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This is from the DEF 14A from December 1, 2016:
5% Security Holders
Cognate BioServices, Inc.(10)
4800 East Shelby Drive,
Suite 108, Memphis, TN
25,242,223
18.66 %
Woodford Investment Management LLP(11)
9400 Garsington Road
Oxford OX4 2NH, UK
25,915,937
20.95 %
Latest Proxy Statement:
5% Security Holders
?
?
?
Cognate BioServices, Inc. (7)
4600 East Shelby Drive
Suite 108, Memphis, TN
?
?102,024,505
?
24.4 %
?
?
Woodford Investment Management LLP (8)
9400 Garsington Road
Oxford OX4 2NH, UK
?
?24,815,028
?
?7.5 %
?
?CF Woodford Equity Income Fund (9)
40 Dukes Place
London EC3A 7NH, UK
?
?18,316,679
?
?5.6 %
WOODFORD: 43, 131, 707 shares ????
?
The last three years I learned a lot about a promising treatment (Dcvax-L) for glioblastoma
I admire Dr Linda Liau and I am grateful for her commitment to the treatment of this deadly disease
In sept. 2017 she said this:
Quote:
“I have a huge drive to prove that things that seem impossible can actually work,” said Liau. “When I first started working on brain tumor immunotherapy, everyone told me that you can’t mount an immune response in the brain. Now we know that’s not true.”
dd: 9/28/2017 http://medschool.ucla.edu/body.cfm?id=1158&action=detail&ref=1165
Today i found a quote from Gordon Freeman, PhD Professor of Medicine, HMS Researcher, Department of Medical Oncology, Dana-Farber.
He is in debate with an audience of students (Talks@12: Immunotherapy: An Answer to Cancer?). It's from 7 nov.2017.
At min.49.52 there is a question about immunotherapy and glioblastoma.
Flipper, some thoughts about Cognate jobs listings.
I don't know if they need the well-trained people for DCVAX production but i believe it is. But i think it's not so easy to find qualified people.
I found this video from the 2017 Longwood Seminaris "Immunotherapy: An Answer to Cancer?
In this video Dr. Jerome Ritz is talking about "The Cell Therapy Revolution" In min 56.44 he is talking about "Current challenges for CAR T therapeutics is Cell Manufacturing capacity" I believe he is the head of the Cell Manipulation Core Facility in Dana-Faber/Havard Cancer Center.That's a laboratory with 6 isolated clean rooms and they have about 50 people who are working full time. They are building a new facility on the 12 th floor of the Smith Building at the Dana-Farber Cancer institute to be completed in 2018. It's a building for 13 isolated clean rooms.He said you also need the well-trained people that can manufacture the cells. But you need to have quality control systems, you need to have quality assurance, you have to deal with all the regulatory issues .....so it's a complex environment.For me it looks familiar with the Cognate jobs listings.
So my point is that you can better look for qualified people before an approval because it is a challenge these days to find them and i think that is what going on at Cognate last year!
Exactly!
5,200,865 (x10) = 23 cent/share = approximately $11,961,990
2,941,176 (x10) = 17 cent/share = approximately $5,000,000
I agree Flipper! Thank you! And if you look very closely to the 2016-10K p.5 you can see the Compagny stated the same additional piece of information about closing enrollment when they are talking about lifting the hold by the FDA and also when they are talking about the self- imposed hold on screening in countries outside the US. It is my believe lifting the hold has nothing to do with closing the enrollment And by mention it twice that they are not going to enroll the last 17 of the planned 348 patients it is my opinion that the Company wants to make it clear that closing enrollment has nothing to do with lifting the hold!
Quote:
________________________________________
The trial was on partial clinical hold for screening of new patients for enrollment; however, the patients already in the trial continued to be treated in accordance with the trial protocol, without interruption. In December 2016, the Company announced that to date the regulators had not agreed to remove the partial hold, and the Company had determined that it would not enroll the last 17 of the planned 348 patients. Thereafter, in February 2017, the FDA lifted its hold. The Company had self-imposed a hold on screening in countries outside the US, this remains in place in agreement with the regulators, and the Company will not enroll the last 17 patients as announced in December 2016.
2016 10K - page 5
https://www.sec.gov/Archives/edgar/data/1072379/000114420417020754/v464066_10k.htm
“You think THAT indicates a successful trial? Celldex and IMUC showed immune responses.(Iclight)”
I know…” the proof of the pudding is in the eating”.
But i believe that her words are well thought out! For me the quote of Linda Liau is very, very meaningful!
Quote:
“I have a huge drive to prove that things that seem impossible can actually work,” said Liau. “When I first started working on brain tumor immunotherapy, everyone told me that you can’t mount an immune response in the brain. Now we know that’s not true.”
dd: 9/28/2017 http://medschool.ucla.edu/body.cfm?id=1158&action=detail&ref=1165
And i like also this interview (june 2016):
What is the biggest lesson you gained from business school? The biggest lesson I gained from business school is the importance of personal relationships and teamwork. True leadership is much more about “we” than about “me”.
What achievement are you most proud of in your professional career? Developing the first cellular vaccine (DCVax) for brain cancer.
And this is from april 2016:
quote
“When brain-tumor researchers are asked about the most promising areas for future study, both genetic profiling and immunotherapy consistently top the list, Dr. Liau says. UCLA is at the forefront of both fields. UCLA’s immune-based therapies currently in clinical trials use treatments that enable the immune system to kill tumor cells by targeting factors, known as immune checkpoint inhibitors, which impede the immune system from successful tumor control. In addition, Dr. Liau and her colleagues developed the first dendritic cell (DC)-based vaccine, known as DCVax, for brain-tumor patients to be used in humans. “The problem with brain tumors is that, despite treatment, they tend to come back,” Dr. Liau says. “The promise of immunotherapy and vaccines is that they can hopefully prevent the cancer from returning.”
Fifteen years ago, most experts believed it was not possible, because of the blood-brain barrier, for patients to mount an immune response to brain cancers. “We’ve found that these tumor vaccines can not only mount an immune response, but that a significant percentage of patients have had no recurrence for more than 10 years now, which for glioblastoma is very rare,” Dr. Liau says.
Currently, Dr. Liau and her colleagues at the UCLA Brain Tumor Center have begun to publish on genetic profiling and biomarkers to determine which patients are likely to fare well on immunotherapy. “Right now, we’re treating everyone the same way,” she says. “I am hopeful that in the next few years, we will have biomarkers that we can test either in the patient’s blood or via imaging. With these biomarkers, we will know in advance which patients will respond, and for those who won’t, we will work on other ways to treat the tumor.”
https://connect.uclahealth.org/2016/04/26/multipronged-approach-takes-aim-at-malignant-brain-tumors/
Happy New Year!
Maybe this helps:
Quote:
“I have a huge drive to prove that things that seem impossible can actually work,” said Liau. “When I first started working on brain tumor immunotherapy, everyone told me that you can’t mount an immune response in the brain. Now we know that’s not true.”
dd: 9/28/2017 http://medschool.ucla.edu/body.cfm?id=1158&action=detail&ref=1165
Exwannebe, i have some questions about you wrote
Quote:
“That is false. It has never been disclosed when the FDA hold was issued. We can safely assume it was about the start of Aug is all.
The hold was publicly discovered first in Germany because the German trial registry was properly updated while here in the US we allow the sponsors to update whenever they feel like.
The FDA hold was only publicly disclosed after it was obvious something was going on. Can not well keep it a secret when 100s involved at the sites have been informed the trial is on hold.
The reasonable relationship between the 2 is that the FDA issued a hold in the US. Then NWBO voluntarily issued the other holds before they where put on hold by the others acting on the FDA's information.
Just like with NASDAQ decision to quit before being kicked out. Some will assume that acting voluntarily somehow makes the situation less serious.
EDIT: On the reason to believe FDA came first:
If NWBO wanted the trial on hold, they could have put the entire trial on hold. So why did NWBO issue their voluntary hold only ex-US? Most likely because US was already on FDA hold. Also, why would the FDA suddenly see something forcing a hold at almost the exact same time as the ex-US hold?
Very convoluted logic to come up with a rational explanation of ex-US being prior to US. While the other direction is clear, once the FDA issued the hold it would make perfect sense for NWBO to hold the entire trial”
We know that LP said in a PR 12/08/2016 : "To date, the regulators have not agreed to remove the partial hold, but have allowed all of the patients in the Trial to continue being treated in accordance with the Protocol. The Company is pursuing ongoing dialog with regulators.
https://www.nwbio.com/nw-bio-provides-update-about-phase-3-trial-of-dcvax-l-for-newly-diagnosed-glioblastoma-multiforme-brain-cancer/"
Notice she is speaking of regulators = more than one. I think at that moment she is doing the very best to lift the hold on recruitment.
ON february 3, 2017 the FDA lifted the partial hold.
Quote:
________________________________________
"On February 3, the FDA lifted the partial clinical hold which had been in place on the Trial. As previously reported, the Company has been in an ongoing dialog with regulators. The dialog culminated in the FDA lifting the partial hold. As previously announced by the Company, and as the Company also informed the FDA, the Company has closed enrollment and is not going to enroll the last 17 of the planned 348 patients."
PR 2/6/17
https://www.nwbio.com/nw-bio-announces-lifting-clinical-hold-dcvax-l-phase-iii-trial-fda-progression-free-survival-events-reached-overall-survival-events-not-yet-reached/
I think its obvious that LL and even LP were very happy the hold on recruitment was lifted!
Quote:
"Dr. Linda Liau, Principal Investigator of the DCVax®-L Trial commented: “It is gratifying to have the hold removed from the Trial and exciting to see this Trial now moving towards completion, although of course the longer it takes for PFS and OS events to accrue, the better the patients in the Trial are doing.”
There are members on this board saying the FDA lifted the hold because the company announced they are not going to enroll the last 17 of the planned 348 patients. But when it is so easy to have the hold lifted why the self imposed hold in countries outside the US?
Quote:
"As previously announced by the Company, and as the Company also informed the FDA, the Company has closed enrollment and is not going to enroll the last 17 of the planned 348 patients"
Maybe “ gratifying to have the hold removed “ have something to do with RMAT designation.
Quote: "The request for RMAT designation must be made either concurrently with submission of an Investigational New Drug application (IND) or as an amendment to an existing IND. We will not grant a RMAT designation if an IND is on hold or is placed on hold during the designation review."
https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm537670.htm
But my question is why the self imposed hold on screening new patients by the Company in countries ex-US after the FDA lifted the hold? The voluntary hold remains in place in agreement with the regulators.
Quote:
________________________________________
"The trial was on partial clinical hold for screening of new patients for enrollment; however, the patients already in the trial continued to be treated in accordance with the trial protocol, without interruption. In December 2016, the Company announced that to date the regulators had not agreed to remove the partial hold, and the Company had determined that it would not enroll the last 17 of the planned 348 patients. Thereafter, in February 2017, the FDA lifted its hold. The Company had self-imposed a hold on screening in countries outside the US, this remains in place in agreement with the regulators, and the Company will not enroll the last 17 patients as announced in December 2016."
2016 10K - page 5
https://www.sec.gov/Archives/edgar/data/1072379/000114420417020754/v464066_10k.htm
So it looks to me they were doing everything to lift the hold by the FDA but they are not in a hurry to lift the hold in countries outside the US. Why is that? Its obvious they want no more patients in the trial in Europe and Canada. IMHO i think its not likely the FDA first issued a hold in the US. Then NWBO voluntarily issued the other holds before they where put on hold by the others acting on the FDA's information.
I believe the Company voluntarily issued a hold in Europe and Canada and i think it has something to do with a difference in recruitment conditions of patients. We know there was a change in 2014 in recruitment conditions of patients and i think that is the only difference between the trial in the US and the trial in countries ouitside the US. I don’t believe the pseudoprogression was the reason for the hold on screening. Pseudoprogression could be a big issue but when it was the reason for the hold ,why would you try everything to resolve the problem with the FDA and not with the regulators in countries outside the US?
The BRAIN TUMOUR CHARITY:
in 2016 the Organization asked prof.Garth Cruicksand to give a lecture :
About the German document see also discussion:https://investorshub.advfn.com/boards/read_msg.aspx?message_id=116048755
Sentiment_stocks thanks for the very great work!
I still have a few questions about the neurosurgeon Julius Fernandez who get his vaccin in London.
First i don’t think his wedding day ( wich was at the same time of his surgery) was 02 september 2015.( See AVII77Post 147107).
I found that on 02 September, 2015 there was a publication of more than 125 marriage licencies (one is Julius Fernandez, 42; Jody L.Wilson, 31) in the Commercial Appeal( i think a local newspaper) So, for me, his wedding day could be any day.I found it here: https://www.pressreader.com/usa/the-commercial-appeal/20150902/281981786352932
But we know from the neurosurgeon himself that he was diagnosted with brain cancer in the summer of 2015: https://vimeo.com/163043770
We also know that it was his request that he was allowed to marry Jody before surgery.(wavelenghty post 147059)
“Julius and his girlfriend, Jody, had been together for
several years, and Julius’s only request was that he be
allowed to marry her before undergoing surgery. We called
ahead and had the Child Life people prepare one of our
ICU rooms for the wedding and called for the hospital
priest to be there to perform the ceremony. By the time
Julius got to the hospital he was getting sleepy and was
unable to walk from his car into the hospital.
While the ceremony was taking place upstairs, our operating
room team was preparing for his surgery. By the
time Julius got to the operating room, he was no longer
following commands. Paul Klimo and I removed his glioblastoma,
and Julius made a speedy recovery.”
abc1212 i found a video from Dr. Julius Fernandez on vimeo.com/163043770.
The doctor said he was diagnosted last summer (2015) with maligne Brain tumor and he is doing OK.
We know from MD Frederick A.BOOP that he get his surgery immediately after diagnoses.
So i guess he was maybe one of the last patients in the trial and get his vaccinations in London okt-nov 2015. Placebo or DCVAX-L?
abc1212 can jou post the video from Dr.Julius Fernandez because this is from my phone and my last reply for today. Thanks!
Julius Fernandez, MDMemphis, TNJulius Fernandez,MD, passed away on February 22,2017, at the young age of 44.
Thats the MD who get DCVAX-L in London end 2015 or beginning of 2016.
See video 2017 AANS Frederick A.Boop, MD, FAANS min.30.18.
On YouTube : youtube.com/match?v=UZeZ8fWCKYs. Presidential Address from the 2017 AANS Annual Scientific Meeting-Frederick A. Boop,MD, FAANS
Min. 30.18.
U.K. July 18 , 2017- Mallincrodt plc today announced that StataGraft regenerative skin tissue is among the first products to be designated RMAT by the U.
S.FDA.
Nov.8 , 2017- Fortress Biotech today announced that the U.S.FDA has granded Cellvation's CEVA101 RMAT Designation for the Treatment of traumatic Brain injury.
Oktober 02, 2017 "Asterias Announces Two Significant Developments for Spinal Cord Injury Program.
"Also, the FDA granted the compagny's request for AST-OPC1 to be designated a RMAT under the 21st Century Cures Act.
So i found 11 granted: Humacyte, Enzyvant, jCyte , Vericel, Kias (Apr. 17, 2017), Bluebird, Juno Therapeutics, Athersys, Mallincrodt, Fortress Bio and Asterias Biotherapeutics.
See also article from nov. 27, 2017: FDA Clarifies and Expands Eligibility for RMAT Designation for Gene Therapies.
"In September, FDA disclosed that it already had 550 active investigational new drug applications (INDs) related to gene therapies, including 76 active INDs related to CAR-T cellular therapies. As of November 9, it has been reported that a total of 11 RMAT designations have been granted out of 31 requests.
VericelCorp . May 10,2017 : Vericel receives FDA RMAT Designation for lymyelocel T for the Treatment of Advanced Heart Failure due to Ischemic Dilated Cardiomyopathy.
Bliebird bio reports third quarter 2017 financial results: RMAT Designation grandes by FDA for LentiGLobin drug product in SCD.
Juno therapeutisch reporter third quarter 2017: Rmat designation for investigational drug JCARO17.