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I don't think they'll PR both, just the approval. NWBO has always stated that they are going for an approval.
If NWBO filed before April 3, then the MHRA's CHM meeting, which is scheduled years in advance, is on June 29 or 30. The BNOS conference in Manchester, which NWBO is a platinum sponsor, is on July 3-5.
Anybody considered that the $3M received is a milestone payment for filing? Just saying...
These are some of the adjectives that Dr Mulholland used in his presentation
"Landmarked, exciting, meaningful, very very happy, extremely important statements, very very exciting, really important, very very favorable, really very intrigued, Really impressive, really very interesting, so impressive, really very impressive, practice changing results, overwhelmed by it"
TTF, if DCVax-L vaccine, which BTW was developed in UCLA labs, is not effective or waht kyou claim as a "scam", would UCLA PR this in 2018?
An international study led by UCLA researchers has found that a personalized vaccine may help people with glioblastoma, the deadliest form of brain cancer, live longer. The vaccine, known as DCVax-L, uses a person’s own white blood cells to help activate the immune system to fight cancer.
Nearly 30 percent of people in the ongoing trial have survived for at least three years after they enrolled in the study. Currently, the average life expectancy for people diagnosed with glioblastoma is 15 to 17 months, and less than 5 percent of people who receive standard treatment survive more than five years after they are diagnosed.
https://newsroom.ucla.edu/releases/personalized-vaccine-increase-long-term-survival-glioblastoma
Thank you Marzan for letting us, the AMRNians, know about this little known biotech company. It was your April 2017 post that got me interested to NWBO. I wonder what JL is feeling now?
Is that why we have the delay when Roger called LP and ask - Do you have any opening?
The last financing was done in August 21 for $5M. Notice that no financing nor dilution in September. Is it because NWBO has already unblinded? Follow the money....
From 2019 10Q "As resources permit, the Company is working on preparations for Phase II trials of DCVax-Direct"
From 2020 10Q "As resources permit, the Company is working on preparations for Phase II trials of DCVax-Direct including discussions with key institutions in regard to trial design and trial preparations. The Company has stopped the DCVax-Direct contract manufacturing preparation activities at present, while the trial design activities and preparations with the trial sites continue."
I'm surprised no one is talking about Direct.
"the Company is working on preparations for Phase II trials of DCVax-Direct including discussions with key institutions in regard to trial design and trial preparations."
Institutions like MRK and investment bankers for partnership?
My guess for TLD will be Monday, August 3 or 10. NWBO will present the full trial results and publication at ESMO Congress in Madrid, September 18-22. ESMO will notify them if they get accepted by the end of July, which is a Friday. Similar to AMRN, they'll release TLD on a Monday, either the 3rd or the 10th.
"Abstract outcome notifications are expected to be sent to first authors by end July 2020."
https://www.esmo.org/meetings/esmo-congress-2020/abstracts
I second that Smokey. Dave mentioned that they view Data Lock as a material event.
I'm doing the same thing Tilt, accumulating at this bargain basement price. It kind of reminded me of Jim Cramer's book during the 1987 black monday crash. He wanted to liquidate their positions while his wife, who was also a trader at that time, was so cool under pressure that she started buying!
I talked to DI this morning and he confirmed that Sue is indeed an employee.
POSITIVE CLINICAL RESULTS - Outlining the key aspects of the DCVax technology that contribute to the "positive clinical results"
I googled that phrase and came up with the following:
https://www.itnonline.com/content/theragnostics-reports-positive-clinical-trial-results-prostate-cancer-study
https://www.prnewswire.com/news-releases/ani-announces-positive-clinical-results-from-cortrophin-gel-cortisol-response-study-300930183.html
https://www.medicinenet.com/script/main/art.asp?articlekey=39070
https://www.centerwatch.com/clinical-trials/listings/condition/898/breast-cancer-her2-positive/
https://www.statnews.com/2019/10/21/seattle-genetics-to-seek-approval-for-new-breast-cancer-pill-after-positive-clinical-trial-results/
I'm a veteran myself (USAF - Aim High!) and would have liked that they released topline today, in honor of LP's dad, who was in the marines.
For all active duty, reservists and veterans, thank you all for your service!
What a better way to announce topline on Veterans day in honor of LP's dad who was a Master Sergeant in the marines.
This presentation is in December, 3 weeks after SNO. The embargo for late breaking abstract at SNO is effective from Sept 1 to Nov 22. Is NWBO scheduled for a conference between now and Nov 22? If they are, they will not present unblinded data at SNO. If they are not, expect topline to be announced after Sept 15. Just my opinion.
Agreed which is why on And on Aug 26, Cognate announced this:
Cognate BioServices Secures Growth Capital Investment from EW Healthcare to Continue to Expand Commercial Manufacturing Capacity and Services for the Cellular Therapies Industry
I agree flipper44. This is what I said on my post #231149:
My guess will be Monday 9/16/19. This is why - the last day of 2019 SNO's late breaking submittal is 9/1/19. From SNO's website "Authors will be notified within two weeks of the September 1st deadline if their abstract has been accepted for presentation". Similar to AMRN, NWBO will publish their result on the Neuro Oncology Journal and will present orally at the SNO conference (Nov 20-24) in Phoenix.
Sept 1 gives NWBO 3 months for the submittal of the SAP, reviewed/blessed by the FDA, data lock, final analysis for Topline.
LP's comment from the 2/2/19 ASM:
We were subjected to excruciating pressure to go to data-lock and finish the trial. Long before the data we reported last November. That data was presented in a plenary session at the Society for Neuro-Oncology, the biggest meeting of Neuro-Oncology subjects in the world. That's a big deal.
Mic drop....
Marzan, let's play the "Topline Date" guessing game similar to what we have at the AMRN board.
My guess will be Monday 9/16/19. This is why - the last day of 2019 SNO's late breaking submittal is 9/1/19. From SNO's website "Authors will be notified within two weeks of the September 1st deadline if their abstract has been accepted for presentation". Similar to AMRN, NWBO will publish their result on the Neuro Oncology Journal and will present orally at the SNO conference (Nov 20-24) in Phoenix.
Sept 1 gives NWBO 3 months for the submittal of the SAP, reviewed/blessed by the FDA, data lock, final analysis for Topline.
I emailed Jeopardy about Alan Butler's (National Geographic) stage 4 pancreatic cancer fight using DCVax Direct.