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Big buys? Where? Hope you're being sarcastic in an effort to lighten things up here!
How do know how many shares are left at what PPS?
FDA
Orphan Products Grants Program
FAQ Concerning the Orphan Products Grants
http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/WhomtoContactaboutOrphanProductDevelopment/ucm224956.htm
Who may apply for an Orphan Product Grant?
Orphan products grants are available to any foreign or domestic, public or private, for-profit or nonprofit entity, including state and local units of government. Federal agencies that are not part of the Department of Health and Human Services may also apply. For-profit entities must commit to excluding fees or profit in their request for support to receive grant awards. Organizations that engage in lobbying activities, as described in section 501(c)(4) of the Internal Revenue Code of 1968, are not eligible to receive grant awards.
What types of products qualify?
Products that qualify for this grant program are drugs, biologics, medical devices, and foods for medical purposes that are indicated (used) for a disease or condition that affects fewer than 200,000 people in the United States. Diagnostics and vaccines will qualify for the program only if the United States population to whom they will be administered is fewer than 200,000 people per year.
Must a product hold orphan drug designation in order to be eligible for the grant program?
A drug or biologic product does NOT have to hold orphan drug designation to be eligible for the grant program. The Background and Significance section of the application must contain information documenting the prevalence, not incidence, of the population to be served by the product is fewer than 200,000 individuals in the United States. The applicant should include a detailed explanation supplemented by authoritative references in support of the prevalence figure. Diagnostic tests and vaccines will qualify only if the population to whom they will be administered is fewer than 200,000 individuals in the United States per year.
The orphan drug designation process is the mechanism by which sponsors of drugs and biologics for rare diseases may qualify for incentives of the Orphan Drug Act such as tax credits and marketing exclusivity. Orphan designation is encouraged especially if the indication is questionable whether it would apply for orphan drug status.
What studies qualify for orphan product grants?
Only clinical studies qualify for consideration. Each application should propose one discrete clinical study designed to facilitate FDA approval of the product for use in a rare disease or condition. The study may address an unapproved new product or an unapproved new use for a product already on the market.
The goal of FDA's OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy. FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products.
How much money is available for orphan product grants?
Of the estimated FY funding ($14.1 million), approximately $10 million will fund noncompeting continuation awards, and approximately $4.1 million will fund 5 to 10 new awards, subject to availability of funds.
Phase 1 studies are eligible for up to $250,000 per year for up to 3 years. Phase 2 and 3 studies are eligible for up to $500,000 per year for up to 4 years. Please note that the dollar limitation will apply to total costs (direct plus indirect). Budgets for each year of requested support may not exceed the $250,000 or $500,000 total cost limit, whichever is applicable.
How are applications reviewed? How are awards made?
FDA grants management and program staff will review all applications. To be responsive, an application must be submitted in accordance with the requirements of the Request for Applications (RFA). Applications found to be non-responsive will be returned to the applicant without further consideration.
Responsive applications will be reviewed and evaluated for scientific and technical merit by an ad hoc panel of experts in the subject field of the specific application. Consultation with the proper FDA review division may also occur during this phase of the review to determine whether the proposed study will provide acceptable data that could contribute to product approval. Responsive applications will be subject to a second review by the National Cancer Institute, National Cancer Advisory Board (NCAB) for concurrence with the recommendations made by the first-level reviewers, and funding decisions will be made by the Commissioner of Food and Drugs or his designee.
A score will be assigned to each application based on the scientific/technical review criteria. The review panel may advise the program staff about the appropriateness of the proposal to the goals of the OPD grant program.
Applications submitted will compete for available funds with all other recommended applications submitted in response to the RFA. The following will be considered in making funding decisions:
Scientific merit of the proposed project as determined by peer review.
Availability of funds.
Relevance of the proposed project to program priorities.
Do I need an Investigational New Drug Application (IND) or an Investigational Device Exemption (IDE) in order to qualify for an OOPD grant?
Yes, an IND/IDE is needed except for medical foods that do not need premarket approval and medical devices that are classified as non-significant risk (NSR). Applicants studying an NSR device should provide a letter in the application from FDA's Center for Devices and Radiological Health indicating the device is an NSR device.
Protocols involving an approved drug that would otherwise be eligible for an exemption from the IND regulations must be conducted under an IND in order to qualify for funding under this program. The proposed clinical protocol should be submitted to the applicable FDA IND/IDE review division a minimum of 30 days before the grant application deadline. Be sure to indicate in the IND cover letter that you are applying for an orphan product grant. In order to qualify for programmatic/scientific review, the study protocol proposed in the grant application must be under an active IND or IDE (i.e., not on clinical hold).
I have an IND/IDE for the product for another use - is this sufficient?
No. The clinical protocol that is being submitted in the grant application must be submitted to the appropriate FDA review division a minimum of 30 days before the grant application deadline.
Can the proposed study include research being performed at foreign sites?
Can all or part of the funding be used to support foreign clinical study sites?
Yes. The grants are available to any foreign or domestic, public or private, for-profit or nonprofit entity (including State and local units of government). Federal agencies that are not part of the Department of Health and Human Services (HHS) may apply. Agencies that are part of HHS may not apply. For-profit entities must commit to excluding fees or profit in their request for support to receive grant awards. Organizations that engage in lobbying activities, as described in section 501(c)(4) of the Internal Revenue Code of 1968, are not eligible to receive grant awards.
Foreign applications must indicate how the proposed project has specific relevance to the mission and objectives of FDA and has the potential for significantly advancing sciences in the United States.
Do I need a Federal Wide Assurance (FWA) for all foreign and domestic study sites?
Yes. All institutions engaged in human subject research financially supported by HHS must file an assurance of protection for human subjects with the Office of Human Research Protections (OHRP) (45 CFR part 46). Applicants are advised to visit the OHRP Web site for guidance on human subject protection issues. Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained.
The requirement to file an assurance applies to both awardee and collaborating performance site institutions. Awardee institutions are automatically considered to be engaged in human subject research whenever they receive a direct HHS award to support such research, even where all activities involving human subjects are carried out by a subcontractor or collaborator. In such cases, the awardee institution bears the responsibility for protecting human subjects under the award.
The awardee institution is also responsible for, among other things, ensuring that all collaborating performance site institutions engaged in the research hold an approved assurance prior to their initiation of the research. No awardee or performance site institution may spend funds on human subject research or enroll subjects without the approved and applicable assurance(s) on file with OHRP. An awardee institution must, therefore, have its own IRB of record and assurance. The IRB of record may be an IRB already being used by one of the performance sites, but it must specifically be registered as the IRB of record with OHRP.
For further information, applicants should review the section on human subjects in the application instructions as posted on the Grants.gov application Web site. The clinical protocol should comply with ICHE6 Good Clinical Practice Consolidated Guidance which sets an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. All human subject research regulated by FDA is also subject to FDA's regulations regarding the protection of human subjects (21 CFR parts 50 and 56). Applicants are encouraged to review the regulations, guidance, and information sheets on human subject protection and good clinical practice available on the Internet at Running Clinical Trials.
Do I need Institutional Review Board (IRB) approval at time of submission of grant application?
IRB approval is not required at the time of the submission of grant application although documentation of IRB approval for the IRB of record must be on file with the FDA grants management office before an award to fund the study will be made.
Should the protocol and informed consent forms be included in the grant application?
The protocol should be submitted in the application as an appendix. Informed consent and assent forms should be provided as an appendix as well. A draft form of the informed consent and assent documents are acceptable.
Who can I contact for questions concerning the budget of my potential grant application?
Questions regarding financial aspects of a proposed application should be addressed to Vieda Hubbard, Office of Acquisitions & Grant Services, 5630 Fishers Lane, (HFA-500), Room 2141, Rockville, MD 20857, 301-827-7177, e-mail: vieda.hubbard@fda.hhs.gov.
Who can I contact for questions regarding the research/clinical protocol sections of my potential grant application?
Scientific and Research questions should be addressed to Katherine Needleman, Office of Orphan Products Development, Food and Drug Administration 10903 New Hampshire Avenue, WO32-5271, Silver Spring, MD 20993-0002, 301-796-8660, e-mail: katherine.needleman@fda.hhs.gov
How and where do I submit my application?
All applications must be submitted electronically through Grants.gov. The applications must be prepared using the SF424 (R&R) application forms along with the SF424 (R&R) Application Guide for this FOA through http://www.grants.gov/applicants/apply_for_grants.
8k out !
Exhibit 10.1
STOCK PURCHASE AGREEMENT
THIS STOCK PURCHASE AGREEMENT ( “Agreement”) is dated as of June 24, 2014, between BIO-MATRIX SCIENTIFIC GROUP, INC ., a Delaware corporation (the “Company”), and Kendall Prince ( referred to as “Investor ”).
WHEREAS, subject to the terms and conditions set forth in this Agreement and pursuant to Section 4(a) (2) of the Securities Act of 1933, as amended (the “Securities Act”), the Company desires to issue and sell to Investor, and Investor desires to purchase from the Company 45,000,000 of the newly issued common stock of the Company (“Shares”).
NOW, THEREFORE, IT IS AGREED AS FOLLOWS:
1. Representations and Warranties:
(a) The Company hereby makes the representations and warranties set forth below to Investors.
(i) Company (a) is a corporation duly formed, validly existing and in good standing under the laws of its State of Incorporation; and (b) has all requisite power and authority, and has all governmental licenses, authorizations, consents and approvals necessary to execute and deliver this Agreement and to consummate the transactions contemplated by this Agreement.
(ii) No Conflicts. None of the execution, delivery and performance of this Agreement by Company, or the consummation of the transactions contemplated hereby and thereby (a) constitutes or will constitute a violation of the organizational documents of Company, (b) constitutes or will constitute a breach or violation of, or a default (or an event which, with notice or lapse of time or both, would constitute such a default) under, any indenture, mortgage, deed of trust, loan agreement, lease or other agreement or instrument to which Company is a party or by which Company or any of its properties may be bound, (c) violates or will violate any statute, law or regulation or any order, judgment, decree or injunction of any court or Governmental Authority directed to Company or any of its properties in a proceeding to which its property is or was a party
(iii) Neither the Company, nor any of its Affiliates, nor any Person acting on its or their behalf, has engaged in any form of general solicitation or general advertising in connection with the offer or sale of the Shares. “Affiliate” shall mean any Person which directly or indirectly through one or more intermediaries controls, or is controlled by or is under common control, with a Person, as such terms are used in and construed under Rule 144 under the Securities Act. The term “control” means the possession, directly or indirectly, of the power to cause the direction of the management and policies of a Person, whether through the ownership of voting securities, by contract or otherwise.
(b) Investor hereby makes the representations and warranties set forth below to the Company:
Investor is an accredited investor as that term is defined in Rule 501 of Regulation D promulgated under the securities Act of 1933, as amended
Investor is not purchasing the Shares as a result of any general solicitation or general advertisement.
Investor is aware that the purchase of the Shares is a speculative investment involving a high degree of risk and that there is no guarantee that the Investor will realize any gain from this investment, and that the Investor could lose the total amount of the Investor's investment.
Investor represents that the Investor has adequate means of providing for his or her current needs and personal and family contingencies and has no need for liquidity in this investment in the Shares. The Investor has no reason to anticipate any material change in his or her personal financial condition for the foreseeable future.
Investor is financially able to bear the economic risk of this investment, including the ability to hold the Shares indefinitely or to afford a complete loss of the Investor’s investment.
Investor represents that Investor's overall commitment to this investment is not disproportionate to the Investor's net worth, and the Investor's investment in the Shares will not cause such overall commitment to become excessive. The Investor will not pledge, transfer, or assign this Agreement.
Investor represents that he has been made aware that the Shares are being issued pursuant to Section 4(a) (2) of the Securities Act of 1933, as amended and shall not be registered under the Securities laws of any State.
Investor agrees that any securities to be issued pursuant to this Agreement shall contain the following or a similar restrictive legend:
THESE SECURITIES HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”), OR SECURITIES LAWS OF ANY STATE AND MAY NOT BE OFFERED, SOLD, ASSIGNED, PLEDGED, TRANSFERRED OR OTHERWISE DISPOSED OF IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT UNDER THE ACT AND APPLICABLE STATE SECURITIES LAWS OR PURSUANT TO AN AVAILABLE EXEMPTION FROM REGISTRATION UNDER THE ACT OR SUCH LAWS AND, IF REQUESTED BY THE COMPANY, UPON DELIVERY OF AN OPINION OF COUNSEL REASONABLY SATISFACTORY TO THE COMPANY THAT THE PROPOSED TRANSFER IS EXEMPT FROM THE ACT OR SUCH LAWS.
Investor (i) has been provided with sufficient information with respect to the business of the Company for the Investor to determine the suitability of making an investment in the Company and such documents relating to the Company as the Investor has requested and the Investor has carefully reviewed the same, (ii) has been provided with such additional information with respect to the Company and its business and financial condition as the Investor, or the Investor’s agent or attorney, has requested, and (iii) has had access to management of the Company and the opportunity to discuss the information provided by management of the Company and any questions that the Investor had with respect thereto have been answered to the full satisfaction of the Investor.
2. Purchase of Shares; Closing.
(a)Upon the terms and subject to the conditions set forth herein, concurrent with the execution and delivery of this Agreement by the parties hereto, the Company agrees to sell, and Investor agrees to purchase 45,000,000 newly issued Common Shares of the Company at .002222 per Common Share for a total of $100,000 (“Subscription Amount”)
(b) Within three (3) business day following execution of this Agreement, the Investor shall deposit by wire transfer the Subscription Amount to the following account:
E*TRADE Clearing
PO Box 484
Jersey City, NJ 07303-0484
ABA transit routing number 056073573
Account number: 6781-2764
Bio-Matrix Scientific Group Inc.
4700 Spring Street, Suite 304
La Mesa, CA 91942
(c) Within 5 days of payment of the Subscription Amount by the Investor, the Company shall deliver to Investor that number of Shares subscribed to by Investor pursuant to this Agreement as per the following instructions:
Name: Kendall Prince
Address: 2526 East Edgewood Avenue
Mesa, AZ 85204
528-21-3078
3. Termination. This Agreement may be terminated at any time prior to the Closing:
(a) By mutual written agreement of the Investor and the Company;
(b) By the Company if the Subscription Amount has not been delivered in accordance with 2(b)
4. Governing Law; Venue; Waiver of Jury Trial. All questions concerning the construction, validity, enforcement and interpretation of this Agreement shall be governed by and construed and enforced in accordance with the internal laws of the State of California, without regard to the principles of conflicts of law thereof. Each party hereby irrevocably submits to the exclusive jurisdiction of the state and federal courts sitting in California for the adjudication of any dispute hereunder or in connection herewith or with any transaction contemplated hereby or discussed herein and hereby irrevocably waives, and agrees not to assert in any suit, action or proceeding, any claim that it is not personally subject to the jurisdiction of any such court, that such suit, action or proceeding is improper or inconvenient venue for such proceeding. If either party shall commence an action or proceeding to enforce any provisions of this Agreement, then the prevailing party in such action or proceeding shall be reimbursed by the other party for its attorneys’ fees and other costs and expenses incurred with the investigation, preparation and prosecution of such action or proceeding.
5. Execution. This Agreement may be executed in two or more counterparts, all of which when taken together shall be considered one and the same agreement and shall become effective when counterparts have been signed by each party and delivered to the other party, it being understood that both parties need not sign the same counterpart. In the event that any signature is delivered by facsimile transmission, such signature shall create a valid and binding obligation of the party executing (or on whose behalf such signature is executed) with the same force and effect as if such facsimile signature page were an original thereof.
6. Severability. If any provision of this Agreement is held to be invalid or unenforceable in any respect, the validity and enforceability of the remaining terms and provisions of this Agreement shall not in any way be affected or impaired thereby and the parties will attempt to agree upon a valid and enforceable provision that is a reasonable substitute therefore, and upon so agreeing, shall incorporate such substitute provision in this Agreement.
7. Entire Agreement. This Agreement constitutes a final written expression of all the terms of the agreement between the parties regarding the subject matter hereof, are a complete and exclusive statement of those terms, and supersedes all prior and contemporaneous agreements, understandings, and representations between the parties.
IN WITNESS WHEREOF, the parties hereto have caused this Stock Purchase Agreement to be duly executed by their respective authorized signatories as of the date first indicated above.
Company
By/s/David R. Koos
David R. Koos
Chairman & CEO
Bio-Matrix Scientific Group Inc.
Investor
By/s/Kendall Prince
Kendall Prince
BMSN$$$$$$$$$$$$$$$BMSN$$$$$$$$$$$$$$$$$$BMSN$$$$$$$$$$$$$$$$$BMSN
Just curious, did you buy/invest in this stock looking for a quick return?
DD suggests the average time for a start up biotech to become successful is _______________. If at all.
IMHO
$$$BMSN$$$BMSN$$$BMSN$$$
Recognition of Rare Disease Day February 28, 2015
February 27, 2015
Rare Diseases at FDA: A Successful Year for Orphan Products
By: Gayatri R. Rao, M.D., J.D.
2014 was a strong year for rare disease product development at FDA. It was also a year of significant firsts.
Dr. Gayatri RaoIn recognition of Rare Disease Day, February 28th, we want to reflect on the progress we have made thus far as we renew our commitment to rare disease patients. A rare disease is generally defined as a disease which affects fewer than 200,000 Americans a year. At FDA, the commitment to increase access to diagnostics and treatments to change the day-to-day reality of those living with rare diseases began over 30 years ago with the passage of the Orphan Drug Act.That commitment has steadily increased since then.
In 2014, we received our highest number to date of new requests for orphan drug designation. We received over 440 requests while just 7 years ago, we received less than half of that. We designated and approved more orphan drugs in 2014 than we had in previous years – nearly 300 drugs were designated and 48 were approved, including both novel and repurposed drugs. In 2014, 41% of all novel new drugs approved by the Center for Drug Evaluation and Research were for the treatment of rare diseases. Many of these orphan drug approvals were new and innovative, including Sylvant, to treat Castleman’s disease, which results in excessive lymph node growth, and Impavido, to treat forms of the tropical disease, leishmaniasis.
2014 was also a year of firsts for rare disease product development:
There were firsts in device development. For example, the Center for Biologics Evaluation and Research approved its first device through the Humanitarian Device Exemption (HDE) pathway. This device, CliniMACS CD34 Reagent System, helps to mitigate potentially serious immune reactions associated with stem cell transplantation in patients with acute myeloid leukemia.
FDA produced in 2014 its first agency-wide blueprint to accelerate the development of therapies for pediatric rare diseases – a report and strategic plan outlining how to address issues for developing products for this population.
2014 saw the issuance of the first rare pediatric disease priority review voucher for the treatment of mucopolysaccharidosis type IVA (Morquio A syndrome), a rare lysosomal storage disease which affects about 1000 patients in the United States and can lead to debilitating and life-threatening abnormalities of bones, joints and the heart.
In recognition of Rare Disease Day 2015, the international rare disease community is coming together to pay tribute to the millions of individuals impacted by rare diseases all over the world. Through the solidarity and commitment of many stakeholders – patients and families, healthcare professionals, researchers, companies, and policy makers – the awareness of the daily challenges that are unique to each rare disease and the efforts to create solutions has risen exponentially in the past several decades. As members of the rare disease community, we are proud of our collective accomplishments but remain acutely aware of how much more there is still to be done. Given how 2015 is already shaping up, we expect that by working together, we will continue to make great strides in developing much needed products for the millions of patients living with rare diseases.
Gayatri R. Rao, M.D., J.D., is FDA’s Director for The Office of Orphan Products Development
http://blogs.fda.gov/fdavoice/index.php/2015/02/rare-diseases-at-fda-a-successful-year-for-orphan-products/
Rare Diseases at FDA: A Successful Year for Orphan Products
Posted on February 27, 2015 by FDA Voice
By: Gayatri R. Rao, M.D., J.D.
2014 was a strong year for rare disease product development at FDA. It was also a year of significant firsts.
Dr. Gayatri RaoIn recognition of Rare Disease Day, February 28th, we want to reflect on the progress we have made thus far as we renew our commitment to rare disease patients. A rare disease is generally defined as a disease which affects fewer than 200,000 Americans a year. At FDA, the commitment to increase access to diagnostics and treatments to change the day-to-day reality of those living with rare diseases began over 30 years ago with the passage of the Orphan Drug Act.That commitment has steadily increased since then.
In 2014, we received our highest number to date of new requests for orphan drug designation. We received over 440 requests while just 7 years ago, we received less than half of that. We designated and approved more orphan drugs in 2014 than we had in previous years – nearly 300 drugs were designated and 48 were approved, including both novel and repurposed drugs. In 2014, 41% of all novel new drugs approved by the Center for Drug Evaluation and Research were for the treatment of rare diseases. Many of these orphan drug approvals were new and innovative, including Sylvant, to treat Castleman’s disease, which results in excessive lymph node growth, and Impavido, to treat forms of the tropical disease, leishmaniasis.
2014 was also a year of firsts for rare disease product development:
There were firsts in device development. For example, the Center for Biologics Evaluation and Research approved its first device through the Humanitarian Device Exemption (HDE) pathway. This device, CliniMACS CD34 Reagent System, helps to mitigate potentially serious immune reactions associated with stem cell transplantation in patients with acute myeloid leukemia.
FDA produced in 2014 its first agency-wide blueprint to accelerate the development of therapies for pediatric rare diseases – a report and strategic plan outlining how to address issues for developing products for this population.
2014 saw the issuance of the first rare pediatric disease priority review voucher for the treatment of mucopolysaccharidosis type IVA (Morquio A syndrome), a rare lysosomal storage disease which affects about 1000 patients in the United States and can lead to debilitating and life-threatening abnormalities of bones, joints and the heart.
In recognition of Rare Disease Day 2015, the international rare disease community is coming together to pay tribute to the millions of individuals impacted by rare diseases all over the world. Through the solidarity and commitment of many stakeholders – patients and families, healthcare professionals, researchers, companies, and policy makers – the awareness of the daily challenges that are unique to each rare disease and the efforts to create solutions has risen exponentially in the past several decades. As members of the rare disease community, we are proud of our collective accomplishments but remain acutely aware of how much more there is still to be done. Given how 2015 is already shaping up, we expect that by working together, we will continue to make great strides in developing much needed products for the millions of patients living with rare diseases.
Gayatri R. Rao, M.D., J.D., is FDA’s Director for The Office of Orphan Products Development
http://blogs.fda.gov/fdavoice/index.php/2015/02/rare-diseases-at-fda-a-successful-year-for-orphan-products/
Everyone have their (long/short term) exit strategies tentatively in place?
BMSN
You can bet this didn't help the FDA's (CBER) turn around time in an already, very slow bureaucratic process.
[Federal Register Volume 79, Number 43 (Wednesday, March 5, 2014)]
[Notices]
[Pages 12506-12507]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04810]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0225]
Announcement of Center for Biologics Evaluation and Research's
Move to the Food and Drug Administration's White Oak Campus
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that the
Center for Biologics Evaluation and Research (CBER) will be moving its
offices and laboratories from various Rockville and Bethesda, MD,
locations to the FDA White Oak campus in Silver Spring, MD. The move
will commence on or about May 1, 2014, and will end approximately 8
weeks later, on or about July 1, 2014. During this time persons may
continue to send applications and other submissions electronically via
the FDA Electronic Submissions Gateway to CBER for review, evaluation,
or other handling. However, persons should send submissions on paper or
on electronic media (CD, DVD), as well as lot release samples to CBER's
new mailing addresses once they take effect. CBER's new mailing
addresses, including the dates they take effect, as well as other
information concerning CBER's move to the FDA White Oak campus in
Silver Spring, MD, will be provided on the FDA Web site at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm, as they become available. During the period
required for relocation of files, equipment, and Agency personnel, CBER
will make every effort to meet its review time frames and minimize any
potential
[[Page 12507]]
delay. Should delays affecting receipt and review of applications and
other submissions occur, we intend to update the FDA Web site as
needed.
FOR FURTHER INFORMATION CONTACT: John Reilly, Center for Biologics
Evaluation and Research (HFM-17), Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 201 et
seq.) and section 351 of the Public Health Service Act (42 U.S.C. 262),
CBER is responsible for receiving, reviewing, evaluating, and taking
appropriate actions on a variety of regulated activities, including but
not limited to:
(1) Investigational new drug applications and investigational
device exemption applications for certain products for which CBER has
been assigned responsibility;
(2) Biologics license applications submitted for biological
products;
(3) New drug applications, abbreviated new drug applications,
premarket approval applications, and premarket notifications for which
CBER has been assigned responsibility; and
(4) Protocols and samples submitted for official release (lot
release).
In an effort to consolidate, FDA is moving CBER's offices and
laboratories from various Rockville and Bethesda, MD, locations to the
FDA White Oak campus in Silver Spring, MD. The move will commence on or
about May 1, 2014, and will end approximately 8 weeks later, on or
about July 1, 2014. During this time, persons may continue to send
applications and other submissions electronically via the FDA
Electronic Submissions Gateway to CBER for review, evaluation, or other
handling. However, persons should send submissions on paper or on
electronic media (CD, DVD) (including lot release protocols) to CBER's
new mailing addresses once they take effect. CBER's new mailing
addresses, including the dates they take effect, as well as other
information concerning CBER's move to the FDA White Oak campus in
Silver Spring, MD, will be provided on the FDA Web site at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm as they become available.
Lot release samples should be sent to the appropriate new mailing
address when it takes effect. Please note, however, that because of the
relocation of CBER's Sample Custodian (the person(s) responsible for
receiving official samples, including lot release samples) to the FDA
White Oak campus, CBER will not be able to receive lot release samples
during the 2 weeks surrounding this personnel move. This pause will
allow us to assure the orderly transfer of lot release samples to the
FDA White Oak campus in the weeks immediately before and after this
move. Therefore, lot release samples should be shipped to CBER either
(1) before the pause, using the current address, or (2) after the
pause, using the new address once it takes effect. See the FDA Web site
at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm for the dates of
this pause. We also plan to communicate directly with those
manufacturers affected by this temporary interruption in CBER's receipt
of lot release samples.
During the period required for relocation of files, equipment, and
Agency personnel, CBER will make every effort to meet its review time
frames and minimize any potential delay. Should delays affecting
receipt and review of applications and other submissions occur, we
intend to update the FDA Web site as needed.
II. Comments
Persons who have questions or wish further information concerning
CBER's move to the FDA White Oak campus in Silver Spring, MD, may
access the FDA Web site at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm for more
information. CBER intends to update this Web site periodically.
Dated: February 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-04810 Filed 3-4-14; 8:45 am]
BILLING CODE 4160-01-P
Interesting article from the FDA's CBER division this morning.
CBER is the Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.
August 12, 2014
Stem cell therapy: FDA regulatory science aims to facilitate development of safe and effective regenerative medicine products
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By: Steve Bauer, Ph.D.
One of FDA’s primary missions is to make sure that the products we approve are safe and effective. There is tremendous interest in the development of regenerative medicine, including numerous proposed products that rely on stem cells. Stem cells have the ability to generate more stem cells or to turn into more mature cell types such as nerve- or bone-producing cells. These properties make stem cells potentially well suited for use in regenerative medicine. They might be used in repairing heart, nerve, and brain damage or in treating diabetes and other diseases by repairing or replacing cells and tissues.
Steve Bauer, Ph.D., chief of the Cellular and Tissues Therapy Branch, Division of Cellular and Gene Therapies, in the Office of Cellular, Tissue and Gene Therapy at CBER.
Because stem cells can change based on their surroundings, whether during growth outside of the body or following injection into the body, ensuring the safety of effective regenerative medicine products can be challenging. One type of adult stem cell, the multipotent marrow stromal cell (MSC) — more popularly called the mesenchymal stem cell — is the subject of a great deal of research in regenerative medicine. These cells can divide repeatedly, making additional cells, and under the right conditions can be turned into a variety of more specialized and mature types of cells. Depending upon the culture conditions, these more specialized cells have the potential to produce cartilage, bone, and fat, and help with control of inflammation and immunity.
MSCs can be obtained from bone marrow and adipose tissue (fat) and can be grown outside of the body to produce the large numbers needed for many proposed clinical trials. Donated MSCs can also suppress the immune system in individuals who receive them, preventing their rejection and allowing cells from one donor to potentially treat many different people, unlike most other cells or tissues.
But there are still scientific questions to answer about MSCs. A particularly important set of questions is how the manufacturing of these cells outside of the body could affect their potential healing properties and their safety. FDA scientists believe that answering these questions will improve the way MSCs are characterized and thereby facilitate the development of products made from MSCs. For this reason, the FDA’s Center for Biologics Evaluation and Research assembled seven of its laboratories into a consortium to develop tests and techniques that will help answer these types of questions as these products move through the development process.
Using bone-marrow-derived MSCs from eight different human donors, the consortium has published scientific articles on the following topics:
Evaluation of the ability of human MSCs to suppress activation of certain types of mouse immune cells in order to reduce variation in MSC immune suppression assays that use T-cells from human donors who might have many different T-cells. The mouse cells come from a genetically modified strain in which all of the mouse immune T-cells are identical.
Creation of a large database of MSC proteins (a total of 7753) that enabled us to demonstrate the large variability among proteins from different MSC samples. This database will enhance our understanding of MSC biology and help define the variability among various MSC samples.
Identification of 84 proteins (14 identified for the first time) on the surface of MSCs that may be useful for tracking these cells as they grow, divide, and differentiate to produce specific tissues.
Development of techniques that enable scientists to quantify the ability of MSCs to multiply and to differentiate into specific cell types.
Identification of specific genes that distinguish aging MSCs grown in cell culture, which could facilitate development of tests that evaluate the quality of MSCs before they are used to treat patients.
These contributions are part of the overall effort of FDA to bring safe and effective stem cell-based therapies to the many patients who could potentially benefit from this type of regenerative medicine.
Steve Bauer, Ph.D., is the chief of the Cellular and Tissues Therapy Branch, Division of Cellular and Gene Therapies, in the Office of Cellular, Tissue and Gene Therapy at FDA’s Center for Biologics Evaluation and Research.
- See more at: http://blogs.fda.gov/fdavoice/index.php/2014/08/stem-cell-therapy-fda-regulatory-science-aims-to-facilitate-development-of-safe-and-effective-regenerative-medicine-products/?source=govdelivery&utm_medium=email&utm_source=govdelivery#sthash.d0p7IL7u.dpuf
My account shows BMSN closing yesterday at .0029 (+16%) on 30.77 m volume.
Curious, where/how did you come up with 1% ? Tia
One of the several free language translation sites ! Your killing us ! ;(
Are all the "investors" posting their dissatisfaction of PR's being released by BMSN at this time, cognizant of the "quiet period" rules a company must adhere to, prior to their upcoming Regen IPO ? If so, you should be able to answer your own questions !
BMSN $$$$$$$$$$$$ BMSN $$$$$$$$
Personally, I do not want to hear any news until after Thursday this week.
If any, only "negative" news would have to be made public before this Friday.
Please reference post #135643
gotinearly Member Level Monday, 06/09/14 11:22:59 AM
Re: zorro81 post# 135643
Post # of 135702
Indeed. Truly an unintentional apophasis. Good luck and good trading. ; )
How is it possible for any of us to truly know (with only L2 to reference) exactly how many shares a mm actually has for sale?
BMSN
On the Pink Sheets and OTCBB, market makers are not required to show their order size and 99% of the time will not do so. Normally, the size will be 5000 shares. This means that the market maker is obligated to buy or sell 5000 shares at the quoted price. They could have 5000 shares or 5 billion shares to buy or sell. http://learn.advfn.com/index.php?title=Level_II
That's what I thought.. LOL. Are all his posts ctrl c, ctrl v ?
Really? Can't find better things to do with your time than post such BS?
Why do you always only post links pertaining to old, played info?
Investopedia Definition of 'Quarter - Q1, Q2, Q3, Q4'
A three-month period on a financial calendar that acts as a basis for the reporting of earnings and the paying of dividends. A quarter refers to one-fourth of a year and is typically expressed as "Q." The four quarters that make up the year are: January, February and March (Q1); April, May and June (Q2); July, August and September (Q3); and October, November and December (Q4). A quarter is often shown with its relevant year, as in Q1 2012 or Q1/12, which represents the first quarter of the year 2012.
Investopedia explains 'Quarter - Q1, Q2, Q3, Q4'
All public companies in the United States must file quarterly reports (known as 10-Qs) with the U.S. Securities and Exchange Commission (SEC). Each 10-Q contains the public company's unaudited financial statements and company operations information for the previous three months (quarter). 10-Qs are required for the first three quarters of the year. Each publicly traded company must also file an annual report, known as a 10-K, which includes all of the quarters.
Companies, investors and analysts use data from different quarters to make comparisons and evaluate trends. For instance, a retailer may compare this year's Q2 sales over last year's Q2 sales, or an analyst may evaluate a firm's earnings by reviewing data from the same quarter over several years.
Do you think today we might try true statements. DD based on real facts, correct spelling, grammar and mathematically correct equations. Accurate timelines and time frames about BMSN. The wasted time mudslinging BS between immature people trying to make themselves feel superior is getting old!!!
Level II can give you unique insight into a stock's price action, but there are also a lot of things that market makers can do to disguise their true intentions.
Think it's based on the previous days closing price..but now I understand your post.
Think it's based on the previous days closing price..but now I understand your post.
Red..-12.5%..check your math!
Unfortunately !!!
From Pump&dumps website:
"3. INCREASED VOLUME BUT STOCK MOVING SIDEWAYS
A quietly trading stock suddenly shows trading volume but the share price is stuck in a tight range. This is a sign that the insiders are not whacking bids but have plenty of stock for sale at the offer. This is the smartest tactic when dumping stock because in this way, unsuspicious investors like the fact that there seems to be support for the stock and yet it hasn't run away giving them the perception that they are not too late to join the party. Always and inevitably, the share price will fall out of bed once the bids stop coming in and the insiders have no choice but to lower their offer. At that point, other investors will also attempt to cut their losses and join the selling.''
Very possible. I just got tired of all the good/positive PR's only to be met with more shares being sold and the pps going lower. I just needed to get out with something (even though it was a small amount) before the nrxt asher scenario happened. Even though they are a/s, 5 billion for financing? what? the country?
After believing in this company since making a nice profit back in August 2011, I had to get out. Though I lost more than 65% of my investment I sold my 250k shares and walked away with a little more than $700. I have put that small amount into another company and it has already grown to over 1300. (in a few days). For the longest time my mindset was that I had lost so much I might as well just stay in. Wrong! I have been in such a better frame of mind not having anything to do with GYST any longer. Not coming here hoping to read some positive/good news, only to be let down once again. I truly believe that I will re coup the money lost to these people in a short period of time. I don't blame anyone but myself. I just wanted to thank everyone here for their positive thinking/reinforcement and great DD while being part of this board. My only regret is that I did'nt get out sooner. Best of luck to all in the future.
Don't know if you saw this yesterday, it was posted by "asilver8". It does give some insight to that particular area,
for what it's worth.
http://www.heemskerk.sr.org/GoldMining/GoldMining.html
Of course the stock itself could not be down 100% but the poor bast@rd that bought it at it's recent highs could be down way more than 100% !!!
Sweet close? A couple thousand dollars is a sweet close?
Could you please post the mathematical equation for that number? lol, tia
Like the update from the CEO's visit???
Thanks. I own quite a few hundred thousand shares (wish I didnt at this point) and follow all the news but had not seen anything. Just wanted to make sure I did not miss something.
Still Waiting!!!!