Hi Ernie,
RE CEMI recent price weakness:
For the non-oral tests, a negative surprise has developed:
10k: "For example, the European Union and other jurisdictions have a requirement that diagnostic medical devices used to test human biological specimens must receive regulatory approval known as a CE mark, or be registered under the ISO 13.485 medical device directive. The letters “CE” are the abbreviation of the French phrase “Conforme Européene,” which means “European conformity.” ISO (“International Organization for Standardization”) is the world’s largest developer of standards with 148 member countries. As such, export to the European and other jurisdictions without the CE or ISO 13.485 mark is not possible. In 2007, we received ISO 13.485 certification, in 2008, we received a CE registration for our Chagas test, and during 2009 we expected to receive CE registration for our two FDA approved HIV tests. However, additional data and documentation has been requested and there are no assurances that we will be able to secure this certification although we are not aware of any material reason why such approval will not be granted. However, if for any reason a CE registration is not granted, our ability to export our products could be adversely impacted."
In the conf call during the Q&A the speaker said "we may have a problem"
I think that is the reason for some selling.
However, this appears to still be around the corner for the short term:
10K "Oswaldo Cruz Foundation OEM DPP® Agreements - During 2008 we signed four agreements with the Oswaldo Cruz Foundation (FIOCRUZ) in Brazil relating to products based on our DPP® technology for Leptospirosis, Canine Leishmaniasis, screening for HIV 1/2 with oral fluid samples, and a 5-band multiplex point-of-care confirmation test for HIV 1&2. We have completed development of three of these products (Leishmaniasis and the HIV screening and confirmation tests), and we have substantially completed development of the Leptospirosis test. Two of the three products developed have been submitted for regulatory approval evaluations in Brazil and we expect the third will be filed very shortly; we expect that these products will be approved by Brazilian regulatory authorities (ANVISA for HIV tests and MAPA for canine test), although there can be no assurance, during the first part of 2010, triggering initial orders as well as approximately $1 million in technology transfer fee payments to the Company.
Chembio is a party to several grants and other funded contract research and development agreements with entities that have included the United States National Institutes of Health (NIH), the CDC, the Foundation for Innovative and Novel Diagnostics (FIND), and the Infectious Disease Research Institute (IDRI). Work with these organizations involves efforts to develop rapid POC tests, all on DPP®, for Tuberculosis, Malaria, Leprosy, Leishmaniasis, Leptospirosis, Syphilis, HIV, Influenza, Hepatitis C, and other conditions in humans and animals. In each instance there is a demonstrated need for a simple, accurate, cost effective rapid diagnosis at the point of care.
In addition, the US HIV sales from Innervess are up sustantially and significantly, so that appears to be doing very well.
In the long term, they have enough things going on that I find them to be very compelling. This is not a small 2-3 person company working on one project, like we see so often with these OTC companies . They have over 100 employees, and their products are being used currently. The pipeline therefore should be taken seriously. From their website:
"Chembio is a party to several grants and other funded contract research and development agreements with entities that have included the United States National Institutes of Health (NIH), the CDC, the Foundation for Innovative and Novel Diagnostics (FIND), and the Infectious Disease Research Institute (IDRI). Work with these organizations involves efforts to develop rapid POC tests, all on DPP®, for Tuberculosis, Malaria, Leprosy, Leishmaniasis, Leptospirosis, Syphilis, HIV, Influenza, Hepatitis C, and other conditions in humans and animals. In each instance there is a demonstrated need for a simple, accurate, cost effective rapid diagnosis at the point of care.
Chembio has a new oral fluid HIV test which it developed with its DPP® technology. International evaluations are ongoing and clinical trials for U.S. market approval are expected to begin during 2009 and continue in 2010. Also, Chembio has a Cooperative Research & Development Agreement (CRADA) with the CDC to develop the world’s first rapid, POC combination screening and confirmatory test for Syphilis. This test, DPP® Syphilis Screen & Confirm, uniquely combines two markers on a single test strip which will enable a clinician to differentiate active versus past syphilis infection from a single finger-stick whole blood sample within 20 minutes. This will enable treatment decisions to occur at the POC. Development of the syphilis test is completed and several field and other studies are scheduled in the U.S. and globally during 2009 and 2010." |
