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I received an email regarding this today.
In connection with the 2021 Annual Meeting of Stockholders of PharmaCyte Biotech, Inc. (“PharmaCyte”), beginning on or about May 5, 2021, a Notice Regarding Availability of Proxy Materials (“Notice”) was mailed to all stockholders of record as of April 19, 2021. The Annual Meeting of Stockholders will be held virtually at https://www.virtualshareholdermeeting.com/PMCB2021 on Wednesday, June 16, 2021 at 11:00 a.m., Pacific Daylight Time, to consider and vote on the following matters:
1. To elect seven directors as nominated by the Board of Directors of PharmaCyte (“Board”), each to serve a one-year term;
2. To approve a Certificate of Amendment to PharmaCyte’s Articles of Incorporation to increase the number of our authorized shares of common stock;
3. To approve PharmaCyte’s 2021 Equity Incentive Plan; and
4. To ratify PharmaCyte’s appointment of Armanino LLP as PharmaCyte’s independent registered public accounting firm for the fiscal year ending April 30, 2022.
All stockholders will have the ability to access the proxy materials and our Annual Report on Form 10-K for the fiscal year ended April 30, 2020, as amended, on a website referred to in the Notice or to request to receive a printed set of the proxy materials and the Annual Report. The Notice of Annual Meeting and Proxy Statement is filed as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
99.1 Notice of Annual Meeting of Stockholders and Proxy Statement.
https://ir.pharmacyte.com/all-sec-filings/content/0001683168-21-001793/pharmacyte_8k.htm
Today's action caught many, "off-guard" today. Huge volume, over 69,000,000 shares traded today, amazing volume. Someone knows something indeed!
If not approved, we will see a press release at the close of trading tomorrow. Bad news always comes out on a Friday after the market is closed.
If no news tomorrow, next week will be exciting.
My thoughts here.
1) FDA approval tomorrow.
2) No FDA approval will be issued after the market close tomorrow.
3) If no news tomorrow, next week will be great.
OK, thanks so much for sharing this most important insider information with us. So much appreciated!
Same here!
Yep, it's a coming!
Sweating time!
“So far, we have had 5 opportunities to answer the FDA’s questions by supplying the regulatory agency with further clarification and supporting documentation, and we’re pleased with the process to date.”
https://ir.pharmacyte.com/press-releases/detail/256
PharmaCyte Biotech Continues to Engage the FDA During 30-Day Comment Period
September 23, 2020
LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical-stage biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced today that it continues to engage with the U.S. Food and Drug Administration (FDA) during its 30-day comment period regarding the company’s submitted Investigational New Drug application (IND).
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the interactions with the FDA, “We anticipated a number of engagements with the FDA to supplement key information related to our complex treatment. We are advancing a biologic, which is far more complex than developing a single-molecule drug. To our knowledge, the FDA has never had to assess a live-cell encapsulation technology such as ours. The FDA is fully engaged as it assesses the need for our product candidate to be safe and to comply with every cGMP regulation and FDA guidance.
“So far, we have had 5 opportunities to answer the FDA’s questions by supplying the regulatory agency with further clarification and supporting documentation, and we’re pleased with the process to date.”
Once PharmaCyte (the sponsor) submitted its IND, the sponsor must wait 30 calendar days before initiating any clinical trial. During this time, the FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk.
To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: https://www.PharmaCyte.com/Cancer
https://ir.pharmacyte.com/press-releases/detail/256
10-Q: Quarterly report pursuant to Section 13 or 15(d)
From the 10Q out just now:
Stockholders' equity:
Common stock, authorized: 2,490,000,000 shares, $0.0001 par value; 1,875,143,738 and 1,638,637,839 shares issued and outstanding as of July 31, 2020 and April 30, 2020, respectively
Total Liabilities and Stockholders' Equity $7,432,125
https://ir.pharmacyte.com/all-sec-filings/content/0001683168-20-003111/pharmacyte_10q-073120.htm
PharmaCyte Biotech Successfully Completes Second Container Closure Integrity Test
September 08, 2020
LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical-stage biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced today that it has successfully completed the second Container Closure Integrity (CCI) test that is required by the U.S. Food and Drug Administration (FDA) for its CypCaps™ product. This is the second FDA-required test on the product that will be used in the company’s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the completed test, “We are pleased to announce our Cell-in-a-Box® encapsulated cell product CypCaps™ has passed the second CCI test. This test is a component of the 24-month stability study of our CypCaps™. As we explained previously, the CCI test is part of the ongoing study to determine the shelf life of the CypCaps™ final product that the FDA requires for all medical products. The data from the second CCI test will be submitted to the FDA to be included in our recently submitted Investigational New Drug Application (IND).”
Regulatory agencies around the world, including the FDA, require a shelf-life determination for all medical products. Living products, like cell therapies such as CypCaps™, are particularly sensitive and more prone to inactivation over time. Accordingly, it is especially important to determine the shelf-life for PharmaCyte’s clinical trial product.
The FDA specifically required a CCI test be run on PharmaCyte’s clinical trial product and that the data from the CCI test be included in an ongoing basis in PharmaCyte’s IND.
More can be read about the specifics of the CCI test in PharmaCyte’s June 15, 2020 press release: https://pharmacyte.com/pharmacyte-biotech-successfully-accelerates-development-of-container-closure-integrity-test-for-pancreatic-cancer-clinical-trial-product/
To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: https://www.PharmaCyte.com/Cancer
About PharmaCyte Biotech
PharmaCyte Biotech, Inc. (PharmaCyte) is a biotechnology company developing cellular therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” This technology will be used as a platform upon which therapies for several types of cancer and diabetes are being developed.
PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. For pancreatic cancer, these encapsulated cells are implanted in the blood supply to the patient’s tumor as close as possible to the site of the tumor. Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide flows through pores in the capsules, the live cells inside act as a “bio-artificial liver” and activate the chemotherapy drug at the site of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and results in little to no treatment related side effects.
PharmaCyte’s therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes involves encapsulating a human liver cell line that has been genetically engineered to produce and release insulin in response to the levels of blood sugar in the human body. PharmaCyte is also considering the use of genetically modified stem cells to treat diabetes. The encapsulation whatever cell line shows the most promise will be done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient, we anticipate that they will function as a “bio-artificial pancreas” for purposes of insulin production.
Safe Harbor
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that express the current beliefs and expectations of the management of PharmaCyte, including the timing and commencement of our planned Phase 2b clinical trial in LAPC, which is subject to IND approval. Any statements contained herein that do not describe historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results, performance and achievements to differ materially from those discussed in such forward-looking statements. Factors that could affect our actual results include our ability to raise the necessary capital to fund our operations and to find partners to supplement our capabilities and resources, our ability to submit and get approved our pending IND, as well as such other factors that are included in the periodic reports on Form 10-K and Form 10-Q that we file with the U.S. Securities and Exchange Commission. These forward- looking statements are made only as of the date hereof, and we undertake no obligation to update or revise the forward-looking statements, except as otherwise required by law, whether as a result of new information, future events or otherwise.
More information about PharmaCyte Biotech can be found at www.PharmaCyte.com. Information may also be obtained by contacting PharmaCyte’s Investor Relations Department.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200908005408/en/
Dr. Gerald W. Crabtree
Investor Relations:
PharmaCyte Biotech, Inc.
Investor Relations Department
Telephone: 917.595.2856
Email: Info@PharmaCyte.com
Source: PharmaCyte Biotech, Inc.
https://ir.pharmacyte.com/press-releases/detail/254
Released September 8, 2020
Wow, Great post!
'1234jklm', I see now what is occurring here. Double standards indeed!
A2Z, No comment! EOM
Another well stated post!
Well stated post!
Nope no penny, but I purchased an additional 100,000 shares @ $0.0106.
It's coming soon!
FDA Formally Accepts PharmaCyte Biotech’s Drug Master File for Company’s Pancreatic Cancer Therapy
https://ir.pharmacyte.com/press-releases/detail/251
August 05, 2020
LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced today that the Drug Master File (DMF) that its partner, Austrianova, filed with the U.S. Food and Drug Administration (FDA) has been accepted without any questions or suggested changes.
The FDA’s Center for Biologics Evaluation and Research (CBER) successfully processed PharmaCyte’s DMF, which provides all confidential and detailed information covering the production of the CypCaps™ final product that was produced by Austrianova and will be used in PharmaCyte’s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, “CBER’s acceptance and processing of our Drug Master File without any questions or comments is a credit to the painstaking work and dedication by Austrianova and our consultants to ensuring that the entire process is properly conducted and completed before any further documents are submitted to the FDA.
“We now look forward to presenting the FDA with our Investigational New Drug Application very soon for our planned clinical trial in locally advanced, inoperable pancreatic cancer.”
A DMF is submitted to the FDA to provide detailed information about facilities, processes and materials used in the manufacturing, processing and packaging of human drugs. It is a prerequisite to securing approval and commercialization and ensures confidentiality of proprietary information related to the Active Pharmaceutical Ingredient (API). The information contained in a DMF is used to support, among other things, an IND.
The DMF requirements are complex and specific, encompassing every detail involved with the manufacture of the API – from raw materials to analytical methods, process development and optimization. The scrutiny goes all the way back to the starting materials used in the API.
To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: https://www.PharmaCyte.com/Cancer
About PharmaCyte Biotech
PharmaCyte Biotech, Inc. (PharmaCyte) is a biotechnology company developing cellular therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” This technology will be used as a platform upon which therapies for several types of cancer and diabetes are being developed.
PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. For pancreatic cancer, these encapsulated cells are implanted in the blood supply to the patient’s tumor as close as possible to the site of the tumor. Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide flows through pores in the capsules, the live cells inside act as a “bio-artificial liver” and activate the chemotherapy drug at the site of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and results in little to no treatment related side effects.
PharmaCyte’s therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes involves encapsulating a human liver cell line that has been genetically engineered to produce and release insulin in response to the levels of blood sugar in the human body. PharmaCyte is also considering the use of genetically modified stem cells, as well as beta islet cells, to treat diabetes. The encapsulation whatever cell line shows the most promise will be done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient, we anticipate that they will function as a “bio-artificial pancreas” for purposes of insulin production.
Safe Harbor
This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," "outlook" and similar expressions. Forward-looking statements are based on management's current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement because of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements due to the impact of numerous risk factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the Securities and Exchange Commission.
More information about PharmaCyte Biotech can be found at www.PharmaCyte.com. Information may also be obtained by contacting PharmaCyte’s Investor Relations Department.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200805005379/en/
Dr. Gerald W. Crabtree
Investor Relations:
PharmaCyte Biotech, Inc.
Investor Relations Department
Telephone: 917.595.2856
Email: Info@PharmaCyte.com
Source: PharmaCyte Biotech, Inc.
Released August 5, 2020
'$Pistol Pete$', No one can be certain at this juncture if the IND will be rejected by the FDA. The FDA will decide this most important decision in due time.
'Babubd', Agree!
Not a scam. It's a WINNER!
This will rise from here. The news today was GREAT. I'm anxious to see who the CMO will be. If it's someone well known from a large pharma, this will virtually explode to the upside.
Go PMCB
'livendi', well stated post!
'1234jklm', Yep, others were buying besides myself. They may be in the know, we will see soon.
'longboarder7892', Thanks for your informative post.
I've been long this stock for many years. I have not sold a single share. Yesterday and today I purchased and additional 500,000 shares to my existing position on the dip.
In due time this company will be the greatest known company of the OTC land. Go PMCB!
Agree, it was great to see this filing.
Statement of Beneficial Ownership (sc 13d)
May 06 2020 - 02:19PM
Edgar (US Regulatory)
AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
95,262,015(2)
PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)
5.8%(2)
(1) Nima Montazeri is the President of Silver Rock Associates, Inc., and the General Partner of Brown Stone Capital, LP.
(2) Includes 65,262,015 shares of common stock owned by Silver Rock Associates, Inc., and 30,000,000 shares of common stock owned by Brown Stone Capital, LP.
https://ir.pharmacyte.com/all-sec-filings/content/0001753926-20-000100/g081968_sch13d.htm
PharmaCyte Biotech Enters into License Agreement for COVID-19 Diagnostic Kits
April 08, 2020
LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced today that it entered into a License Agreement (Agreement) with Hai Kang Life Corporation Limited, a corporation organized under the laws of Hong Kong (Hai Kang), pursuant to which Hai Kang granted to PharmaCyte a license to certain technology owned or controlled by Hai Kang related to COVID-19 diagnostic kits (Kits). Pursuant to the Agreement, PharmaCyte may directly (or through a third party) conduct research, use, develop, market, sell, distribute, import and export Products for human and veterinary uses in North America, the United Kingdom and certain other European cites (Territory). A “Product” is defined as any existing Kit of Hai Kang or any future Kit derived from Hai Kang’s Kits and includes an in vitro diagnostic test that is designed, manufactured and used within a single laboratory for which the U.S. FDA is not enforcing any premarket review or other regulatory approval requirements.
PharmaCyte is required to use commercially reasonable efforts to develop and commercialize at least one Product in the Territory. This obligation to develop and commercialize a Product includes, among other things, the performance of non-clinical and clinical studies of any Product, the preparation, filing and prosecution of certain regulatory approvals for such Product (including to allow PharmaCyte to market and sell the Product and to get the Product approved for reimbursement). Hai Kang is responsible for all aspects of the manufacture and supply of the Products to be developed and sold under the Agreement.
During the term of the Agreement, PharmaCyte is required to pay a monthly fee to Hai Kang in the amount of $6,000; this monthly fee increases to $50,000 once the first Product receives regulatory approval from the U.S. FDA. In addition, upon the first commercial sale of a Product, PharmaCyte is required to make quarterly royalty payments equal to 10% of Net Sales (as defined in the Agreement) of any Product sold pursuant to the Agreement.
This Agreement has a perpetual term but may be terminated: (i) unilaterally by PharmaCyte with 120 days prior written notice; (ii) in the event one party believes the other party to be in breach of the Agreement by the non-breaching party if the breaching party does not cure the breach within 60 days after the date the breaching party was given notice of such breach; or (iii) by PharmaCyte with the prior written consent of Hai Kang (acting in its sole discretion), but such consent is not to be withheld or delayed if PharmaCyte wishes to terminate on account of demonstrable safety or efficacy concerns in respect of the Product. The Agreement also provides for indemnification by Hai Kang and PharmaCyte under certain circumstances set forth in the Agreement. PharmaCyte may not sell a competing COVID-19 diagnostic kit during the term of the Agreement.
PharmaCyte believes it will need to engage a partner to be able to do the testing necessary to validate the claims made by Hai Kang regarding the sensitivity and specificity of the technology covered by the Agreement, and the technology’s potential clinical utility.
Due to the early stage of both this relationship and the licensed technology, PharmaCyte cannot assure that it will be able to successfully: (i) develop such a Product with PharmaCyte’s current resources, on a timely basis, or at all; (ii) obtain the necessary regulatory approvals for such a Product; (iii) commercialize any such Product; and (iv) get such Product approved for reimbursement in the U.S. and elsewhere. In addition, while Hai Kang is obligated to manufacture any such Product, PharmaCyte cannot assure that the Hai Kang’s manufacture of any Products will comply with U.S. regulatory requirements or that any health care facility or provider will be willing or able to use Products manufactured by Hai Kang.
About PharmaCyte Biotech
PharmaCyte Biotech, Inc. (PharmaCyte) is a biotechnology company developing cellular therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” This technology will be used as a platform upon which therapies for several types of cancer and diabetes are being developed.
PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. For pancreatic cancer, these encapsulated cells are implanted in the blood supply to the patient’s tumor as close as possible to the site of the tumor. Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide flows through pores in the capsules, the live cells inside act as a “bio-artificial liver” and activate the chemotherapy drug at the site of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and results in little to no treatment related side effects.
PharmaCyte’s therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes involves encapsulating a human cell line that has been genetically engineered to produce and release insulin in response to the levels of blood sugar in the human body. PharmaCyte is developing the use of genetically modified liver cells and stem cells, as well as beta islet cells, to treat diabetes. The encapsulation will be done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient, they will function as a “bio-artificial pancreas” for purposes of insulin production.
Safe Harbor
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that express the current beliefs and expectations of the management of PharmaCyte, including statements regarding the viability of the technology that is the subject to the Hai Kang Agreement, our ability to gain the necessary approvals to market and commercialize Products under the Agreement, and the timing and commencement of our first Phase 2b clinical trial. Any statements contained herein that do not describe historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results, performance and achievements to differ materially from those discussed in such forward-looking statements. Factors that could affect our actual results include our ability to raise the necessary capital to fund our operations and to find partners to supplement our capabilities and resources, as well as such other factors that are included in the periodic reports on Form 10-K and Form 10-Q that we file with the U.S. Securities and Exchange Commission. These forward-looking statements are made only as of the date hereof, and we undertake no obligation to update or revise the forward-looking statements, except as otherwise required by law, whether as a result of new information, future events or otherwise.
More information about PharmaCyte can be found at www.PharmaCyte.com. Information may also be obtained by contacting PharmaCyte’s Investor Relations Department.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200408005213/en/
Dr. Gerald W. Crabtree
Investor Relations:
PharmaCyte Biotech, Inc.
Investor Relations Department
Telephone: 917.595.2856
Email: Info@PharmaCyte.com
Source: PharmaCyte Biotech, Inc.
Released April 8, 2020
https://ir.pharmacyte.com/press-releases/detail/231
From Facebook -
Austrianova
22 hrs ·
Austrianova is excited to report that we have just signed a contract for the use of Cell-in-a-Box for hemophilia treatment.
I missed this one on January 6, 2020. Be sure to watch the video too!
PharmaCyte Biotech Exploits Potential Of Its Cell-in-a-Box(R) Technology; Targets Billion Dollar Cancer, Diabetes, and Medicinal Cannabinoid Markets
Newsfile Corp.
NewsfileFebruary 6, 2020
https://finance.yahoo.com/news/pharmacyte-biotech-exploits-potential-cell-133800719.html
Yep, exciting times coming for our PMCB. It's great to be part of this new treatment for pancreatic and other cancers.
Looks like a full house will be there as well at the TVM Capital Healthcare conference. Refer below from the website:
"Sorry, we are at full capacity for this conference and cannot take additional applications and confirmations for attendance"!
https://www.tvmcapitalhealthcare.com/2020-tvm-capital-healthcare-investors-conference/?fbclid=IwAR0xej7AwIa2GPa-F16DjRzFDZvIVAQM7tjJNcwGTSz6bWTmJrHsnmAer_s
Austrianova from Facebook a while ago
1 hr · 2-6-20
Walter H Gunzburg will represent Austrianova as an invited participant at the upcoming TVM Capital Healthcare Investors Conference on 12th February, 2020.
https://www.tvmcapitalhealthcare.com/2020-tvm-capital-healthcare-investors-conference/?fbclid=IwAR0xej7AwIa2GPa-F16DjRzFDZvIVAQM7tjJNcwGTSz6bWTmJrHsnmAer_s
'1234jklm', Great common sense questions. Exciting time coming for PMCB.
It's getting very close. Exciting time for PMCB. Pleased to be part of it too.
'1234jklm', one of the best posts I've seen posted here for a while!
It just keeps slowly going up. I'm so glad I did not sell in the lower 3's.
Go PMCB
FYI on PMCB's Facebook page posted a while ago this evening, refer below:
Pharmacyte Biotech Investors/Shareholders (PMCB)
41 mins ·
PharmaCyte therapy for pancreas cancer is already protected.
PharmaCyte’s pancreas cancer therapy was designated an orphan drug and listed in the official registry of medicinal products for rare diseases by the U.S. Food and Drug Administration (FDA) on December 17, 2014. This orphan drug status assures marketing exclusivity for PharmaCyte’s pancreas cancer therapy in the U.S. for 7 years after market approval by the FDA. Similarly, PharmaCyte has orphan drug status in the European Union (EU) for its pancreas cancer therapy. This designation provides 10 years of marketing exclusivity in all countries in the EU following approval by the European Medicines Agency (EMA).
In addition, the Biologics Price Competition and Innovation Act (BPCIA), which was enacted as part of the Affordable Care Act in 2010, establishes a period of 12 years of “data exclusivity” for reference products to preserve incentives for future innovation. Under this framework, data exclusivity protects the data in the innovator’s regulatory application by prohibiting others, for a period of 12 years, from gaining FDA approval based in part on reliance on or reference to the innovator’s data in a biosimilar application. PharmaCyte’s 12-year exclusivity will begin as soon as the FDA approves the company’s pancreas cancer therapy.
Mr. Waggoner concluded by stating, “While this patent application should make our investors feel assured about the protection of our pancreas cancer therapy, they should understand that if our pancreas cancer therapy receives FDA approval, the orphan drug designation in the U.S. and the EU, together with the BPCIA data exclusivity, will give us substantial marketing exclusivity for our pancreas cancer therapy. This new patent application, while it does include our pancreas cancer therapy, should really be viewed as an opportunity to dramatically broaden PharmaCyte’s ability to protect our therapy for all malignant tumors for the next 20 years.”
https://markets.businessinsider.com/news/stocks/pharmacyte-biotech-strengthens-protection-of-cancer-therapy-with-patent-filing-1002322186