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FDA asked PMCB How Will You Conduct Clinical Trials during COVID-19 Pandemic?
Guaranteed a question asked of PMCB during the 30 day review.
PMCB will answer this COVID-19 with FDA satisfaction and implement into trial.
Think of it not only the enormity of PMCB's pancreatic cancer solution with gateway to providing other types of cancer and diabetes solutions; all done while implementing COVID-19 best practices!!!
Check out the following FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency
Guidance for Industry, Investigators, and Institutional Review Boards
SEPTEMBER 2020 at this link
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency
Download at https://www.fda.gov/media/136238/download FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency Guidance for Industry, Investigators, and Institutional
Review Boards
Updated on September 21, 2020
COVID-19 is an emerging, rapidly evolving situation.
What people with cancer should know: https://www.cancer.gov/coronavirus
Guidance for cancer researchers: https://www.cancer.gov/coronavirus-researchers
Get the latest public health information from CDC: https://www.coronavirus.gov/
Get the latest research information from NIH: https://www.nih.gov/coronavirus
Cornell Taking Projects Like PMCB From Bench To Clinics:
While we wait in anticipation for FDA IND decision check out 3 videos from Cornell Pancreatic Pancreas Program at New York-Presbyterian/Weill Cornell Medical Center in New York City.
Pancreatic Disease (Part 1) - Dr. Michael D. Lieberman
Signing off until IND FDA decision announcement day.
All the best PMCB longs! Everyone Be Well! Be Safe!
WOW! PMCB Included In Pancreatic Cancer Market Research Report – Global Forecast to 2025 – Cumulative Impact of COVID-19
Published: Sept. 14, 2020 at 10:16 a.m. ET
This is a $4,500 report and according to this article 7.2.6 PharmaCyte Biotech, Inc. is in the report. WOW!!!
See this link for full article.
https://www.marketwatch.com/press-release/pancreatic-cancer-market-research-report-global-forecast-to-2025-cumulative-impact-of-covid-19-2020-09-14
Table of Contents
1 INTRODUCTION
2 Research Methodology
3 Executive Summary
4 Pancreatic Cancer Treatment Market Variables, Trends & Scope
4 Pancreatic Cancer Treatment Market: Affected Region Estimates & Trend Analysis
5 Pancreatic Cancer Treatment Market: Treatment Estimates & Trend Analysis
6 Pancreatic Cancer Treatment Market: Regional Estimates & Trend Analysis, by Affected region & Application
7 Competitive Landscape
7.1 Strategy framework
7.2 Company Profiles
7.2.1 Eli Lily and Company
7.2.2 Celgene Corporation
7.2.3 Hoffmann-La Roche AG
7.2.4 Amgen, Inc.
7.2.5 Novartis AG
7.2.6 PharmaCyte Biotech, Inc.
7.2.7 Clovis Oncology
7.2.8 Teva Pharmaceutical Industries Ltd.
7.2.9 Merck & Co., Inc.
7.2.10 Pfizer, Inc.
PMCB designed to implement PANCAN Promise once IND approved?
With Supreme Court Justice Ruth Bader Ginsburg Death yesterday from Pancreatic Cancer (RIP RBG), RBG's fighting spirit will bring intense World awareness to Pancreatic Cancer in next few weeks!
Precision Promise is PanCAN’s groundbreaking service to accelerate new treatment options for pancreatic cancer patients. We design and manage pancreatic cancer research and clinical trials with a collective of leading experts with whom we collaborate in these efforts. This includes basic and translational research funding, key opinion leader and industry partnerships, early and late stage clinical development. In addition, we will investigate supportive care measures, and we will analyze extensive patient data to better understand what makes every patient’s tumor unique. Precision Promise is designed to serve as a catalyst to accelerate pancreatic cancer drug development, de-risk industry participation, increase clinical trial enrollment and transform the way clinical research is done for pancreatic cancer patients.
see this link for more details https://www.pancan.org/research/precision-promise
Where is PanCAN’s Precision Promise adaptive clinical trial located, and when will the sites open?
There are 15 initial Clinical Trial Consortium sites across the United States. The sites will start opening in early 2020, with the majority expected to open throughout the year.
Weill Cornell Medicine (New York City, NY)
Principal investigator: Manuel Hidalgo, MD, PhD
Principal investigator: Eileen O’Reilly, MD
Moores Cancer Center at UC San Diego Health (San Diego, CA) – SITE OPEN
Principal investigator: Aaron Miller, MD
Perelman School of Medicine University of Pennsylvania (Philadelphia, PA)
Principal investigator: Gregory Beatty, MD, PhD
Perlmutter Cancer Center/NYU Langone Health (New York City, NY) – SITE OPEN
Principal investigator: Diane Simeone, MD
The University of Chicago (Chicago, IL) – SITE OPEN
Principal investigator: Hedy Kindler, MD
The University of Texas MD Anderson Cancer Center (Houston, TX) – SITE OPEN
Principal Investigator: Shubham Pant, MD
UC San Francisco Helen Diller Family Comprehensive Cancer Center (San Francisco, CA)
Principal investigator: Andrew Ko, MD
University of Florida Health – Cancer Center (Gainesville, FL) – SITE OPEN
Principal investigator: Thomas George, MD, FACP
Virginia Mason Medical Center (Seattle, WA) – SITE OPEN
Principal investigator: Vincent Picozzi, MD
Washington University School of Medicine (St. Louis, MO) – SITE OPEN
Principal investigator: Kian-Huat Lim, MD, PhD
Even though this is set up for first and second line treatments, the PI network is shown that PMCB can plug into managed by Principal investigator: Manuel Hidalgo and his PI peers!
PRECISION PROMISESM is a service mark of Pancreatic Cancer Action Network, Inc.
Could PMCB reverse split be a vital good move like Curis did?
Of course PMCB's IND needs FDA approval to make this work!
Check out this story
Curis shares soar after the biotech executes a reverse stock split
at this link
https://www.proactiveinvestors.com/companies/news/197867/curis-shares-soar-after-the-biotech-executes-a-reverse-stock-split-197867.html
Curis Inc. (NASDAQ:CRIS) shares were flying high Wednesday after the Massachusetts-based biotech executed a 1-for-5 reverse stock split late Tuesday.
The split occurred May 29, 2018 at 5:00 pm ET and investors sent shares of the biotech firm higher immediately. A reverse split decreases the total number of the company's outstanding shares and concurrently boosts the share price.
The stock closed nearly 2% higher to US$0.46 Tuesday and jumped nearly 7% to US$0.49 after hours. It nearly quadrupled in pre-market action today, and then picked up strong in the regular session, rising as much as 16% before settling back to a 5% gain to US$2.40.
Curis had four strong drug candidates in its product pipeline. It’s currently carrying out Phase 2 clinical trials for CUDC-907, an oral dual inhibitor of HDAC and PI3K, in patients with relapsed lymphoma.
The biotech’s second drug candidate CA-170, was currently undergoing investigation in a Phase 1 clinical trial in patients with advanced solid tumors and lymphoma. Another oral small molecule drug candidate, CA-4948, is in Phase I clinical trials, while CA-327, an oral small molecule drug candidate is still in the preclinical stage.
Looks like many small biotechs have to do reverse splits when they have a pipeline (no profits) and need to get to next step to make it to revenue, profitability, buyouts and other!
Diana you are correct - Dr Manuel Hidalgo is the Principal Investigator not CMO!
Principal Investigator: Dr Manuel Hidalgo
Chief of the Division of Hematology and Medical Oncology at Weill Cornell Medicine and NewYork-Presbyterian/Weill Cornell Medical Center
The E. Hugh Luckey Distinguished Professor of Medicine, Dr. Hidalgo comes to Weill Cornell Medicine and NewYork-Presbyterian/Weill Cornell Medical Center from Beth Israel Deaconess Medical Center in Boston, where he served as chief of the Division of Hematology as well as clinical director of the Rosenberg Clinical Cancer Center. He is also the Theodore W. and Evelyn G. Berenson Professor of Medicine at Harvard Medical School and deputy associate director for clinical sciences at the Dana-Farber/Harvard Cancer Center.
A respected oncologist and premier investigator, Dr. Hidalgo’s work has centered on translational and clinical research in anticancer drug development with a particular emphasis in gastrointestinal cancers. He has developed, tested and helmed the early clinical development of more than 50 new anticancer agents for pancreatic and other solid tumor cancers. Three of those agents, including nab-paclitaxel, are now approved by the U.S. Food and Drug Administration for treatment of GI cancers, including pancreatic cancer. His team also pioneered the development of a personalized cancer model using mice, called mouse avatars, to pre-test cancer treatments.
The Silent Mega Value-Add of PMCB - AI Big Data!
The most important value of PMCB is meeting unmet needs for those suffering from Pancreatic Cancer. (this will multiply exponentially with other applications)
In doing so an enormous amount of big data will be collected. So what is big data worth? A report from James Cattell at McKinsey states that big data can add $100 billion in value to the pharmaceutical industry
Steve Jobs died of Pancreatic cancer, so I would think that most leading tech companies foundations like Apple, Microsoft, Google, Amazon, Tesla, Oracle and others are looking to partner with with companies like PMCB because of their huge potential with big data, Artificial Intelligence and other next gen tech possibilities.
Know anyone on PMCB's Board of Directors with ties to tech industry?
Thomas C. K. Yuen was appointed to PMCB's Board in May 2017. Mr. Yuen’s stellar career is exemplified by his global entrepreneurial experience and extraordinary leadership. He co-founded Irvine-based AST Research, Inc. (AST) in 1981. AST was an early pioneer of the computer industry, and the company has been referred to as “the flagship of innovation in the PC era.” Mr. Yuen served as AST’s Co-Chairman and Chief Operating Officer from August 1987 to June 1992. Under his leadership, AST became a Fortune 500 company in 1991, and its stock was named the “Best Performing NASDAQ Stock” of that year.
The Growing Importance of Big Data in the Pharmaceutical Industry
https://www.smartdatacollective.com/growing-importance-big-data-pharmaceutical-industry/
Pentagon taps Google for AI project to help veterans battling cancer
https://nypost.com/2020/09/03/pentagon-taps-google-for-project-to-help-veterans-with-cancer
Cornell Research (know anyone that works at Cornell? (Dr. Manuel Hidalgo - PMCB IND CMO)
Cancer and Big Data Analytics
Olivier Elemento applies big data analytics and high-performance computing to cancer prevention, diagnostics, treatment, and cure.
https://research.cornell.edu/news-features/cancer-and-big-data-analytics
What milestone removes "SCAM" from this site?
PMCB IND FDA approval, PPS 10 cents, 50 cents $1.00 or more, cure for everything on face of planet or other?
This has been an amazing blog site for researching pros and cons to learn about PMCB!
Just saying this site will be even more amazing keeping up to date with real time accurate events.
Back To Witness PMCB Better Than Ever Bringing the Ball Across the IND FDA Goal Line For Approval and Beyond!
Selection of proven Dr. Jose Iglesias is a big win to quarterback the team with Legendary coach Dr. Manuel Hidalgo as the Principal Investigator for Clinical Trial in Pancreatic Cancer
“Dr. Hidalgo is a leading authority in oncology who has special expertise in pancreatic cancer and will be vital in our efforts to further elevate the cancer enterprise at Weill Cornell Medicine and NewYork-Presbyterian,” said Dr. Peter Schlegel
https://news.weill.cornell.edu/news/2019/03/dr-manuel-hidalgo-named-chief-of-the-division-of-hematology-and-medical-oncology-at
Dr. Jose Iglesias is know to attract investors:
Check out this link for current Dr. Jose Iglesias CMO position count NEA, 8VC, Amgen Ventures, Lux Capital, Menlo Ventures, Pear Ventures, Allen & Company, Nest.Bio, Omega Funds, and LifeForce Capital among its investors.
https://www.businesswire.com/news/home/20200303005309/en/Senti-Biosciences-Announces-Dr.-Jose-Iglesias-Chief
Who is investing in Pancreatic Cancer Research?
Exciting News: $15 Million Proposed for Pancreatic Cancer Research Program at the Department of Defense
https://www.pancan.org/news/exciting-news-15-million-proposed-for-pancreatic-cancer-research-program-at-the-department-of-defense/
Since 2003, PanCAN, working in partnership with generous donors, has invested approximately $126 million, including our competitive Research Grants Program and leading-edge scientific and clinical initiatives
https://www.pancan.org/research/increasing-pancreatic-cancer-research-funding/
Funding Sources list
https://www.pancan.org/research/resources-for-scientists/funding-sources/
When IND approved by FDA there will be ample funders for PMCB!!!
Patents Assigned to Hai Kang Life Corporation Limited
check out patents at these links
https://patents.justia.com/patent/10379101
https://patents.justia.com/assignee/hai-kang-life-corporation-limited
Things can get very interesting when FDA approves PMCB/Hai Kang Life solution.
Defending a patent can draw revenues from a few sources:
Licensing, suing others in violation with damages from cease-and-desist and other.
"The present invention relates to a biochip for the determination of the concentration of one or more types of specific biomolecules in a sample and its fabrication, for example particularly, but not exclusively, a biochip and its fabrication."
Any patent lawyers in the house?
Hai Kang Life Promotional Video
check out this link
Will PMCB Cell Therapies Aid in Fight Against Severe Acute Respiratory Syndrome Deaths Like Coronavirus?
Brilliant video called Part 5: The Critical Patient that describes for the layperson attacking at the cell level with Coronavirus. see this link
I like your logic. Could this PMCB relationship be the new novel virus detection and treatment platform?
To further support what you are saying check out The Quest for a Pandemic Pill Can we prepare antivirals to combat the next global crisis? Just written by Matthew Hutson, a science writer for The New Yorker Magazine at
https://www.newyorker.com/magazine/2020/04/13/the-quest-for-a-pandemic-pill
"And so every time a new virus appears we scramble for a new treatment. Our usual antiviral approach is, as researchers say, “one bug, one drug”; often, it’s no drug. Ho has spent forty years fighting the aids epidemic, which has killed thirty million people and still kills nearly a million a year; he has seen three coronaviruses ambush us in the past two decades. Like many scientists, he’s tired of being behind the ball. He’d like to see a penicillin for viruses—one pill, or, anyway, a mere handful—that will eliminate whatever ails us. He and his colleagues aim to have these next-generation drugs ready in time for the next pathogen. “We have to be proactive,” he told me. “We must not be in a position of playing catch-up ever again.”
#1 PMCB BEST BIOTECH STARTUP HONORS?
PMCB can look at and be even better than #1. NOTABLE LABS - Best Overall Biotech Startup platform model. check out this video https://notablelabs.com
PMCB can lead in the era of next gen medicine (personalized and precision-medicine) https://www.webmd.com/cancer/precision-medicine#1 and https://www.nih.gov/about-nih/what-we-do/nih-turning-discovery-into-health/personalized-medicine
#1 Best Biotech Startup - Ranking - Notable Labs
Notable Labs is our #1 ranked, best biotech startup. Notable Labs is a drug testing service to help oncologists identify actionable treatment options for people with blood cancers. source https://www.angelkings.com/biotech-startups
So why is Notable Labs ranked #1 out of the thousands of biotechnology startups that exist? One answer: the team + the product are absolutely unbeatable. With leading engineers and bio-scientists, Notable Labs is giving near rapid results and processing to help doctors best deliver treatment options for patients. Additionally, Notable Labs’ product offering is creating personalized cancer treatment options that could end up saving thousands of lives each year.
PMCB Value Meeting Unmet Needs Plus Valuable Data!!!
To understand the value of data of PMCB check out these 2 videos
GSK: How Self-service Data Advances Drug Discovery at this link click on picture to watch video https://streamsets.com/customers/gsk
National Comprehensive Cancer Network PMCB Cancer Solution Roadmap
Great reference site at this link for GUIDELINES FOR TREATMENT OF ALL Types of CANCERS https://www.nccn.org/professionals/physician_gls/default.aspx#site
Here is the Pancreatic Adenocarcinoma link showing https://www.nccn.org/professionals/physician_gls/default.aspx#pancreatic
NCCN Guidelines with NCCN Evidence Blocks™ – About NCCN Evidence Blocks™
NCCN Guidelines
NCCN Framework for Resource Stratification of NCCN Guidelines (NCCN Framework™)
Basic Resources
Core Resources
Enhanced Resources
NCCN Guidelines for Patients
NCCN Educational Events and Programs
NCCN International Translations/Adaptations
About the NCCN Biomarkers Compendium® at this link https://www.nccn.org/professionals/biomarkers/default.aspx
Based directly on the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®), the NCCN Biomarkers Compendium® contains information designed to support decision-making around the use of biomarker testing in patients with cancer.
First, the importance of PMCB IND results working for Pancreatic to meet unmet needs, then the sky is the limit for roadmap for all other types of cancers. (diabetes and others as well)
Filter the noise everything is fact based from this point on!
FYI:
The NCCN Annual Conference Friday, March 20, 2020 - Sunday, March 22, 2020 attracts more than 1,650 registrants from across the United States and the globe including oncologists (in both community and academic settings), oncology fellows, nurses, pharmacists, and other health care professionals involved in the care of patients with cancer.
see this link http://www.cvent.com/events/nccn-2020-annual-conference/event-summary-347d73841d1a4130baf20ebb7a5bfc81.aspx
Cheers PMCB and fellow longs!!!
Alex Trebek discusses the latest in his cancer battle
"We may try a new protocol, a different chemo or something in the trial stage that is not chemotherapy," he said, adding, "I don't mind experimenting. I've got nothing to lose, so let's go for it."
Rest of story @ https://www.msn.com/en-us/health/health-news/alex-trebek-discusses-the-latest-in-his-cancer-battle/ar-BBYtee1?ocid=spartandhp
All the best to PMCB and longs in 2020!!! (good health to those not longs as well)
Why is PMCB holding share holders/board meeting on 9/11?
9/11 day is one of the most hollowed grounds and significant events in history.
News on this day should be to remember, respect and create model positive solutions to improve life!
Will the news for PMCB be significant on 9/11 to honor this spirit with important news about improving life?
I certainly hope so.
World Congress on Pancreatic Cancer and Liver Diseases October 23-24, 2019 | Tokyo, Japan
Theme: Daring Innovations in Enriching the HEALTH against Pancreatic and Liver disorders
https://pancreas.cancersummit.org
Seems like this event would reach both Pancreatic Cancer and Diabetes interests for PMCB and not too far from Austrianova to attend!
Perhaps the Board meeting on 9/11 will disclose the roadmap of things already decided for the public to know?
Pharmacy companies dealing with Pancreas cancer and Liver disease drugs
Amgen
Astellas
AstraZeneca
Bayer
Bristol-Myers Squibb
Celgene Corporation
Clovis Oncology
Eli Lily and Company
Gilead Science Inc.
GlaxoSmithKline Plc
Hoffmann-La Roche AG
Johnson & Johnson
Merck & Co
Novartis
Otsuka
Pfizer
PharmaCyte Biotech, Inc.
Roche
Sanofi
Takeda
Teva Pharmaceutical Industries Lt
Prayer for the healing of cancer.
Dear Lord, You have taught me that faith as small as a mustard seed can grow into an amazing tree. Today I give you my little seed of faith. I place it firmly in the ground of your word. I water it with truth. The warmth of your love will make it grow. Today I ask by faith that you would bring healing from cancer. I place my trust in you. May this seed sow healing into every area where the tumour has emerged. May it grow into a strong work, redeeming and restoring with great strength and power. With gratitude and love. Amen.
Steve Jobs dies a billionaire, with a fortune of $7 billion, at the age of 56 from pancreatic cancer, and here are some of his last words....
“In others eyes, my life is the essence of success, but aside from work, I have a little joy. And in the end, wealth is just a fact of life to which I am accustomed.”
“At this moment, lying on the bed, sick and remembering all my life, I realize that all my recognition and wealth that I have is meaningless in the face of imminent death. You can hire someone to drive a car for you, make money for you – but you can not rent someone to carry the disease for you. One can find material things, but there is one thing that can not be found when it is lost – “LIFE”.
So, having family, friends, and people to talk to is TRUE HAPPINESS!
I appreciate those on this board with like-minded-interests for PMCB to be successful by helping those in need providing solutions to save and improve lives!
Totally agree with your perspective. Brings sanity and reality to this board! Thank you!!!
PMCB is much bigger than this board to make a difference in the world!
One of the best life lessons I've ever learned is from terminally ill kids experiencing a dream vacation with their families in Orlando at Give Kids The World.
Many of the kids faced odds that they would not make it to their next birthdays. I volunteered as often as possible here and the message from the kids was that they only wanted to focus on having a happy time in their vacation to be like everyone else and not focus on the their life threatening illnesses such as cancer.
The goal of course was to find cures and all involved dreamed of a day that they "Loved to be able to close the this place down" because of cures.
PMCB give kids, adults and humanity hope and dreams to find cures.
Please watch this wonderful video
https://www.bing.com/videos/search?q=give+kids+the+world+video+make+a+wish&&view=detail&mid=76F4195029D0D7DE6FFE76F4195029D0D7DE6FFE&&FORM=VRDGAR
PMCB: It's Lights Camera Action Time!!!
PMCB is in Action. Austrianova filmed last month to air soon and PMCB is filming as we read this article.
http://austrianova.com/news/news-1/index.html
May 30th 2019: Austrianova’s Head of Production interviewed on Thai TV show
Austrianova’s Head of Production, Rahul Pawa was interviewed on the Thai TV show "Think for the Nation". The TV show interviews prominent local business people who contribute to the Thai society through their work. The interview covered Rahul's career at Austrianova and the company’s activities as well as the importance of the Biotech industry in Thailand and its future. The interview will be broadcasted on Thai national TV in a few weeks.
Also, a film crew will be on hand to document the company’s manufacturing process for the production of a video that will tell PharmaCyte’s pancreatic cancer therapy story in its entirety.
https://pharmacyte.com/pharmacyte-biotech-ceo-in-thailand-to-oversee-production-of-final-clinical-trial-material-for-ind-submission
Thank you $Pistol Pete$' and fellow longs for your positive thoughts!!!
To many people that have been adversely impacted by cancer live daily in constant fears of losing their lives or a loved one.
PMCB and longs on this blog are living the dream to bring positive hope that someday soon reality will turn into cancer cures for those in need.
The Power Of Positive Thoughts:
Like attracts like.
In its simplest form, this means that if you learn to harness the power of positive thoughts, you’ll attract more positive circumstances.
However, if you’re negative, you’ll attract more negativity and pain.
At first glance, you might think this describes Karma but in fact the two concepts are very different.
With Karma, it is believed that if you do “good,” you will be rewarded; if you do “bad,” you will be punished.
With the law of attraction, though, blessings are entirely up to you.
Think positively and you will call positive things to you.
If you have a cynical, insecure, or pessimistic worldview, your negativity will be a self-inflicted, self-fulfilling prophecy.
Like attracts like.
Thank you thenewmixer for confirming the Pre-IND meeting date that appears to be a little over 2 years ago. After further thought it is possible the actual "genuine clinical candidate" status occurred well after the Pre-IND meeting.
PMCB realized that their novel platform IND submission was much much more than a one hitter for pancreas cancer.
Time will tell in retrospect when the novel platform "genuine clinical candidate" status actually occurred.
PMCB's novel platform approved by the FDA would save copious amounts of research time and money for other diseases as well. This would allow for a FDA approved platform with a successful cookie-cutter business model, best practices with operational excellence and next generation health care that would save and/or improve lives.
Can you get onboard with that?
PMCB well within reasonable time period to file IND!
Many first-time applicants greatly underestimate the time that it takes to prepare and submit a well-designed, well-executed IND. From the time you have a genuine clinical candidate, you can typically plan on at least a two-year time frame to gather sufficient information to file an IND and submit it to the FDA.
Seems like PMCB became a genuine clinical candidate at Pre-IND meeting less than 2 years ago. So PMCB is tracking on the correct average time and may even be ahead of schedule!
Cheers to PMCB longs!!!
Preparing for Your First IND Submission: The Devil is in the Details!
Not worried about PMCB timing as long as final documentation helps to prove the science behind their novel platform and achieves the best product as possible for IND process and humanity!!! Ladies and Gentlemen this will happen soon.
Check out this article:Preparing for Your First IND Submission: The Devil is in the Details When preparing an IND submission, an open mind and ability to
Jan 01, 2008 By Conrad J. Heilman, Jr., PhD, Joseph J. Villafranca, PhD BioPharm International Volume 21, Issue 1
Here is the link http://www.biopharminternational.com/preparing-your-first-ind-submission-devil-details?id=&pageID=1&sk=&date=
"In fact, the best way to get the most out of the IND submission process is to see it as a way of helping you produce the best product you possibly can."
"DOCUMENT AS YOU GO
Some first-time applicants wait until very late in the process to begin creating the IND application. You should write up each of the milestones required on the application as you complete them, instead of being forced belatedly to put together what is usually a voluminous document. The documentation will be fresh and you will have time to make sure that it is scientifically sound, addresses a medical need, and has a safety profile appropriate for the clinical indication. If your organization does not have prior experience with writing INDs, hire a professional contractor who understands the types of issues that the FDA often raises. This will be money well spent, because your IND document will be professionally prepared according to FDA expectations."
With Federal Government Awards Patience Is a Virtue That Can Lead to Great Rewards!
“He that can have patience can have what he will.” Benjamin Franklin
“You can have everything in life you want, if you will just help other people get what they want.” – Zig Ziglar
Those who know about doing business with the Federal Government and are awarded contracts, grants and approvals expect delays in time as the rule.
Always add at least 3 months plus to expected due dates with Federal Government deadlines. This game is not for the fainthearted.
The time PMCB is taking to achieve approvals is no exception.
I know because I have won large almost impossible contracts with Federal Government agencies and clearly see the time delay trend built in.
This is an infinite game we are playing for life and death with PMCB. The penny stock naysayers on this board play a finite game for immediate satisfaction, greed and manipulation playing the role of bad actors being the winners and declaring everyone else the losers!
Like others who have played the Federal Government patience infinite time game, PMCB will end up disrupting their industry and stay around a long time solving unmet needs.
Cheers PMCB this is a long term game worthy of playing!!!
Watchful Eye For Medpace Hiring to support PMCB CRO!
This link will take you to Medpace Career site searching for PMCB project hiring.
https://careershub-medpace.icims.com/jobs/search?ss=1&searchKeyword=cro
(Note: I entered "CRO" in career search. There may be other jobs available for project without this search)
Does anyone see any hiring for PMCB CRO skillsets going on yet?
Clinical Trial Manager (Oncology)
https://uscareers-medpace.icims.com/jobs/3953/clinical-trial-manager-%28oncology%29/job?hub=6
PharmaCyte Biotech, Inc. (PMCB), a clinical stage biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box ®, announced today that it has selected Medpace, Inc. as the Contract Research Organization (CRO) to conduct PharmaCyte’s clinical trial in locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC).
https://pharmacyte.com/pharmacyte-biotech-selects-medpace-cro-clinical-trial-pancreatic-cancer
Pmcb owns 14.5% of Austrianova Could Be Revenue Ready?
Does anyone know how current this information is?
Investors
We are currently closing a 3 million USD investment round to fund our further expansion especially into the GMP food grade manufacturing of encapsulated probiotics. If you are interested in more details about this investment opportunity, please email our Investment Advisers: Square Associates (Singapore) info@square-associates.com
http://austrianova.com/who-we-are--encapsulation-gmp-cells--1/investors-encapsulation-gmp-cells-cell-in-a-box.html
The holy grail of value from PMCB is profitable revenues from IND success, investments and protectable patents.
Any idea how real and close revenues from Austrianova Bac-In-Box are?
http://austrianova.com/microencapsulation-bac-in-a-box-bacterial-encapsulation/microencapsulation-bac-in-a-box-bacterial-encapsulation-1/index.html
Dr. Manuel Hidalgo Named Chief of the Division of Hematology and Medical Oncology at Weill Cornell Medicine and NewYork-Presbyterian/Weill Cornell Medical Center
Check this link out for further information.
https://news.weill.cornell.edu/news/2019/03/dr-manuel-hidalgo-named-chief-of-the-division-of-hematology-and-medical-oncology-at
Any connection between this
A respected oncologist and premier investigator, Dr. Hidalgo’s work has centered on translational and clinical research in anticancer drug development with a particular emphasis in gastrointestinal cancers. He has developed, tested and helmed the early clinical development of more than 50 new anticancer agents for pancreatic and other solid tumor cancers. Three of those agents, including nab-paclitaxel, are now approved by the U.S. Food and Drug Administration for treatment of GI cancers, including pancreatic cancer. His team also pioneered the development of a personalized cancer model using mice, called mouse avatars, to pre-test cancer treatments.
“We are delighted that Dr. Hidalgo will be joining Weill Cornell Medicine and NewYork-Presbyterian as the new chief of hematology and medical oncology,” said Dr. Anthony Hollenberg, the Weill Chairman of the Weill Department of Medicine at Weill Cornell Medicine and physician-in-chief at NewYork-Presbyterian/Weill Cornell Medical Center. “He is a gifted clinician, skilled leader and educator, and his innovative research in pancreatic cancer and drug development is unparalleled. He will undoubtedly be instrumental in the institutions' vision to both broaden healthcare access for underserved populations and strive for the ultimate goal of discovering treatments and cures for cancer."
And this?
Given your experience with numerous clinical trials, what were you specifically looking for during the CRO selection process that would complement your work as the Principal Investigator of PharmaCyte’s clinical trial in LAPC?
Dr. Manuel Hidalgo: “A CRO is a critical component in conducting a successful clinical trial, and you really need an excellent one with broad experience in the disease being studied – in this case pancreatic cancer. The most important piece, of course, is to be fully compliant with the regulatory requirements in terms of approvals, reporting and related issues.
“PharmaCyte’s therapy is novel and complex and is addressing an unmet medical need where there is no effective therapy after the first-line therapy no longer provides any further benefit to a patient. So, it’s also critical that the CRO has considerable experience with trials involving pancreatic cancer and the patient population we are targeting and has team members who are experienced with the complexities involved with PharmaCyte’s therapy.
“The role of the CRO monitors is also crucial as the quality of the data largely depends on how well the patients enrolled in the trial are monitored. Finally, I like a CRO to be fully integrated with the sponsor and the investigators and not try to function as an independent entity.”
PMCB IND is Imminent with the Eminent team to make it happen!!!
PMCB Potential To Be More Like Miracle Of Vaccines!
When approved, the script will read "PharmaCyte Cell-in-a-Box® Saves Lives"
Someday PMCB will create an easy to understand animated video like this one
Bill Gates: Vaccines Save Lives | Bill & Melinda Gates Foundation
Great point and research 1234jklm
Kenneth L. Waggoner – Chief Executive Officer, President, General Counsel and Chairman of the Board
Mr. Waggoner more than qualified to protect PMCB to success. See LinkedIn
https://www.linkedin.com/in/kenneth-l-waggoner-08042215
see this 2017 video presentation and notice the "TRUMP" logo on podium.
Precision Promise Will Welcome PMCB Meeting Unmet Needs!
see this video
Dear God, please cure cancer. Amen
Top 20 Pancreatic Cancer Blogs and Websites on the Web
Pancreatic Cancer Blogs List.
The Best Pancreatic Cancer blogs from thousands of top Cancer blogs in our index using search and social metrics. Data will be refreshed once a week.
https://blog.feedspot.com/pancreatic_cancer_blogs
Suggest monitoring these top blogs sites. Perhaps someone can follow and post about PMCB's progress?
Like a deadly fatal cancer some on our blog site talk negatively against PMCB without merit. That's OK for now as there should be freedom of speech. When you and your loved ones are dying from a deadly cancer, we will not hold a grudge and will pray for your/their cures as well.
Soon, very soon PMCB will submit their IND and true real-time transparent positive data and news will rule the day!!!
P.S. Note Researchers ID gene that may predict pancreatic cancer in people with type 2 diabetes.
Any company you know working on both pancreatic cancer and people with diabetes? https://medicalxpress.com/news/2019-02-id-gene-pancreatic-cancer-people.html
Feels like PMCB investors have ran the most extreme non-stop exhausting Iron man race of all races!
Don't give up keep going to finish the race.
All the best to PMCB believers!
PMCB A Diamond In The Rough!
A diamond doesn't start out polished and shining. It once was nothing special, but with enough pressure and time, becomes spectacular.
How long does it take for a diamond to form?
That is miles upon miles between the earth’s surface. Due to the immense pressure that is present in this part of the earth, as well as the extreme temperatures, a diamond gradually begins to form. The entire process takes between 1 billion and 3.3 billion years, which is approximately 25% to 75% of our earth’s age.
PMCB is worth the wait (days not years now) and will shine like a diamond soon!