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thermo, is it possible that Dr. Roger Stupp is/was involved in the peer review process?
flipper44,
I can confirm that sentiment is absolutely correct. No SAP until 2020.
I agree with your last sentence.
Thanks Hbpainter. Excellent paper.
I got a reply:
Pablo has had his brain tumor treated with the laser. (October 2018)
So sorry to hear this. Thanks for sharing muee88.
From his blog:
Feb.22, 2021
BRAINSTRUST
02/10/2019
Immunotherapy DCVax® – information for patients and carers
Elvisdk,
Thanks for sharing. I hope Klaudia is doing well. The latest news sounds encouraging! I wish Klaudia, you and the kids all the best!
The Sawston location.
For those interested in Charles River Laboratories:
UPCOMING WEBINAR
Cell and gene therapy matures: Streamlining and smoothing the path to commercialization
Tuesday, January 11th 2022 8:00 PST; 11:00 EST; 16:00 GMT; 17:00 CET
https://www.insights.bio/cell-and-gene-therapy-insights/webinars/275/Cell-and-gene-therapy-matures-Streamlining-and-smoothing-the-path-to-commercialization
Agreed. Ms.Linda Powers taught for more than six years at the National Institutes of Health, on medical product development and commercialization.
exwannabe,
I asked Professor Axel Glasmacher about the issue (a change in endpoints – “suitable for approval” by the EMA, PEI, and MHRA)
He was a moderator at CDDF Multi-Stakeholder Workshop / April 2021 “Endpoints in Cancer Drug Development”
Reply from Professor Axel Glasmacher:
Thanks BlackMountain!
Reefrad,
Thanks for sharing!
flipper44,
Thanks for sharing! I was not aware of MHRA's new guidance. That's great news!
exwannabe,
Flipper44 is right. The professor stated that without the increased number of patients with hypermethylated tumors in checkmate 548, the methylated mgmt would have been 21-26 months.
Thanks flipper44. I completely agree.
flipper44,
About Phase 3 CheckMate -548 Trial Evaluating Patients with Newly Diagnosed MGMT-Methylated Glioblastoma Multiforme (NCT02667587)
I asked Professor Filip De Vos (co-author) if he had an explanation for the high MOS in the 2 groups. (placebo and nivolumab arm)
Here is a quote(translated) from the correspondence:
“The high MOS in both groups is mainly due to MGMT hypermethylation status of the tumor, which makes it very sensitive to chemotherapy, resulting in prolonged progression-free and overall survival.”
exwannabe,
Last patient in the UCLA-Merck combo trial was enrolled around May 21, 2021.
Happy New Year!
Sentiment,
Reply from Michael Lim:
Captain, thanks for sharing.
Happy New Year!
Thanks for sharing Nick119.
Didn’t know that 2 of his sons had brain tumors as well. How sad.
Happy New Year!
The Danish Dude,
Thanks for doing these articles! Happy New Year!
sentiment,
In my reply I pointed him to the use of external control patients in the DCVax-L study.
I asked him if he would like to share his opinion about the use of EC.
NOTE: My reply was sent before you and Newman post about it.
I asked Professor Michael Lim for clarity.
Here is the reply:
HiXXXXX,
Sorry what I meant to say was
An exciting new category of immunotherapy candidates for GBM worth noting is dendritic cell vaccines: preliminary data from the Phase 3 trial for DCVax®-L may show increased survival for patients with newly diagnosed GBM [2]. However, this study is still ongoing, and final results are pending.
I think that if the phase 3 data shows significance, there won’t be a need for another trial, however I heard that patients were allowed to cross over and that may be an issue.
Thank you,
Mike
--
Michael Lim M.D.
Professor and Chair, Department of Neurosurgery
Professor, by courtesy, of Medicine (Oncology), of Neurology, of Otolaryngology, and of Radiation Oncology
Stanford University School of Medicine
Center for Academic Medicine
453 Quarry Road
Neurosurgery 5327
Palo Alto, CA 94304
Phone (650) 721-6736
Thank you StonkMaster.
About co-author Michael Lim:
Probably a coincidence but Dr. Bosch's talk on 1/20/2022 is followed by Dr. Michael Lim's presentation: Mechanisms of Immunosuppression and is divided into two topics:
1. Understand current landscapes of immunotherapy for brain tumors.
2. Understand the obstacles for developing effective immunotherapies for
brain tumors.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=166956036
Yep, to my understanding, you are correct.
immuno
Review
Applying Synthetic Biology with Rational Design to Nature’s Greatest Challenges: Bioengineering Immunotherapeutics for the Treatment of Glioblastoma.
Leila A. Mashouf 1,2,* , Janet Y. Wu 1 , Pavan Shah 3 , Nivedha Kannapadi 3 and Michael Lim 1
Received: 1 December 2021
Accepted: 24 December 2021
Published: 29 December 2021
Thanks Nick119.
I e-mailed the FDA on Dec.10, 2021.
See email attached from FDA replying to my inquiry:
Dec.10,
Very interesting new patent. Thanks for sharing and Merry Christmas to you flipper44!