time and readers' time too.
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