Calypte und die Zeit nach AIDS2004 in Bangkok
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China trials AIDS vaccine
Sunday, March 13, 2005 Posted: 2:50 AM EST (0750 GMT)
BEIJING, China (Reuters) -- China, criticized for a slow initial response to its AIDS/HIV crisis, has begun its first human trials of a new AIDS vaccine, Xinhua news agency said.
A 20-year-old man became the first volunteer to receive the AIDS vaccine on Saturday, followed by seven others, four of them women, Xinhua said.
Some 49 volunteers aged between 18 and 50 would receive the tests in three phases, the first lasting 14 months.
Experts have faulted China for being slow to recognize a growing AIDS problem, exacerbated by the cover-up of the blood-selling schemes in the central province of Henan that infected scores of people in the mid-1990s.
The government estimates that China, with a 1.3 billion population, has 840,000 people with HIV. Activists and experts say a more accurate figure would be between 1 million and 1.5 million.
The United Nations has said that the number of HIV/AIDS victims in China could rise to 10 million by 2010 unless serious steps are taken to fight the disease.
On World AIDS Day in 2003, Premier Wen Jiabao shook hands with AIDS patients at a Beijing hospital in a symbolic display of commitment to fighting the disease.
But efforts to step up AIDS prevention remain shackled by politics and conservative attitudes toward sex.
The AIDS virus has infected more than 43 million people worldwide and killed 25 million. The incurable virus spreads through sexual contact, blood products and mothers' milk but can be controlled to some degree with cocktails of drugs called highly active antiretroviral therapy.
The International AIDS Vaccine Initiative has said dozens of potential vaccines are being tested and more than 70 human clinical trials have taken place although none has yet promised to conquer the virus
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| Boardmail an "Kade_I" |
Wertpapier: Calypte Biomedical |
13 Mar 2005, 08:08 PM EST
Msg. 66448 of 66451
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10K week at HIV, Time for the audited truth.....
Sales?
Net Profit?
Cash Burn?
Rapid Test Sales?
BED incidence test sales?
Suppliers and royalty holders paid in full?
Role Of Magic Johnson?
13 Mar 2005, 08:17 PM EST
Msg. 66449 of 66451
(This msg. is a reply to 66446 by thatmaybe.)
Jump to msg. #
Rounding Third.
I guess this 10K will be real "enlightening" eh that maybe..
When did Tim say the rapid sales would start? Wasn't it second quarter of 2004?
1-29-2004
Clinical tests will start in China in "a few weeks" ..Richard George
12-1-2004
Clinical tests have started in China on 1500 subjects we hope to have it concluded by the end of the year. Results will be out 2 weeks after last person enrolled... Richard George
Early March 2005
Uh well there have been problems and we only have one section of the Chinese clinical tests done.. Bad weather and holidays have uh delayed us. Do you know how hard it is to find heaters in China? Uh we are not sure exactly when we will be done but still plan on selling our tests in China by mid 2005 ... Richard George.
Boy I think Dr. George will need to change his initials to TC very soon.
Du findest immer gleichgesinnte nicht wahr joelü...
An deren Meinungen haltest du dich immer fest ..
Gruß
C.O
spätestens nach dem nächsten 10k halte ich dir die berechtigung der fragen nochmal unter die nase...viel zeit hast du bis dahin nicht mehr. laß dir schon mal ein paar passende ausreden einfallen, warum roy hinkleys fragen berechtigt sind. von mir aus auch wieder diese: "4379. Mensch Joelü den Roy the Toy kennt doch jeder.. "
How does an American company obtain regulatory approval in China?
In China, regulatory approval for a product is granted only for products manufactured in China and only to the Chinese manufacturer of such product. As a result, for us to maintain control of our products in China, we plan to manufacture our products in China through a joint venture involving BTBP.
Page 55
Who is BTBP?
BTBP is a biotech company that manufactures multiple vaccines for both viral and bacterial infections. The National Vaccine & Serum Institute of the Peoples' Republic of China currently owns approximately 66% of BTBP's outstanding shares.
Page 45
How are you planning to penetrate the Chinese market?
We believe that the key to our penetration of the Chinese market will hinge on the success of the Beijing Calypte Joint Venture with Marr Technologies Limited in obtaining regulatory approval for and manufacturing and marketing our rapid HIV test products in China.
Page 61
What are the details of this agreement?
In November, 2003, we became the 51% owner of a joint venture, Beijing Calypte Biomedical Technology Ltd. (the "Beijing Calypte Joint Venture"), created to market existing and potential new products in the People's Republic of China ("China"). The remaining 49% of the joint venture is owned by Marr Technologies Limited, an affiliate of Marr Technologies BV ("Marr"), our largest stockholder, with a security ownership of approximately 27% of our outstanding stock as of December 16, 2004.
Page 41
What progress have you made in China to begin regulatory approval of your products?
On December 1, 2004, we announced that we had commenced a clinical trial program for our rapid HIV-1/2 test platform and our HIV-1 Western blot supplemental tests in The People's Republic of China. The trial will evaluate the sensitivity and specificity of our three rapid HIV-1/2 Antibody Tests; Blood, Oral Fluid and Urine. The trial will also evaluate the Company's HIV-1 Western Blot supplemental tests in Blood and Urine. We plan to test approximately 1,500 patients using no less than 7 locations that will perform the rapid HIV ½ tests and using at least 3 laboratories that will perform the HIV-1 Western Blot supplemental tests. We expect to complete the data collection by the end of this year and have a full statistical analysis available approximately two weeks after the last patient has been enrolled. We will release the performance results when the trials have been completed and certified by our Chinese contractor. Our objective is to file the required regulatory applications with the Chinese FDA (SFDA) in early 2005.
Page 81
How and where did you manufacture the product for the clinical trials?
… BTBP has made facilities available to us to manufacture the rapid test products required for clinical trials in China.
Page 45
I put together information out of a CC and the latest 424B3 filing that relates to China. It's in the form of an interview. I made it that way because it is easier to read and is more concise than the filing. If you want to check the context just refer to the page number below each paragraph. You should refer to the 424B3 filing to see all of the risks related to each subject mentioned here.
What details can you give us in terms of your full scale manufacturing plant in China?
CC 10/28/2004 (Dr. George)
“…We have already started to select our staff; we will start the training in advance of the time when we get approval. Once we have completed the clinical trials in China, you know, once we see what the results of this clinical trials are we’re going to know that approval is either going to be coming or it’s not going to be coming, cause we know what we have to achieve, in terms of performance. So, again this is all planed to be done concurrently with everything coming together before the time when we have the ability to start selling in China. If we can get the process done earlier, we might consider some exportation from that facility.”
What are your prospects for sales in China?
Early indications, based on meetings with Chinese authorities in which both we and representatives of our joint venture partner participated, lead us to expect that there is great potential for revenues from the sale of rapid HIV tests in China.
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What is the size of the market there?
From the CC 10/28/2004 (Dr George)
“… You know, the size of that market is really mind boggling. Because, China has such a – they have a significant and a serious problem with the spread of HIV in their population and China has now recognized the seriousness of that threat to their population and have recognized that if it is not addressed very quickly ant appropriately that it could actually begin to affect the economic growth that they have experienced in the last few years. Just to put it a little bit in perspective; sex workers in China; there are approximately 30 million of them that are known registered sex workers. The Chinese government tests those people every quarter. So, if you just do the math; four times 30 million that’s 120 million tests per year, just for that one small segment of the Chinese population. China has recently made the offer to their people, that, they will give a free AIDS test to anyone who request it. There are 1.3 billion people in China. I don’t mean to suggest that all 1.3 billion people are lined up for an HIV test, but someone who is administering that program in China and at the CDC, he said, about 600 million tests this year in the program and remember people who need testing for HIV don’t test one time. It’s a recurring need because people, being what they are, find out they’re negative and they see that as encouragement to continue to behave in the old ways. I think you get a sense, it’s a huge market. I think we have some good products for that market.”
Gruß
C.O
wann kommen denn umsätze zu dem test, hmmm? sag mal?
2005 nicht mehr...
Oh when the truth comes marching In
Oh when the truth comes marching In
Lord I want to be in that number
When the truth comes marching in.
Won't be no Jonas, Won't Be No Lies
You can read it with your own eyes
When the 10K comes marching in.
achso, das ist von roy hinkley umgetextet. schönes lied...
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| Boardmail an "Kade_I" |
Wertpapier: Calypte Biomedical |
15 Mar 2005, 10:02 AM EST
Msg. 66486 of 66488
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10K today or tomorrow, if HIV wants to stay within 75 day time frame. My guess is after close tomorrow.
wir haben dieses Posting wegen Verstoßes gegen die Forumrichtlinien aus dem ARIVA.DE-Diskussionsforum gelöscht.
Ihr ARIVA.DE-Team
ich schaue mir den dollar auch gerne mit dem fernrohr an!
a propos luppe... wie geht es deinem depot joelu? *gggggggggggggggg*
augrid: meiner augrid position geht es beschissen. mittlerweile schmerzfrei, da ein verkauf wohl nicht mehr lohnt. zufrieden?
weißt du, was der unterschied zu caly ist: bei augrid ging es schneller, es war nicht so ein langes zappeln, winden und hoffen, wie es bei caly noch ist. von daher nicht so qualvoll...
oh yeah! das mit augrid war volle scheisse aber bei caly denke ich nicht dass der schuss hinten rausgeht ;-)
Ich denke die Führung von HIV (Calypte)ist seit einiger Zeit zur sehr beschäftigt, um neuigkeiten rauszubringen, obwohl sie da sind aber zum Zeitpunkt nicht veröffentlicht werden können.
Oder Meinen einige, Trials in Afrika und China ohne Zeitaufwand vollbracht werden köpnnen??
Gruß
C.O