Life long Maverick: Seen it ALLl in 40 yrs of PROF. exposure as invest analyst/port mgr on the FRONT lines vs iHub Msg Bds.
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FDA Discusses RWD, RWE With Industry, Academia
Posted 19 July 2019 | By Zachary Brennan
Year End 2018
AVXL list of TOP Inst’l holders: Vanguard was a large Seller
Yrend 2018 List of AVXL’s TOP Inst’l Holder’s
Largest Inst’l Holder of 3.5 mln AVXL, Park West Asset Mgt SOLD all IMHO:
Believe it is the largest instl holder of AVXL SOLD the 3.1 mln of it's AVXL after 2.5 yrs of AVXL ownership and likely dumped the rest to essentially LOSE ~20%+MONEY on AVXL since late 2016!
Began with:PARK WEST ASSET MANAGEMENT LLC 12/31/2016 1,500,000 1,500,000 New 8,790
PARK WEST ASSET MANAGEMENT LLC 03/31/2017 2,962,090 1,462,09097.47
PARK WEST ASSET MANAGEMENT LLC 06/30/2017 3,302,827 340,737 11.50 14,665
Ended withPARK WEST ASSET MANAGEMENT LLC 03/31/2019 3,495,615 0 0.00 8,984
Source: nasdaq.com
It has actually transpired just like I envisioned!
Lots of industry developments since Park West began investing in late 2016 without much AVXL countering progress likely were their reasons to sell: I should know since I am a retired Money mgr/analyst
Moreover, it is exceedingly rare that AVXL being added to Russell Indices and the ADD (AVXL) declines
and precipitously.
Pending SEC Shelf dilution; LPC (atm)shares.
We'll find out by Aug 15th! who the seller and buyer was for 2Q 2019
BTW:
https://investorshub.advfn.com/boards/profilea.aspx?user=674987
https://investorshub.advfn.com/boards/profilea.aspx?user=486527
DIFFERENT STROKES FOR DIFFERENT FOLKS
Those using Fidelity Investments: re CEO Linda Powers: "Get NWBO shs in YOUR NAME"
FAR Behind DC VAX L is DFFN's INTACT GBM Ph3 trial with PR today
https://clinicaltrials.gov/ct2/show/NCT03393000
FAR Behind DC VAX L is DFFN's INTACT GBM Ph3 trial with PR today
https://clinicaltrials.gov/ct2/show/NCT03393000
Thanks Doc_Logic: I have been on the same page re DIRECT; UCLA.
Great to see your exposition for the board at large given your clear ability to deal with the panoply of characters for ALL these years.
Hopefully ALL of what the TRUE (non Piss/Moan)longs have postulated, and most especially re the resounding updates from
Dr. Carlo Rago PHD in Immuno-Oncology become Oncology's Big Ben in London:
https://www.scribd.com/document/411229128/A-Dendritic-Cell-Cancer-Vaccine-Shines-Brighter-for-Glioblastoma-Patients
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https://investorshub.advfn.com/boards/read_msg.aspx?message_id=131963240
Nothing has changed!
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Thks biosectinvestor re: PACT Pharma is part of Google Ventures:
BIG NUGGETS vs typically only morsels: priv. PACT Pharma PR on Cancer Vaccines; C_ART; UCLA re
potential game changing technology.
Personalized gene-edited immune cell therapy for patients with solid cancers: New data establishes approach for verifying patient-specific cancer mutation targets
Published: Jul 21, 2019
PACT's gene-edited T cells were observed to kill tumor cells by targeting patient-specific tumor mutation targets in non-clinical testing
The company is launching clinical studies of personalized targeted immune cell therapy for patients with solid cancers
SOUTH SAN FRANCISCO, Calif., July 21, 2019 /PRNewswire/ -- PACT Pharma, a leader in the fields of cancer immunology and cell therapy in collaboration with a team at UCLA, presented new data demonstrating for the first time the ability to identify mutation targets unique to each person's cancer and verify the cancer specificity of multiple cloned T cell receptors. Each patient's cancer has a private signature of mutations, creating an opportunity to develop fully personalized immune therapies that have the potential to eradicate tumor cells. Defining these cancer mutation targets for each person, known as neoantigens, enables the company to use its proprietary gene engineering technologies to manufacture an immune cell therapy product for each person with cancer. The presentation was at the AACR's Special Conference on Immune Cell Therapies for Cancer. The company has begun enrolling patients with advanced solid tumors in its Phase 1 dose escalation study of NeoTCR-P1, an autologous gene-edited TCR T cell product that targets personalized neoantigens (https://clinicaltrials.gov/ct2/show/NCT03970382).
"These exciting results open a bold new frontier for directing a person's own immune system to treat patients with solid cancers, an area that hasn't yet seen the successes of immune cell therapies that we have seen for blood cancers," said PACT's Chief Executive Officer Alex Franzusoff, Ph.D. "While it is early, the results demonstrate the possibility for PACT's approach to ignite a patient's immune response directly against their unique tumor mutation signature, within a clinically relevant timeframe, with potential applicability to most cancers and all ethnicities across the globe."
Today's data is relevant because they show that mutations that build up in tumors, creating the unique tumor mutation "signature" that drives each patient's cancer, have already triggered each person's immune system to target those unique mutations, but at a very low level. Now those low-level targeted immune responses can be analyzed with greater accuracy, used to manufacture a truly personalized treatment that is tailored for each patient with cancer, and evaluated in clinical trials.
The company's approach is designed to select and confirm tumor-exclusive mutations to empower a patient's immune system to target their specific cancer. PACT utilizes bioinformatics to identify the mutation blueprint of each person's tumor, and then uses its barcoded snare technologies to capture pre-existing T cells from the blood that already recognize and target the unique mutations. From that group, a proprietary selection platform is used to identify the ideal T cell receptors for specific mutations. Once the target is authenticated, the company uses non-viral gene editing to engineer the ideal mutation-targeted T cell receptors into T cells from the same patient. When reinfused back to the patient, these T cells have the potential to eliminate tumor cells that express these unique mutations.
"The results presented today show that PACT's approach of neoantigen-specific T cell capture and non-viral precision genome engineering is indeed groundbreaking and promising for a new chapter in personalized immune cell therapies for patients with solid cancers," said Antoni Ribas, a professor of medicine at the Jonsson Comprehensive Cancer Center at the University of California, Los Angeles, who is a co-author of the study and also a co-founder of PACT. "The demonstration that T cell receptor-engineered T cells using the PACT approach can specifically kill that same person's cancer cells is based on the analysis of immune cells captured from the blood of a patient with a long-lasting response to anti-PD-1 therapy."
The evolution of personalized immune-oncology treatments
Recently, a new generation of personalized cellular therapies for cancer has emerged. Rapid sequencing technologies, bioinformatics, and genetic/cellular engineering — in addition to a deeper understanding of clinical immunology and a renaissance in immunotherapy — have made these advancements possible. Designer immune-oncology treatments have been developed, including CAR-T cell therapies, cancer vaccines and tumor-infiltrating lymphocyte therapies.
While transformative, these therapeutic approaches face limitations. CAR-T cells only recognize shared cancer targets expressed on the cell surface, which, while effective for blood cancers, have not been applied successfully to patients with solid cancers, and cancer vaccines are often too slow to address a rapidly growing tumor burden. Further, tumor-infiltrating lymphocytes can be impractical—and at times even impossible—to generate for every patient due to the difficulty of isolating limited numbers of specific tumor-targeting immune cells and then needing to greatly expand their numbers for patient dosing. In the case of expanded immune cells in particular, they often become exhausted before reinfusion, which may limit their value for eliminating the cancer throughout the body.
In order to truly tailor cancer treatments to individuals, the therapy must target each patient's unique cancer signature--including different tissue compatibility receptors of the immune system, or HLA, in each person. These HLA receptors are key to immune recognition, which is what limits organ sharing between people. PACT's approach captures this nuance. Custom tailored, yet for a global population, PACT's approach is designed to select and authenticate tumor-exclusive mutations to empower the patient's immune system to target their specific cancer for a lasting effect. PACT plans to further investigate the safety and effectiveness of this technology in a series of clinical trials, starting with a first-in-human Phase 1 clinical trial at clinical sites in California.
ABOUT PACT –
PACT Pharma is an independent, privately funded company, based in South San Francisco, California, developing transformational personalized TCR-T cell therapies for the eradication of solid tumors and is now enrolling patients in its first-in-human Phase 1 clinical studies at several key academic centers of the CIRM-funded Alpha Clinic network, in California.
PACT Pharma's accomplished co-founders, David Baltimore (Nobel Laureate), Antoni Ribas, Jim Heath, Terry Rosen and Juan Jaen, established the company in 2016 and launched the company in early 2017. The PACT team raised $31 million in 2016 and secured another $95 million in financing in May of 2018 from Alphabet Inc.'s venture arm GV Investments, Canaan Partners, Casdin Capital, Droia, Foresite Capital, Invus, Pontifax and Wu Capital, including investment from AbbVie Ventures and Taiho Ventures.
PACT Pharma's technology is designed to reprogram a patient's immune system cells to target their own cancer. The process involves taking a biopsy of a person's cancer tissue, sequencing the tumor's DNA and then using predictive algorithms and proprietary technologies to engineer T-cells involved in the body's immune response to combat that specific disease as it expresses itself in the patient. The last step is injecting the cocktail back into the patient.
Tumor mutation targeting is programmed into the patient's own T cells to seek out and kill the tumors. Using (non-viral) precision genome engineering, the mutation-targeted T cell receptors (neoTCRs) are designed to replace the pre-existing T cell receptors of fresh CD8 and CD4 T-cells collected from that same patient followed by minimal expansion in closed systems for re-infusion into the patient. These patient-specific neoTCR-P1 cells are formulated to immediately kill neoantigen-expressing tumors, together with a deep reservoir of 'ready-to-go' neoTCR-P1 cells for long term persistence and which may be capable of rapid expansion to prevent future cancer recurrence.
CONTACT: William Nevius, wnevius(at)canaan.com
View original content:http://www.prnewswire.com/news-releases/personalized-gene-edited-immune-cell-therapy-for-patients-with-solid-cancers-new-data-establishes-approach-for-verifying-patient-specific-cancer-mutation-targets-300888340.html
SOURCE PACT Pharma[/quote]
In Fast Paced Emerging BioTech's best to be UNinvested versus the HIGH cost of learning on the job which 99% have experienced here.... or in other emerging biotechs.
In my five years here I have found that making timely critical investment/judgemental assessments, is totally absent! and explains why oil does not mix with water or can't teach an old dog new tricks.
Making timely and correct investment judgements is the be all and end all! of INVESTING: A mantra I've practiced in all my life long undertakings.
That's why:
DIFFERENT STROKES FOR DIFFERENT FOLKS
46 yr old London film producer is an 8 yr GBM survivor detailing his wide ranging therapy experiences (DC as well!)Father with brain tumour has lived EIGHT years beyond his prognosis
July 18 StatNews Plus' PDF The past-- and future---- of Alzheimer's research
By SHARON BEGLEY and MATTHEW HERPER JULY 18, 2019
July 18 StatNews Plus' PDF The past-- and future---- of Alzheimer's research
By SHARON BEGLEY and MATTHEW HERPER JULY 18, 2019
Over two yrs later, a NEEDED Update on MOTIVATIONS: Why UCSF's Yonemura vs NWBO trial to distract NWBO and make needed FUNDING DIFFICULT & ALIENATE DCVAX L
I have suspected and posted it is because of THE SEAN PARKER CANCER INSTITUTE funding and naming as the CEO UCSF Jeff Bluestone for the last 2 yrs
Versus that of Sentiment's DMSB's brother's Danish Immuno co.
re Sentiment's post
Boosting CAR-T to treat solid tumors with a vaccine
by Angus Liu | Jul 11, 2019 2:00pm
2nd Earthquake along the Pacific’s “Ring of Fire”
Quake of magnitude 6.5 hits northwest of Canada's Vancouver island: USGS
An earthquake of magnitude 6.5 struck northwest of Canada's Vancouver island, the United States Geological Survey (USGS) said on Thursday.
There was no tsunami warning or immediate reports of damage or casualties in the quake, which the agency said hit at a depth of 10 km (6 miles) about 225 km (140 miles) northwest of Port Hardy.
(Reporting by Clarence Fernandez; Editing by Himani Sarkar)
Source Reuter’s
Did see on two different trips most all the wonders of immense Alaska via a cruise (Juno, Alk had 110 yr record high temps recently of 85 degrees!) and a road trip from Gulf Islands; Victoria Gardens south end Vancouver Island (to taking car ferry to “Sunshine Coast”); biked Vancouver’s fabled Stanley Park & surroundings: North America’s most expensive residential real estate market due to the Chinese since mid 1990’s! (my aunt lived there) and in last decade ie daughter of founder of Huawei detained for US extradition.
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Vascepa re INFLAMMATION & CANCER
New Markers For Alzheimer's Disease Could Aid Diagnosis And Speed Up Drug Development
Vascepa re Alzheimer’s
New Markers For Alzheimer's Disease Could Aid Diagnosis And Speed Up Drug Development
Aug 2015 NWBO PR:
“The only change in status of the trial is that new screening of patient candidates for the trial has been temporarily suspended while the Company submits certain information from the trial for regulatory review.
Such screening involves the initial evaluation of patient candidates to determine whether they meet eligibility criteria for the trial (e.g., whether they are within the eligible age range, do not have certain viral diseases, etc.)
Some blogs and social media comments have noted that the EudraCT trials database in Europe states that there is a “Temporary Halt” of the trial in Germany. In actuality, the trial status in Germany is that the trial is ongoing as noted above, and the Company has only undertaken a temporary suspension of new screening.
The Company has sought to have the EudraCT listing corrected, but the database includes only certain pre-specified categories and there is no category that corresponds to a temporary suspension of new screening only, while a trial is ongoing.”
https://nwbio.com/nw-bio-confirms-phase-iii-trial-of-dcvax-l-for-gbm-brain-cancer-is-ongoing/
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The Company is in the process of preparing the trial information for regulatory review and anticipates submission within the next couple of weeks.
From the option playing dislodged jockey’s megaphone a few years ago:
“It's sad and sickening to me. I've experienced losses like that several times. I can remember the first time just laying on the floor looking up at the ceiling and feeling <nothing>. Like I was an empty shell. It took me weeks to shake that. I went broke a second time too, and then finally got it. Or at least I think so ;) But I would rather go through both again than be "stuck" (really you could have escaped many times) in a stock that loses 95% of its value over 10 stretched out months. Anguish! “
After JT’s recent blowout PR happened on here.
Happy July 4th JL et all
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This would fit NWBO circumstances: FDA’s Real World Evidence (RWE)
Sentiment: Apparently you missed the contents......
maverick_1 Member Level Wednesday, 06/26/19 03:04:25 PM
Re: flipper44 post# 234687
Post # of 234710
REAL TIME ONCOLOGY REVIEW ONLY FOR FDA APPROVALS w/Mktg application::
Quote:
The FDA has started using real-time review of drug applications to evaluate clinical data as soon as the trial results become available. This means that theFDA can approve a new indication soon after an applicant files a marketing application[.
https://www.fda.gov/drugs/real-time-review-drug-applications-now-reality-september-20-2018-issue
GET BACK TO BASIS of RTOR vs a diversion.
On sand will get washed away..
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https://woodfordfunds.com/words/blog/fund-suspension-extension/
DIFFERENT STROKES FOR DIFFERENT FOLKS
Caveats otherS have yet to point out in the last week re NWBO GBM Template for German Reimbursement was last cited by CEO Linda Powers (5 yrs ago!) as reimbursement by Sickness Fund of which there are many..
Additionally, DC VAX L will likely differ from that of Novocure’s Optune as the later is a medical device and at ~US$20K/per MONTH clearly EXPENSIVE: just look at NVCR’s Optune % rate of reimbursement by carrier in the US!
Defer to others with specialized experienced in such matters.
DIFFERENT STROKES FOR DIFFERENT FOLKS
IN the original article I posted with:
Too much NOISE (par for my 5 year experience here) re Novocure! ETC! ETC!
ALL one need do is their OWN Due Diligence (not doing what each one should do!) of reading and digesting recent NVCR 10K and press releases all found:
https://www.novocure.com/
BTW it is way beyond what Flipper says in Europe... that it is just Germany!
The King of the Mountain does NOT exist unless you are recognized titan with RESULTS: like Gates; Bezoes; Dalio; Dimon.
Until you do the above it is ALL HEARSAY!!
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FWIW: 2 Stocks That Could Be the Next Biotech Buyouts