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HIV; waarom lager?

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  1. [verwijderd] 27 november 2007 19:24
    Van Ihub geplukt :

    New Estitmates from the one Analyst:

    Revenue Est
    Qtr Dec 07 - 190.00K
    Qtr Mar08 - 450.00K
    Year Dec07 - 660.00K
    Year Dec08 - 5.43M
  2. [verwijderd] 3 december 2007 14:56
    Calypte Recognizes World AIDS Day with Product Donation
    Second Donation in Kenya

    PORTLAND, Ore.--(BUSINESS WIRE)--Dec. 3, 2007--Calypte Biomedical Corporation (OTCBB: CBMC), a developer, manufacturer and marketer of HIV diagnostic tests, announced today that, in honor of World AIDS Day, it has donated 4,000 Aware(TM) HIV-1/2 OMT (oral fluid) tests to the National AIDS Control Council (NACC) of the Republic of Kenya, in conjunction with its distributor in Kenya, Ultralab & Allied Services Ltd. The tests being donated to NACC will be used in a pilot program utilizing oral fluid and rapid HIV testing with the objective of expanding Kenya's current blood-only testing protocol to include an oral fluid testing alternative. The current donation is in addition to the 10,000 Aware(TM) HIV-1/2 OMT tests that Calypte donated previously to the Ministry of Health and the National HIV/AIDS and STD Control Program (NASCOP). Some of the tests donated previously were used by NASCOP in a comparative study demonstrating that the performance of an oral fluid HIV testing algorithm is comparable to or better than Kenya's current blood-based algorithm.

    The Aware(TM) HIV-1/2 OMT test was specifically designed to eliminate barriers to testing and encourage more people to get tested. The test is safe, highly accurate and non-invasive. Since no blood needs to be drawn, administration of the test eliminates the pain and discomfort, as well as safety concerns, associated with blood-based testing. The test is also easy to use, requiring little training and providing results in about 20 minutes.

    "We are excited about the Aware(TM) HIV-1/2 OMT test now being available in Kenya," said Professor Alloys Orago, Director of the NACC. "This oral fluid test will encourage more people in Kenya to opt for getting tested for HIV."

    "We are pleased to support the government of Kenya in the fight against HIV/AIDS with this donation," stated Dr. Guido Lippoli, Calypte's Director of Sales and Marketing. "In support of the Kenyan Government's emphasis on the importance of knowing your HIV status, each person being tested with the Aware(TM) HIV-1/2 OMT test will receive a blue 'I Am Aware' bracelet to wear with pride, demonstrating that they know their HIV status."

    "In addition to being safe and non-invasive, the Aware(TM) HIV-1/2 OMT test is also cost effective," added Dr. Lippoli. "Everything needed to collect and test an oral fluid sample is included in the test kit. In contrast to conventional blood tests, no additional supplies such as syringes, lancets or needles are required. The Aware(TM) HIV-1/2 OMT test has an eighteen-month shelf life (1 1/2 year) and can be stored at room temperature. Calypte believes these attributes make Aware(TM) the only oral fluid HIV test on the market that can realistically support ongoing, high-volume oral fluid-based testing globally."

    tinyurl.com/yvcxre
  3. [verwijderd] 6 december 2007 14:09
    Calypte's Chinese Manufacturing Subsidiary Obtains ISO 13485:2003 Certification of Quality Management System

    PORTLAND, Ore.--(BUSINESS WIRE)--Dec. 6, 2007--Calypte Biomedical Corporation (OTCBB: CBMC), a developer, manufacturer and marketer of HIV diagnostic tests, announced today that its Beijing China manufacturing subsidiary, Beijing Marr Bio-pharmaceutical Co., Ltd., Beijing China, a joint venture between Calypte and a Marr Group subsidiary ("Marr") has successfully passed its quality system audit and obtained certification of its quality system to the international standard, ISO 13485:2003. Certification was provided by TUV SUD Management Service GmbH of Munich Germany.

    The ISO 13485:2003 standard specifically addresses the application of quality system principles to medical device products and is based on the ISO 9001:2000 quality management standard with many requirements specific to the medical device industry. Regulatory authorities in several countries around the world such as US FDA, Health Canada, China, the European Union and elsewhere base their requirements for good manufacturing practices (GMP) on the ISO quality standards. Conformance to the ISO standards is one of the many requirements for compliance with the European Union Medical Device and In Vitro Diagnostics Directives and obtaining CE Marking.

    Beijing Marr Bio-pharmaceutical Co. was established by Calypte and its joint venture partner, Marr, to manufacture its Aware(TM) line of rapid HIV tests, including the Aware(TM) HIV-1/2 OMT product for both the Chinese and international markets. The Aware(TM) HIV-1/2 OMT product is a rapid test that uses oral fluid for a diagnosis of HIV-1 or 2 infection in as little as 20 minutes with an accuracy comparable to U.S. FDA approved blood based laboratory HIV EIA tests. Beijing Marr Bio-pharmaceutical Co. is currently manufacturing the Aware(TM) HIV-1/2 OMT product for export from China and this certification expands the number of countries to which the facility can export product. Beijing Marr Bio-pharmaceutical Co. is awaiting approval from the China State Food and Drug Administration (SFDA) to distribute and sell the product within China.

    Roger I. Gale, Calypte's President and Chief Executive Officer, explained, "This is the first ISO quality system certification of our China manufacturing facility and we are very pleased that TUV SUD has granted Beijing Marr's quality management system certification to ISO 13485. This internationally recognized certification affirms Beijing Marr's GMP system and complements our recent USAID approval of the Aware(TM) HIV-1/2 OMT rapid test, documenting the product's excellent performance characteristics. Together, we believe, this clearly documents Calypte's company-wide commitment to quality products and we are excited that the international community continues to recognize our quality commitment to our customers. In addition, this certification should facilitate our product registration process in many countries and with international regulatory bodies that require a third party certification of a GMP and quality management system before product approval can be issued."

    David K. Harris, Chief Executive Officer of Beijing Marr Bio-pharmaceutical Co., Ltd. stated, "We are very happy to have received this certification from TUV SUD, which recognizes the commitment we have made to providing quality products and helps us pave the way not only for gaining access to additional international markets, but which we believe will facilitate the SFDA's approval of Beijing Marr's quality system in conjunction with our pending application for the Aware(TM) HIV-1/2 OMT rapid test."

    About The Marr Group:

    The Marr Group is a private group of companies controlled by the Safin family. Marat Safin, a London School of Economics graduate, is the President of the Group. The Group has a large and diverse number of investments and projects globally, principally in Europe, the Far East, the Middle East and the CIS.

    About Calypte Biomedical:


    P.
  4. [verwijderd] 6 december 2007 22:16
    Samenvatting CC van Ihub :

    Synopsis:

    Roger Gale, Chris Kafka and Jerry Dodson at table participating.

    Roger Gale: Small biomed Company which provides HIV related products for diagnosis. Focusing in countries with huge needs: China, Africa, Russia and India.

    They own their own intellectual property for U.S. and European Union future marketing, but will take some time to do it.

    They have the license to all rights for the current test product as well as future products including multibased tests on one test product.

    Weaknesses of the company are its small size, limited financial resources and the global acceptance of innovative testing that are different than the standard of blood.

    Strengths of the company are the global sales reach. Traditionally, they have used distributors globally and currently have twelve distributors serving twenty six countries. The BED Incidence test is promoted by the CDC and sold directly by Calypte.

    They are transitioning toward operating close to markets...in the UAE, the Middle East and Africa, through offices in the UAe and in Geneva. They are intending to manufacture in India and the UAE and participate in research and development with India.

    Purchases of the product are through private and public means. The private market focuses on businesses and individuals, the public market is governmental funding by non domestic funding through international organizations, the WHO, UNAIDS, World Bank, USAID, Pepfar and various other programs mentioned. There is also private fudnign through various foundations and organizations such as the Gates Foundation down to the local NGOs.

    Calypte states they need more time to expand, their capability is recent increased staffing, increased product support, the anticipated introduction of new products in 2008 with the inclusion of the Calypte test format to include testing for other diseases. Mr. Gale stated he couldn't discuss new technologies but the company are working on them.

    Questions answered to email questions:

    Mineseeker: The situation is currently in abeyance. Calypte received the order of 1 to 5 million tests to be used in South Africa with the support of Nelson Mandella. This required an investment of 3 million dollars. Mineseeker ordered $80,000 worth of tests consisting of 20,000 plus tests. $495,000 in investing was received of the $3,000,000. There was a dispute with the investors of the $3,000,000 when Calypte was delisted from the AMEX and they did not proceed with the investment. The contract issue will be dealt with after the New Year, at which time they will be contacted and asked if they still wish to proceed or the matter will be closed. The purchased tests are still in Thailand because Mineseeker has not instructed Calypte on where to deliver the tests.

    China: Current status on Approval:

    It was filed two ywars ago. The SFDA has asked for additional research which was done and refiled. Following that, the first and second command of the China SFDA was arrested. The first in charge was executed and the second is either pending execution or has been executed. This paralyzed the SFDA with little or nothing moving through it. There have been some signs of the SFDA proceeding, including asking administrative follow up questions. There are two more processes to be completed, the first is the technical review followed by the determination of the SFDA board whether to approve. The company has no idea when this will occur or when the SFDA will issue the determination.

    Level of Sales - Sales Forecast:

    Mr Gale has stated the company will not make the forecast. There have been a series of events which have occurred which he is reluctant to delineated. He stated India is slower than expected. They expected a project in Nigeria whichdidn't occur. They believe they will be "ontrack with sales early next year."

    Chris Kafka spoke of India and the market. He has met with NACO which is the largest purchaser of HIV tests in the world. The barrier right now to sales in India is NACO criteria addresses only blood HIV testing. Calypte and the distributor are working with NACO to expand the criteria to include OMT testing. NACO is considering studies to implement the use and protocol for the use of oral fluid testing.

    Part of the problem is there is an established institution that has a vested interest in blood testing who don't wish to see oral fluid testing (Personal note: I assume "big blood" companies that don't have the oral technology)

    Sales re: USAID Waiver Tests: USAID is a major cornerstone for Calypte. Inclusion on the USAID Waiver List indicates progress for Kenya, Uganda and Tanzania and they are beginning to see activity in these countries. WHO approval, manufacturing with CE Mark and USDA approval will only enhance those efforts.

    UAE: Office opened in the UAE and they have a small team in Dubais. The current challenge in Dubais is the UAE approval was granted to the distributor of the product. Now the distributor is no longer assigned to Calypte, the approval needs to be again requested through the new chose distributor when one is chosen.

    Question from Shareholder in Audience, Pat Campbell:

    China FDA Application does allow manufacturing in China and export to other countries. At this time, Calypte is manufacturing a small order to go to South Africa at the China plant.

    Pepfar listing on website...it is there as approved and is listed as Calypte Aware OMT test on the approval list, rather than under "Aware" as the BSP test is listed as "Aware BSP test"

    Status of WHO Approval and why it hasn't been approved by WHO:

    WHO suspected evaluation programs of HIV tests in February of 2005. They announced they would revamp the program again in September of 2005 but didn't do so, issuing another notice they would revamp the program in September of 2007. Calypte has been in contact with the WHO, requesting and waiting for guidence on the process for the processing of the application for WHO approval and are in line for quick approval. They are in contact with WHO through their Geneva Office which was developed to gain tighter ties with WHO and other NGOs there.

    Manufacturing Questions: It was asked why there was the "only manufacturing facility (Note: Now changed effective today for export from China through the Beijing Plant) was in Thailand and Thailand did not have approval for the test.

    Kris Kafka answered this question stating Thailand has not accepted applications for new HIV tests in the past five years, feeling there were enough tests within the country. It was the party line, until this last year. Calypte met with the ministry of health and had successful meetings with them to consider the inclusion of an oral fluid test within their approvals, however a military coup took over and the process went aside. They are awaiting word to see when it will occur.

    There was a question about CDC BED tests: It was stated by Roger Gale that the CDC recently put out a solicitation for tenders to domestic lab based testing. Previously, this was solely done in New York and the CDC was soliciting other parties to contract to administer BED testing, as well. This will mean Calypte will have to work with more than one customer in the US, which he stated to be a good thing. He stated the CDc was one of the largest consumers of the test.

    World AIDS Day: Calypte donated 4,000 tests to Kenya. Follow up to donation of last yea
  5. [verwijderd] 6 december 2007 22:17
    Vervolg :

    World AIDS Day: Calypte donated 4,000 tests to Kenya. Follow up to donation of last year. Calypte staff has taken several trips to Kenya to work with the product. Two staff members were in Kenya for the run up to prepare for Worlds AIDS day where there was expected to be a large amount of testing with oral fluid. Kenya was not ready to handle the numbers and used blood. Staff was also sent to work with WHO, Pepfar and other organizations for World AIDS day. The result was activity from Tanzania and Uganda. Expecting commercial success next year.

    Brounstein - The situation involving Mr. Brounstein was when Calypte moved offices from CA to Portland, he declined to move to Portland, however stated he wanted to be involved with the company. He did good work with the company and a constructive termination occurred when he declined to move. He continued to be involved with the company and stayed on the team until the past few months. In March of this year, Brounstein and Gale both contributed to the PIPE funding in cash and in kind. Brounstein worked for shares of stock instead of cash. Recently, there was a restructure, reducing the number of administrative costs to compensate for the increased R&D and marketing costs which are the focus of the company and resulted in Mr. Brounstein's job being eliminated. It was stated he has every opportunity to work on projects forward. Mr. Gale apologized for the terse release, believing individuals realized the situation from former releases and Mr Brounstein leaving the company ahd nothing to do with any adverse developments, that he had done a terrific job.

    Financial Information: In march a Pipe of $5.2 million was raised as well as a series of warrants. The Pipe was to get through the third quarter expenses. The investors agreed to exercise the warrants when the company needed cash. Marr has recently exercised warrants as have other investors, which has brought cash into the company. $13.5 million dollars in warrants and investors have honored the commitment to exercise the warrants.

    The SEC declined the first satement and informed the company how to refile it. They did so and that one was declined as well. Rule 144 required the investors to hold investment for 12 months. This rule was changed three weeks ago to reflect a six month period of time and the shares that were issued in march were grandfathered in. They are waiting for the changes to be gazetted and then sixty days following gazetting, the change comes into law...it is anticipated mid February, the investors will have the shares.

    Current Shareholders over 5 percent: Marr Tech BV holds 19% of the total shares of the company and is the largest shareholder. There are four other investors who have 29% of the aggregate, ranging from nine percent to six percent each. 4% is held by the Directors, mostly by Mr. Gale who bought and paid for his shares the "hard way."

    There were some statements about working with the Gates Foundation and other large foundations which I didn't hear because of another commitment.

    There was a comment by a "shareholder" who stated Directors made a "lot of money" and needed to answer to shareholders. It was clarified Directors do not receive compensation for their participation on the board, that it was a fallacy. Only recently did they receive shares of stock for their participation through released options.

    These are my notes on the webcast.

    Bottom line: Delay in meeting projections. Product being manufactured in China for South Africa export. Mineseeker deal hinged on investment by investors who backed out after the delistment from the AMEX, India sales delayed until NACO accomodates oral HIV testing as qualifying for use and protocols are established, Thailand pending following coup upheaval, marketing continuing in Africa and still awaiting SFDA approval on the China timeline after upheaval in SFDA with heads of the organization. UAE to be refiled for approval with new distributor. CDC getting more contracts for BED test use in U.S...forecasts should be on target for early next year.

  6. gustaaf1e 12 december 2007 17:09
    quote:

    Jommeke schreef:

    Intussen al op 0.09 - Dat is niet zo leuk. Wanneer gaan die spleetogen eens iets beslissen ?
    Jommeke: Zie de laatste alinea van je vorige posting. ff wachtuh....
    Dit gekke aandeel wordt soms met enkele honderden stuks 5 of 10 % terug of naar boven gezet.
    G
  7. [verwijderd] 12 december 2007 17:25
    quote:

    1gustaaf schreef:

    [quote=Jommeke]
    Intussen al op 0.09 - Dat is niet zo leuk. Wanneer gaan die spleetogen eens iets beslissen ?
    [/quote]
    Jommeke: Zie de laatste alinea van je vorige posting. ff wachtuh....
    Dit gekke aandeel wordt soms met enkele honderden stuks 5 of 10 % terug of naar boven gezet.
    G
    Ah die koele Gustaaf ! We moeten toch 150% stijgen, willen we terug op 23 zitten. Ik ben wel overtuigd dat het een goed product is, anders zat ik er niet in. Maar dat het zo lang duurt eer ze wat verkopen is toch tergend. Ook de onzekerheid hoe lang ze het nog trekken zonder verkoop. En als ze verkopen moeten het nog grote hoeveelheden zijn want de verwatering van het aandeel is al zo groot.
  8. gustaaf1e 13 december 2007 00:24
    Ja Jommeke, daar zit veel in. En voor het eind van het jaar willen er nog 'n paar van hun stukjes af zo te zien, al stelt deze omzet nominaal natuurlijk helemaal niets voor.
    China-goedkeuring kan ook best nog volgend jaar worden. Gezien de werkwijze daar durft het management geen datum te noemen.
    De kans op goedkeuring is naar ik uit hun berichtgeving eerder heb begrepen wel groot. Met dat in het achterhoofd is instappen nu eigenlijk zonder veel risico, want bij chinese goedkeuring krijg je natuurlijk een flinke spike.
    G
  9. [verwijderd] 13 december 2007 00:26
    quote:

    1gustaaf schreef:

    Ja Jommeke, daar zit veel in. En voor het eind van het jaar willen er nog 'n paar van hun stukjes af zo te zien, al stelt deze omzet nominaal natuurlijk helemaal niets voor.
    China-goedkeuring kan ook best nog volgend jaar worden. Gezien de werkwijze daar durft het management geen datum te noemen.
    De kans op goedkeuring is naar ik uit hun berichtgeving eerder heb begrepen wel groot. Met dat in het achterhoofd is instappen nu eigenlijk zonder veel risico, want bij chinese goedkeuring krijg je natuurlijk een flinke spike.
    G
    Ja, en dan staan we misschien terug op 0.23 :( of denk je dat we dan veel hoger gaan ?
  10. [verwijderd] 16 december 2007 22:32
    Uit de nieuwsbrief van Ceocast :

    Calypte Biomedical Corporation (OTCBB: CBMC), a company that engages in the development, manufacture, and distribution of in vitro diagnostic tests, primarily for the diagnosis of human immunodeficiency virus, entered into the Seventh Amendment to 2005 Credit Facility Agreement with Marr Technologies, BV, its largest stockholder and affiliate to Marr Technologies Asia Limited, the company's joint venture partner in Beijing Marr Bio-Pharmaceutical Co., Ltd. Pursuant to the Credit Facility Amendment, Marr was given the option to convert, for a one year period commencing on December 4, 2007 and ending on December 3, 2008, all or any portion of the principal amount and accrued interest of the promissory notes issued under the 2005 Credit Facility and outstanding during the term into shares of common stock of the company at the conversion price of $0.16 per share. Also the company entered into Amendment No. 3 to the Secured 8% Convertible Promissory Notes with Marr, lowering the conversion price of the 8% convertible promissory notes issued to Marr in the PIPE dated April 4, 2005 and all subsequent notes issued, and to be issued, to Marr thereafter for the payment of interest on the notes from $0.30 per share to $0.16 per share of common stock. The stock ended the week unchanged at $0.11.

  11. gustaaf1e 9 januari 2008 19:06
    quote:

    fox1405 schreef:

    Iemand nog nieuws van het HIV front? Weinig handel, geen nieuws, saai!

    Fox
    Nee, Fox, (nog) geen nieuws.
    G
  12. [verwijderd] 10 januari 2008 15:10
    quote:

    1gustaaf schreef:

    [quote=fox1405]
    Iemand nog nieuws van het HIV front? Weinig handel, geen nieuws, saai!

    Fox
    [/quote]
    Nee, Fox, (nog) geen nieuws.
    G
    Nu wel, en wel een goede halve stap!!

    Calypte's Chinese Manufacturing Subsidiary Obtains Medical Device Manufacturing Permit
    PORTLAND, Ore.--(BUSINESS WIRE)--Jan. 10, 2008--Calypte Biomedical Corporation (OTCBB: CBMC), a developer, manufacturer and marketer of HIV diagnostic tests, announced today that its Chinese manufacturing subsidiary, Beijing Marr Bio-pharmaceutical Co., Ltd., ("Beijing Marr"), has received a permit to manufacture medical devices issued by the Beijing branch of the Chinese Food and Drug and Administration. The manufacturing permit enables the facility to manufacture in vitro diagnostic tests for the domestic Chinese market once specific product approval is received. The permit is required before Beijing Marr can sell an approved product within the country. Beijing Marr is currently awaiting approval from the China State Food and Drug Administration (SFDA) to distribute and sell Calypte's Aware(TM) HIV-1/2 OMT rapid diagnostic test within China.

    Beijing Marr, a joint venture between Calypte and a Marr Group subsidiary was established to manufacture Calypte's Aware(TM) line of rapid HIV tests, including the Aware(TM) HIV-1/2 OMT product for both the Chinese and international markets. The Aware(TM) HIV-1/2 OMT product is a rapid test using oral fluid to diagnose HIV-1 or HIV-2 infection in as little as 20 minutes with an accuracy comparable to that of U.S. FDA approved blood based laboratory HIV EIA tests.

    Roger I. Gale, Calypte's President and Chief Executive Officer, commented, "Coming on the heels of the recent ISO 13485 Certification of Beijing Marr's manufacturing facility, this permit is another significant milestone that brings us much closer to our objective of manufacturing and marketing our rapid test product for the Chinese market."

    David K. Harris, Chief Executive Officer of Beijing Marr stated, "This permit is required because the State Food and Drug Administration moved regulatory oversight for HIV tests from the Drug Division to the Medical Device Division. Our team has been working diligently to obtain this permit to ensure that we will be permitted to manufacture our Aware(TM) HIV-1/2 OMT test once it has been approved for sale in China."


    P.
  13. [verwijderd] 10 januari 2008 15:11
    Calypte's Chinese Manufacturing Subsidiary Obtains Medical Device Manufacturing Permit
    Thursday January 10, 9:00 am ET

    PORTLAND, Ore.--(BUSINESS WIRE)--Calypte Biomedical Corporation (OTCBB: CBMC - News), a developer, manufacturer and marketer of HIV diagnostic tests, announced today that its Chinese manufacturing subsidiary, Beijing Marr Bio-pharmaceutical Co., Ltd., (“Beijing Marr”), has received a permit to manufacture medical devices issued by the Beijing branch of the Chinese Food and Drug and Administration. The manufacturing permit enables the facility to manufacture in vitro diagnostic tests for the domestic Chinese market once specific product approval is received. The permit is required before Beijing Marr can sell an approved product within the country. Beijing Marr is currently awaiting approval from the China State Food and Drug Administration (SFDA) to distribute and sell Calypte’s Aware™ HIV-1/2 OMT rapid diagnostic test within China.
    Beijing Marr, a joint venture between Calypte and a Marr Group subsidiary was established to manufacture Calypte’s Aware™ line of rapid HIV tests, including the Aware™ HIV-1/2 OMT product for both the Chinese and international markets. The Aware™ HIV-1/2 OMT product is a rapid test using oral fluid to diagnose HIV-1 or HIV-2 infection in as little as 20 minutes with an accuracy comparable to that of U.S. FDA approved blood based laboratory HIV EIA tests.

    Roger I. Gale, Calypte's President and Chief Executive Officer, commented, "Coming on the heels of the recent ISO 13485 Certification of Beijing Marr’s manufacturing facility, this permit is another significant milestone that brings us much closer to our objective of manufacturing and marketing our rapid test product for the Chinese market.”

    David K. Harris, Chief Executive Officer of Beijing Marr stated, “This permit is required because the State Food and Drug Administration moved regulatory oversight for HIV tests from the Drug Division to the Medical Device Division. Our team has been working diligently to obtain this permit to ensure that we will be permitted to manufacture our AwareTM HIV-1/2 OMT test once it has been approved for sale in China.”

    biz.yahoo.com/bw/080110/2008011000544...
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