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