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Asthma Drug Montelukast Tested as Alzheimer’s Treatment in Proof-of-concept Trial
https://alzheimersnewstoday.com/2018/01/29/asthma-drug-montelukast-tested-as-alzheimers-treatment-in-proof-of-concept-trial/
Dr. Isa Odidi, becomes the first Nigerian and African to setup a pharmaceuticals manufacturing plant in China Read more:
https://www.naija.ng/1147400-dr-isa-odidi-nigerian-african-setup-a-pharmaceuticals-manufacturing-plant-china.html#1147400
..did not attend!!
Why? Because they are stupid?
ADMINISTRATIVE PROCEEDINGS RULINGS
Release No. 2430/March 17, 2015
ADMINISTRATIVE PROCEEDING
File No. 3-16393
In the Matter of
CALYPTE BIOMEDICAL CORPORATION,
EC DEVELOPMENT, INC., AND
INFORMATION ARCHITECTS CORPORATION
(N/K/A DAKOTA CREATIVE GROUP
CORPORATION)
ORDER RESCHEDULING
PREHEARING CONFERENCE
On February 20, 2015, the Securities and Exchange Commission (Commission) issued an
Order Instituting Proceedings pursuant to Section 12(j) of the Securities Exchange Act of 1934
against Respondents. A prehearing conference is scheduled for March 24, 2015.
Due to unforeseen circumstances, it is ORDERED that the March 24, 2015, prehearing
conference be rescheduled to April 2, 2015, at 2:00 p.m. EDT. If Respondents fail to attend this
prehearing conference, they will be deemed in default, the proceeding will be determined against
them, and the registrations of their securities will be revoked. See OIP at 3; 17 C.F.R. §
155(a)(2), .220(f).
________________________
Cameron Elliot
Administrative Law Judge
http://www.sec.gov/alj/aljorders/2015/ap-2430.pdf
Growing Preference for Minimally Invasive Surgery
nice...
San Jose, California (PRWEB) March 20, 2015
http://www.prweb.com/releases/ablation_devices_market/microwave_ablation_device/prweb12598263.htm
EDAP recruited in Korea
http://www.saramin.co.kr/zf_user/recruit/recruit-view?idx=22340580
First Clinical Experience of Intra-Operative High Intensity Focused Ultrasound in Patients with Colorectal Liver Metastases: A Phase I-IIa Study
Published: February 26, 2015
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0118212
In the Matter of CALYPTE BIOMEDICAL..
http://www.sec.gov/alj/aljorders/2015/ap-2334.pdf
Guerbet partners HECAM project
insert-text-here
12.02.2015 18:02
The HECAM(1) project is a €41 million research and development competitiveness project, financed to the tune of €18.2 million as part of the future investments program(2). Its ambition is to develop detection, diagnosis and treatment tools for hepatocellular carcinoma (HCC), in other words primary liver cancer.
Originally an idea of Claire Corot (Guerbet’s Research & Innovation and Business Development Licensing Director and member of the board of directors of Medicen), the HCC multi-technological approach project was structured by GE Healthcare. Piloted by GE Healthcare, HECAM comprises Guerbet, seven SMEs(3) and three academic partners(4). They provide and develop first-rate scientific and technical competencies within the project.
The benefit of a collaborative approach for a disease with major health consequences such as HCC is huge. And France has excellent academic, structured research, particularly in the field of medical imaging, paving the way for the emergence of innovative solutions.
Click here to read the press release (only in french).
(1) HEpatocellular CArcinoma Multi-technological.
(2) The program is piloted by the French General Investment Commission (CGI) and operated by Bpifrance. Bpifrance, a subsidiary of the Caisse des Dépôts et de l’État, provides loans, guarantees and capital to companies, from their startup to flotation on the stock market.
(3) BioPredictive, CarThera and IntegraGen (Greater Paris Region), BioSIMS Technologies (Upper Normandy), Intrasense (Languedoc-Roussillon), EDAP TMS France and Fluoptics (Rhône-Alpes).
(4) Gustave Roussy, Europe’s leading cancer treatment center, the Paris Public Hospitals Group (with four hospitals: Beaujon, Jean Verdier, Henri Mondor and Paul Brousse) and the French Healthcare and Medical Research Institute (five INSERM units). The consortium is also supported by the Montpellier Regional University Hospital.
Roth Capital and Credit Suisse Price Target Raised to $8.00
http://www.i3investor.com/servlets/fdnews/163538.jsp
Stock analysts at Roth Capital lifted their price objective on shares of XOMA Corp. (NASDAQ:XOMA) from $6.00 to $8.00 in a report issued on Friday, AnalystRatingsNetwork.com reports. The firm currently has a “buy” rating on the stock. Roth Capital’s target price would indicate a potential upside of 90.02% from the company’s current price.
http://www.i3investor.com/servlets/fdnews/163537.jsp
Investment analysts at Credit Suisse lifted their price objective on shares of XOMA Corp. (NASDAQ:XOMA) from $5.00 to $8.00 in a note issued to investors on Friday, StockRatingsNetwork.com reports. The firm currently has an “outperform” rating on the stock. Credit Suisse’s target price points to a potential upside of 90.02% from the company’s current price.
A number of other firms have also recently commented on XOMA. Analysts at RBC Capital raised their price target on shares of XOMA Corp. from $7.00 to $9.00 in a research note to investors on Thursday. They now have an “outperform” rating on the stock. Separately, analysts at MLV Capital raised their price target on shares of XOMA Corp. from $7.50 to $8.00 in a research note to investors on Thursday. They now have a “buy” rating on the stock. Finally, analysts at Piper Jaffray Cos. initiated coverage on shares of XOMA Corp. in a research note to investors on Monday, August 12th. They set an “overweight” rating and a $8.00 price target on the stock. Seven investment analysts have rated the stock with a buy rating, The stock presently has an average rating of “Buy” and an average price target of $7.63.
Self-Testing Improves HIV Screening...
http://www.idse.net/ViewArticle.aspx?d=HIV-AIDS%2B%2F%2BSTIs&d_id=214&i=April+2013&i_id=947&a_id=23039
About 20% of individuals living with HIV in the United States do not seek testing, and that rate is closer to 60% in resource-limited settings, according to the Centers for Disease Control and Prevention. To address this disparity, alternative methods are needed to improve screening rates.
“Ideally, we want everyone at risk for HIV to be tested once a year, especially people living in resource-constrained settings where testing may be less accessible,” said Elizabeth Corbett, MD, professor of tropical epidemiology, Department of Clinical Research, London School of Hygiene and Tropical Medicine. “HIV self-testing has a lot of potential to fill this gap.”
Several countries, including the United States and Kenya, have approved the sale of over-the-counter HIV self-test kits, such as OraQuick (OraSure Technologies) and Calypte Aware (Calypte Biomedical Corporation). These kits require users to submit an oral sample and include a confidential phone number to help interpret results as well as to provide disease counseling. But other regions, such as the United Kingdom and Canada, remain skeptical about this approach due to limited feasibility data on patient testing behaviors and concerns about access to counseling and care following at-home testing.
To better understand the pros and cons of HIV self-testing, investigators conducted a systematic literature review that explored whether supervised and unsupervised testing increased screening rates, promoted earlier treatment initiation, reduced disease transmission, and if these strategies could be safely and inexpensively implemented worldwide (PLoS Med 2013;10:e1001414).
...................
Yes, with a little help it could got up to 0,2
Yes, we should start a revival.
Calypte -Board of Directors
a small change in the homepage (instead of "coming soon!!")
http://www.calypte.com/boardofdir.html
8-K for CALYPTE BIOMEDICAL CORP
http://biz.yahoo.com/e/130103/cbmc8-k.html
Item 1.01 Entry into a Material Definitive Agreement
On December 27, 2012, Calypte Biomedical Corporation (the “Company”) entered into employment agreements with Adel Karas, its President and Chief Executive Officer and a member of its Board of Directors, and Kartlos Edilashvili, its Chief Financial Officer and a member of its Board of Directors, each effective on January 1, 2013.
The agreement with Mr. Karas provides that he will be employed as President and Chief Executive Officer, based in Dubai, United Arab Emirates, reporting to the Board of Directors. The agreement requires Mr. Karas to devote substantially all reasonable and necessary time, efforts, skills and attention for the benefit of and with his primary attention to the affairs of the Company.
Under his agreement, Mr. Karas is entitled to a base salary of $90,000 per year, increased to $180,000 at such time as the Company achieves profitability. In the event Mr. Karas’s employment is terminated by the Company other than for Cause or by Mr. Karas for Good Reason (each as defined in the agreement), he will be entitled to one year of salary continuation. The agreement further provides that any option grants or similar equity compensation shall provide for six months’ acceleration of vesting in the event Mr. Karas’s employment is terminated by the Company other than for Cause or by Mr. Karas for Good Reason. Under the Agreement, “Cause” is defined as any type of wrongful act by the employee specified in the agreement, including willful failure to perform his duties, dishonest or illegal conduct that materially harms the Company, conviction of certain types of crimes, or material breach of a written agreement with the Company or a written policy established by the Company; “Good Reason” is defined as any type of adverse condition of employment specified in the agreement, including a material reduction in salary, a material adverse change in title, authority, duties or responsibilities, or a relocation of the principal place of employment by more than 100 miles.
Mr. Karas’s agreement prohibits him from competing with the Company during his employment and for a period of 12 months thereafter in the event of his termination for Cause or six months thereafter in all other events. The agreement also contains certain non-solicitation provisions that remain in effect until 12 months following the termination of Mr. Karas’s employment. During such period, Mr. Karas may not take any action to (i) solicit, hire or recruit any employee of the Company, or induce the termination of employment of any such employee or (ii) solicit, contact or meet with the Company’s current, former or prospective customers for the purpose of offering or accepting goods or services similar to or competitive with those offered by the Company.
Mr. Edilashvili’s agreement is substantially identical to Mr. Karas’s, except as follows: (i) Mr. Edilashvili is employed as Chief Financial Officer reporting to the Chief Executive Officer; (ii) his initial base salary is $50,000, increasing to $100,000 when the Company achieves profitability; and (iii) he will be entitled to six months of salary continuation in the event his employment is terminated by the Company other than for Cause or by Mr. Edilashvili for Good Reason.
please try again..
http://biz.yahoo.com/e/121231/cbmc10-q.html
tschuess!
calypte has updated their homepage
http://www.calypte.com/Home.html
Detection of HIV antibodies in oral mucosal transudate: using Calypte Aware HIV 1/2 Test Kit
http://www.amazon.de/gp/aw/d/3846581143/ref=aw_d_detail?pd=1&qid=1354039459
hacked? no, i think soon we will see a new hompage from calypte with some updates and new link's. at least I hope so.
New Biopharma site
http://biopharmafze.com/magento/
Calypte Hompage
http://www.calypte.com/cgi-sys/suspendedpage.cgi
**This hosting account is down for maintenance.**
Good News ahead??
Calypte Biomedical corporation,USA
In the fight against disease, knowledge is power for individuals, communities and nations. To help in the battle, Biopharma FZE distributes innovative in vitro diagnostic testing solutions for HIV and other infectious diseases. Our reliable, non-invasive HIV diagnostic tests and specialty research tools are helping doctors and scientists improve health and health care around the world.
We are the authorized distributers of Calypte Biomedical corporation,USA
http://biopharmafze.com/index.html
i don't think so....
http://biopharmafze.com/aboutcompany.html
About Company
BioPharma FZE :- is a Dubai ( United Arab Emirates) based company operating under Dubai Airport free zone "Formed Pursuant to Law No. 2 of 1996 with Limited Liability 1996 " with Corporate Office in DAFZA, Building 7WA G040, Dubai, UAE.
We are specialized in distribution and marketing of Medical and Surgical Equipments , Laboratory Tools and Requisites across Middle East and South Asian countries.
BioPharma FZE is founded by joining the efforts of highly experienced marketing expertise in the Middle East region in association with Calypte Biomedical Corporation
BioPharma FZE is an organization with competent experience of promotion and marketing of Medical and Laboratory Equipment Supplies in these regions since 2010 with solid business management experience
We are operating though a partner's network of highly professional local distributors that secure unique market channels to different business sectors in our selected markets for distributing our products.
OUR MISSION
Our Mission to provide Quality Products by applying BEST business practices in every field we operate. To maintain a professional relation with health care professionals by supplying them of all ethical information and tools helping them to have better knowledge to help them in treatment strategies for their patients .
"As major achievement BioPharma FZE signed agreement with CALYPTE BIOMEDICAL CORPORATION who develops in vitro testing products to improve the diagnosis of Human Immunodeficiency Virus (HIV) infection, sexually transmitted diseases and other chronic diseases."
http://biopharmafze.com/products.html
2012-08-29 05:03:58 - New Medical Devices market report from GlobalData: "Calypte Biomedical Corporation (CBMC) - Financial and Strategic SWOT Analysis Review"
Calypte Biomedical Corporation (Calypte) is a diagnostic company. It carries out the development, manufacture and marketing of in-vitro testing algorithms for improved diagnosis of HIV infection and other chronic diseases. Its product line includes Aware line of low cost rapid tests, Aware HIV-1 BED Incidence test and Aware Messenger specimen. The company provides a variety of antigens and recombinant proteins along with proprietary reagents, buffers, and other specialty products for the enhancement of immuno-diagnostic assays. It has manufacturing facilities in the US, Thailand and China. Calypte is headquartered in Oregon, the US.
The company seeks to collaborate with other companies to gain access to its research and development, manufacturing, marketing and financial resources. The business strategy of the company focus on
increasing marketing and sales in the countries, where its products are registered and seeking additional product registrations in countries with emerging markets. It is also planning for the clinical trials of Aware 2 and keeping its operating costs low.
http://reports.pr-inside.com/new-market-research-report-calypte-biomedical-r3347559.htm
Form 10-Q for CALYPTE BIOMEDICAL CORP
http://biz.yahoo.com/e/120814/cbmc10-q.html
who: HIV Rapid Tests: Progress of the Prequalification of Diagnostics process
it seems calypte make progress too? any thoughts?
http://www.who.int/diagnostics_laboratory/120720_hiv_rapid.pdf
http://www.who.int/diagnostics_laboratory/110204_hiv_rapid_v2.pdf
http://www.who.int/diagnostics_laboratory/101206_hiv_rapid_rev.pdf
OSUR Approval Green-Light's CEMI's OTC Program?
Brian Marckx, CFA
OraSure's Rapid HIV FDA Approved For OTC Market
On Tuesday (7/3) the FDA approved OraSure's (OSUR) OraQuick over-the-counter rapid HIV test. The test, which uses an oral swab (saliva) as the sample and is basically identical to the test sold to the clinical market, is the first HIV test to be approved for home use. While the approval was not a total surprise given that in May an FDA advisory panel (Blood Products Advisory Committee) voted unanimously in favor of approving the test, there were some lingering doubts given concerns about the risk of false positives from the test. OraSure's shares jumped on the news on Tuesday and are up over 15% from the closing price on Monday.
Chembio (CEMI) has noted in the recent past that they might pursue FDA approval of their Sure Check (lateral flow, using blood sample) rapid HIV 1/2 test for the OTC market. In September 2011 the FDA provided guidance that Chembio will need to perform additional studies in order to submit for an Investigational Device Exemption (IDE). FDA clarified the regulatory pathway and Chembio has since completed the instructional manual for home-use testing. But before spending any substantial time and financial resources on an OTC program, including running clinical trials, Chembio was waiting for the FDA's decision on OSUR's OTC test. Tuesday's news now opens the door for Chembio to pursue OTC approval of its Sure Check rapid HIV test, which is already FDA approved for the clinical market. As we've noted previously, as eventual FDA approval of a Sure Check OTC test is still uncertain (although chances are likely now more favorable with FDA approval of OraQuick) and not a near-term event, we do not yet include any contribution from it in our model.
http://finance.yahoo.com/news/osur-approval-green-lights-cemis-225512677.html
Form 10-Q for CALYPTE BIOMEDICAL CORP
http://biz.yahoo.com/e/120515/cbmc.pk10-q.html
15-May-2012
Quarterly Report
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
Forward-Looking Statements
This Management's Discussion and Analysis contains forward-looking statements regarding our future plans, regulatory reviews and approvals, timing, strategies, expectations, anticipated expense levels, projected profitability, business prospects and positioning with respect to market, demographic and pricing trends, business outlook and various other matters (including contingent liabilities and obligations and changes in accounting policies, standards and interpretations) and expresses our current intentions, beliefs, expectations, strategies or predictions. These forward-looking statements are based on a number of assumptions and currently available information and are subject to a number of risks and uncertainties.
Forward-looking statements are generally identifiable by the use of terms such as "anticipate," "will," "expect," "believe," "should" or similar expressions. Although we believe that the bases of the assumptions on which the forward-looking statements contained herein are reasonable, any of those assumptions could prove to be inaccurate given the inherent uncertainties as to the occurrence or nonoccurrence of future events. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. Therefore, actual outcomes and results may, and are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors, including the potential risks and uncertainties set forth in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2011 and Item 1A of Part II below and relate to our business plan, our business strategy, development of our proprietary technology and our products, timing of such development, timing of FDA and international regulatory reviews, market acceptance of our products by governmental and other public health agencies, health care providers and consumers, characteristics and growth of our market and customers, protection of our intellectual property, implementation of our strategic, operating and human resources initiatives, benefits to be derived from key personnel and directors, our ability to commercialize our products, our ability to obtain an increased market share in the diagnostic test market, our assumptions regarding cash flow from operations and cash on-hand, the amount and timing of operating costs and capital expenditures relating to the expansion of our business, operations and infrastructure, implementation of marketing and distribution channels, our distribution agreements and strategic alliances, our liquidity and capital resources, our ability to obtain additional capital as, and when, needed, and on acceptable terms, changes in health care policy in the United States or abroad and general economic conditions specific to our industry, any of which could impact sales, costs and expenses and/or planned strategies and timing. If we are not able to generate sufficient liquidity from operations and current potential resources or are unable to raise sufficient additional capital, this could have a material adverse affect on our business, results of operations, liquidity and financial condition, and we may be required to discontinue operations altogether. We assume no obligation to, and do not currently intend to, update these forward-looking statements.
Overview
During the first quarter of 2012, we continued to focus on our research and development operations, and building upon the promising results of the completed internal trials of our new AwareTM 2 HIV-1/2 oral fluid rapid test, which showed an accuracy of 100%. We have contacted the FDA and started the process to conduct clinical trials.
Our ability to obtain a small stream of funding through private placements of common stock has enabled us to continue our operations. On October 10, 2011, we entered into a memorandum of understanding ("MoU") with a private investor to secure funding needed to initiate the FDA approval procedures for our new AwareTM 2 product. The MoU contemplates an initial investment of at least $1,000,000 through 2012, contingent upon the Company following an agreed upon budget plan, and potentially up to $4,000,000 from additional investors. Although the MoU expresses the expectation of the parties that the investor will assist us in raising an additional $4 million from other investors, no party is under a contractual obligation to invest any funds beyond the $1 million to be invested pursuant to the MoU, and there can be no assurance that we will be able to raise the additional funds. Based on our revised revenue and expense forecasts, we anticipate that we will be required to raise additional financing beyond the initial $1 million from the MOU in order to fully fund our efforts to obtain FDA approval of our AwareTM 2 product.
Revenue for the first quarter of 2012 decreased 73% from the first quarter of 2011. Our product sales tend to be irregular from quarter-to-quarter, particularly with our BED product, as public health and research institutions begin or conclude various studies to monitor the incidence of HIV infection within their subject populations. We remain focused on our strategy of increasing marketing and sales in a subset of countries where our products are registered, seeking additional product registrations in countries where we have a high likelihood of making sales, developing new products for the western markets and keeping our operating costs low. We continued to make our AwareTM BED Incidence tests and AwareTM HIV-1/2 OMT rapid tests during the quarter.
--------------------------------------------------------------------------------
Business Environment
Although we have received regulatory approval in a number of countries, there is a long lag time between regulatory approval and sales. In our target markets, government ministries of health or similar government and nongovernmental agencies are the primary purchasers of our products, typically through a "lowest-cost" tender process. These purchasers have historically purchased blood-based HIV tests. We have had to overcome the obstacle of changing these purchasers' mindsets from preferring tests that use the current blood standard of care. We have expended much time, money and effort to try to convince government bodies and non-governmental organizations to try our oral fluid tests, both for its ease of use, efficiency and lower-cost benefits.
We consider these efforts to be part of a strategy in which the "standard of care" for HIV diagnosis evolves from the exclusive use of blood tests to more widespread use of non-invasive oral fluid-based tests. If we can successfully change the standard of care, we expect to reach a point at which our revenue will increase significantly. We cannot forecast whether or when this point will occur, as it is largely governed by factors beyond our control.
Outlook
We believe the demand for fast, easy-to-use HIV tests is strong and growing. By many accounts, governments are requiring more testing for HIV and allocating more funds to such testing, and non-governmental organizations and charities have increased their funding for HIV testing too. Although we believe that we will be able to increase market acceptance of our products and our market position, there are external factors that could adversely affect demand for our products, including global economic conditions that affect funding for HIV testing and national policies regarding HIV testing adopted by foreign governments.
In order to accomplish our business plan and meet our financial obligations, we must:
? Reduce accounts payable and other debt and associated fixed costs.
? Increase marketing and sales of our current products through our distribution network.
? Conduct a successful clinical trial for our AwareTM 2 product.
In 2012, we remain focused on our strategy of increasing marketing and sales in the countries where our products are registered, seeking additional product registrations in countries where we have a high likelihood of making sales, planning for the clinical trials of AwareTM 2 and keeping our operating costs low.
Financial Considerations
Our net cash used in operating activities in the first three months of 2012 was approximately ($267,000), compared to $81,000 net cash provided by operating activities in first three months of 2011. A primary factor in our positive cash flow during the first quarter of 2011 was the $171,147 of QTDP grant received. In both periods, the cash used in operations was primarily for development and commercialization of our rapid tests, as well as for our selling, general and administrative expenses.
During the first quarter of 2012, we had a net loss of $0.3 million. At March 31, 2012, we had a working capital deficit of $2.5 million. Our cash balance at March 31, 2012 was $0.1 million. We received $50,000 in additional advances from investors after March 31, 2012 and our cash balance as of May 15, 2012 was $22,000. We do not believe this cash balance is sufficient to enable us to fund our operations through the remainder of 2012 unless we continue to receive financing as provided in the MoU.
We currently have 800,000,000 shares of common stock authorized, of which 778,095,129 shares are issued and outstanding or reserved for issuance under current financing arrangements and our incentive plans. If additional financing is available to us, it will likely be in the form of one or more equity or convertible debt transactions. At the current market price of our common stock, we do not have sufficient authorized common stock to raise the capital necessary to execute our business plan and achieve self-sustaining cash flow. The condensed consolidated financial statements do not include any adjustments that might result from the outcome of these uncertainties.
Critical Accounting Policies and Estimates
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Good work! Thank you Otto!
I agree!
10-K for CALYPTE BIOMEDICAL CORP
http://biz.yahoo.com/e/120322/cbmc.pk10-k.html