Calypte und die Zeit nach AIDS2004 in Bangkok
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ich sehe es wie von ganz anfang schon als highriskinvestment.
ich will mit caly keine 4.säule aufbauen sondernmir nur einen neuen 911er mit geilen felgen kaufen *gggg*
joelu darf dann mal hinten mitfahren (sorry aber vorne sitzt eben heidi klum....)
Die Reissleine die man als solches bezeichnet, wird mich pers. nicht betreffen da Ich anfangen werde bei Kursen um die 5-6-7 $ zu verkaufen...
Das diese Ziele sehr Realistisch sind das wissen viele hier, können es aber nicht wahr haben weil es nunmal für die sehr .....
Wir werden bei der Party dabei sein und die anderen ???
Gruß
C.O
wenn es caly schafft im chinesischen markt fuss zu fassen & die test's gut ankommen geht die post ganz anders ab....
falls china nur bedingt kauft gibt es ja noch afrika.
was will man marktmässig besseres haben? asien und afrika sind hiv-mässig extrem stark betroffen & brauchen solche test's ganz dringend.
urin-test sind schnell und unkompliziert! das ist doch genau das richtige!!
in Joelü's sprache zu gestalten damit er seine verluste mit Caly wieder in Gewinn umwandeln sollte muhahahaha
du weißt schon wie ich das meine
Gruß
C.O
FOR RELEASE, SEPTEMBER 29, 2004
Company :
Trinity Biotech plcIDA Business Park
Southern Cross Road
Bray, Co Wicklow
Ireland
Tel :
(353)-1-2769800Contact :
Brendan K. Farrellbrendan.farrell@trinitybiotech.com
Trinity Biotech Receives FDA Approval
For Uni-Gold™ Recombigen
® HIV Test usewith Fingerstick Wholeblood
DUBLIN, Ireland (Wednesday, September 29, 2004)….
Trinity Biotech plc(NASDAQ: TRIB) today announced it has received approval from the US Food & Drug
Administration (FDA) for the use of its Uni-Gold™ Recombigen
® HIV Test with fingerstick whole blood samples. The test, which gives results within 10 minutes, is now
approved for the detection of antibodies to HIV in human serum, plasma, venous and
finger stick whole blood and is the first and only device to be approved for use with all
four sample types. A finger stick whole blood sample is normally a drop of blood taken
from the finger or thumb with a lancet. This is the simplest and most rapid procedure
for producing a sample for HIV testing.
Uni-Gold™ Recombigen
® HIV is simple to use, provides rapid results and is 100%sensitive and 99.7% specific. The product has previously received CLIA waiver for use
in detecting HIV 1 antibodies in venous whole blood samples and Trinity has already
applied for CLIA waiver for finger stick whole blood.
Trinity Biotech is a leading supplier of Rapid HIV tests in the US, African and Asian
markets and has sold approximately $6million of these products in the first three
quarters of 2004.
Commenting on the FDA approval, Ronan O’Caoimh CEO said “While we were
extremely pleased last year to get serum, plasma and whole blood approval for Uni-
Gold™ HIV , today’s finger stick whole blood approval is of significantly greater
importance as it opens up for Trinity a much larger public health market including CDC
more-more-more
-2-
funded programmes. In addition, this finger stick approval provides full access to a new
doctor’s office market for Trinity Biotech. We have already applied for CLIA waiver for
the finger stick whole blood claim and confidently expect to receive it in the next month.
This latest approval means that our Uni-Gold™ HIV test can now be used in all
significant segments of the US market. This includes hospitals, reference laboratories,
physician’s offices, STD clinics and community based organisations. We will continue to
sell Uni-Gold™ HIV to hospitals, and public health sites through our established
salesforce of over 85 industry professionals and will market to the physician’s office
segment through appropriate distribution channels.
Uni-Gold™ Recombigen
® HIV Test continues to enjoy competitive advantagesparticularly in the areas of speed to test result and sensitivity. These advantages are now
further enhanced by the approval to use multiple sample types with our product. With
the increase in worldwide funding to fight HIV/AIDS through programmes such as
PEPFAR (President’s Emergency Programme for AIDS Relief) and the WHO 3x5
programme, there will be a significant increase in the use of rapid HIV tests over the
coming years and Trinity Biotech is very well positioned to take advantage of this growth
in the marketplace”.
Trinity Biotech develops, acquires, manufactures and markets over 500 diagnostic
products for the point-of-care and clinical laboratory segments of the diagnostic market.
The broad line of test kits are used to detect infectious diseases, sexually transmitted
diseases, blood coagulation disorders, and autoimmune diseases. Trinity Biotech sells
worldwide in over 80 countries through its own salesforce and a network of
international distributors and strategic partners. For further information please see the
Company’s website:
www.trinitybiotech.com.Forward-looking statements in this release are made pursuant to the "safe harbor" provision of the Private
Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements
involve risks and uncertainties including, but not limited to, the results of research and development efforts,
the effect of regulation by the United States Food and Drug Administration and other agencies, the impact of
competitive products, product development commercialisation and technological difficulties, and other risks
detailed in the Company's periodic reports filed with the Securities and Exchange Commission.
das was du heute zur kenntniss nimmst, war uns schon klar nur ....
Die ganzen begründungen will ich hier nicht nochmal auflisten...
Meine Empfehlung an dich studiere weiter um zu verstehen warum Calypte besser als Orasure, Trinity usw. ist
Gruß
C.O
Bekanntermassen kommt ja Hochmut vor dem Fall ;-))
Grüße, ZN
ist doch klar dass wie hier von hot-stocks sprechen. logo gibt es konkurrenz & logo ist es riskant aber weshalb sind wir alle hier??
April 4, 2005
Dr George, President and CEO
This has been a very successful year. There have been many accomplishments and I can conclusively say that we have never been closer to the goals that I have set out for this Company, since I became CEO over a year ago. I have unequivocally moved the ball down the field. We have completed the scientific validation of our rapid technology. We have completed the acquisition of all the necessary intellectual property to compete on the widest scale. We have completed the technology transfer and quality control of our Thailand plant and accordingly have the ability to ship product to Africa. And most importantly, we have entered the final stage prior to sales; the regulatory process. To that end we have started registration trials in Uganda in the past quarter and will be engaged in similar trials in six additional countries in Africa during the second quarter. We expect to receive approval from a number of countries in Africa during the second quarter, but these statements are forward looking. We are also in the process of completing the registration trials in China, and look forward to announcing the results this month. This as well, is the final stage prior to sales in China, and despite the slippage in the time-line we are still on track for an approval in mid 2005. While we have not completed the trials in the time frame we had originally anticipated (I want to repeat) we are still on track and I will encourage everyone not to loose sight of it. I am firmly convinced that the progress made in 2004 and early 2005 have assured success for Calypte, and we will be judged accordingly in the coming year. Much of that success has been due to the patience and loyalty of our investors and our strategic partners.
And that continues to be illustrated today as minutes ago we executed an agreement for the issuance of 8 million dollars in senior secured convertible notes and warrants in a private placement with accredited investors. The notes baring interest at the rate of 8 percent per annum have a two year term and are convertible into approximately 26.7 million shares of the Company’s common stock at a price of $0.30 per share, which is at the moment, premium to today’s market close. The warrants total approximately 38.7 million shares of our common stock at a price of $0.325 per share; they are 5 year warrants. The Company can force the exercise of 12 million of the warrants under certain conditions, which could generate an additional $3.9 million dollars. We also entered into a new credit facility agreement with Marr Technologies BV our largest stockholder, similar to the facility we had in place in 2004. We have access to an additional $5.5 million from the issuance of 9 percent promissory notes that we may issue through December 31, 2005. The issuance of these promissory notes are subject to unanimous Board approval, which must take place before the commitment period ends. Any notes that we issue under this facility will be due and payable December 31, 2006. If we force exercise of warrants or raise additional financing it will reduce the availability of funds dollar for dollar under the credit facility. With the 8 percent notes and availability of the credit facility we believe we have the resources necessary to continue the commercialization of our HIV 1-2 rapid diagnostics and generally meet our business plans through 2005. We plan to file an amended 10KSB later this week to reflect the subsequent events and our auditors will issue a duel dated opinion coincident with this 10 KSBa in which we expect they will remove our going concern qualification as a result of issuance of the notes and establishment of the credit facility. In parallel we intend to continue to explore additional efficiencies in our operations. We not only want our cash to last longer but we want our margins to be higher as we begin commercialization. It has never been clearer to me how large this opportunity is and I am committed to maximizing it in every way possible. In the past year I have cut our burn rate, however this task is not complete and we must enter into a launch in sales cycle of our rapid tests. I remain committed to obtaining the highest possible margins on our products. We will announce further details as these efficiency initiatives are implemented throughout the year.
In just a few minutes I would like to take you through a review of operations, but first I let me turn the call over to Rick Brounstein to review the quarterly results.
Für die die sich das garnischt angehört haben
Weiter gehts auf der
http://finance.yahoo.com/q/mb?s=HIV
Gruß
C.O
Now I’d like to review operations - the question on everyone’s mind is “what’s happening in China?” I was in China about three weeks ago and met with the contractor conducting clinical trials; I am pleased to confirm that we are near completion. The testing of the HIV positive and negative subjects has been completed. Remaining are approximately 100 subjects with other viral infections, such as Hepatitis C. The Chinese government is interested in seeing the cross reactivity in patients with HCV. China faces a large HCV problem and despite our own findings that show no cross reactivity, we respect their desire to pursue this data on a small sample size. Finding these people however has been an arduous process but we seem to be nearing the completion. We therefore believe that the study will be completed this month, at which time we will immediately file the necessary data and applications to the SFDA for review and approval. We will also announce the results of the trial once the final report has been submitted to us by the agency that is conducting the trial. In addition, we and our partners in China continue to seek the fastest route to get our product into the Chinese market. There have been several significant accomplishments on that front that we are in the process of completing and we will discuss them in greater detail as they are definitely concluded. Whoever, despite the delay in finishing the clinical trials we still believe that we are on schedule to have sales in China in the second half of 2005. On each visit to China I become even more convinced that the market is very large and available to a company with innovative and competitively priced technology. There currently is no company in China with an approved rapid oral fluid or urine HIV test. We firmly look to fill that void this year. During my last visit to China I was able to attend the conference sponsored by the Ministry of Health and the Global Business Coalition on HIV/AIDS. The key note speakers at that meeting were the Vice Premier of the Peoples Republic of China Madam Wu Yi and Ambassador Richard Holbrooke Chairman of the GBC. The theme of this conference was that testing must be the main focus of HIV/AIDS prevention. It was also enlightening to hear from Madam Wu the extent of China’s commitment to HIV/AIDS prevention and to testing. I invite you to visit the GBC website at www.businessfightsaids.org and review the account of the Beijing conference. You cannot help but conclude that Calypte will be a major force in the Chinese HIV testing efforts. During 2004 we have also made progress in our efforts to introduce our Rapid HIV Test into the African and Asian markets.
The manufacturing technology has been transferred to our manufacturing partner in Thailand. Clinical trials in support of regulatory approvals in Africa and Asia are in progress and will be expanded to additional territories in the coming months. We expect to have our first approvals in Africa in the current quarter and we will update you as they transpire. In past calls I have updated you on progress in the ramp-up in sales of the BED Incidence assay. For new listeners, the BED Incidence assay is a new technology that Calypte licensed from the Center for Disease Control and Prevention in the spring of 2004. This assay was developed by the CDC for use in targeting appropriate populations for HIV prevention efforts. The assay does this by identifying the number of HIV positive people in a specific population where infections occur within the past six months. These populations where new infections are appearing with the highest frequency are those populations in the greatest need for intervention programs. The BED assay is then used to re-test these populations in a year or more to quantify how affective the intervention program has been. A reduction in the number of new infections is evidence of an affective prevention program. Such metrics are indispensable to insure that the prevention dollars are well spent. Since the introduction of the BED Incidence assay many groups feel that the test has great application for clinical use as well as its well proven use in surveillance. Calypte has been contacted by several groups urging us to seek regulatory approval to use this assay for clinical purposes. Calypte has had conversations with both the CDC and the FDA and we have been encouraged to make this regulatory filing. We plan to meet soon with the FDA and with the CDC to discuss filing an IDE, an Investigational Drug Exemption application. Since acquiring a license for this test in 2004, Calypte made the first test available for sale in October 2004. In that same month the CDC announced they would support the use of the BED assay in their surveillance effort world wide. To date three workshops have been held to teach scientists from many countries to use this new technology. These workshops were held in the US and two in Africa. Additional workshops are scheduled throughout 2005. Following each workshop we experience many calls asking for information on the test and ordering instructions. To date we have shipped kits to South Africa, Ethiopia, Kenya, Zimbabwe, China, Uganda, Brazil, Taiwan and to the CDC Contract Laboratory in the United States. Some countries have ordered more than once. We expect this increase in sales to continue throughout 2005 and into 2006. We believe that we will see a marked up-tick in sales for this innovative test in the coming year.
I would like to turn the call over to Dick Van Maanen, Vice President of Operations to give you a more detailed update on our progress in Africa and Asia. He recently concluded a world wide trip and we are pleased with the results of the journey.
Thank you Sower!
Best Regards
C.O
TOTAL
GROSS NET SHARES
FINANCING SOURCE PROCEEDS PROCEEDS ISSUED
---------------- -------- -------- ------
Bristol 12% Convertible
Debentures and Warrants $ 562 $ 505 1,476.1
8% Convertible Notes 3,232 2,594 46,084.3
Other 2002 Financings 750 730 2,720.3
Mercator 12% and 10%
Debentures (1) 4,550 3,650 37,529.5
Marr 2003 Private Placements 12,500 11,900 28,333.3
May 2004 PIPE 9,300 8,769 23,250.0
July 2004 PIPE 1,488 1,384 3,720.0
April 2005 8% Convertible
Notes and Warrants (2) 8,000 7,667 --
------- ------- ---------
Total $40,382 $37,199 143,113.5
======= ======= =========
der abrutsch wird ihnen die schuhe ausziehen. und ZN: es wird nicht mal mehr für ein altes klapprad reichen!!!
ich werde die beiden, giant und broker, mitnehmen müssen, wenn sie per anhalter am strassenrand stehen werden!!!
achtung: caly hat unter 0,24 geschlossen! das nächste kursziel sind die 0,18$. werde euch mal eine kleine analyse einstellen.
HIV
CALYPTE BIOMEDICAL CP
Daily Commentary
Our system posted a WAIT today. The previous SELL recommendation that was confirmed was made on 03.10.2005 (29) days ago, when the stock price was 0.3200. Since then HIV has fallen -28.13% .
It is now a market with a firm decision to try the lower end. We already have warned you before with our previous confirmed SELL signal. Anyway, we believe that you have sold your shares and even opened a short sale position.
Our WAIT tag says all that is to say. Keep on staying short or at cash until the next signal. Do not bother yourself with any further buying or selling, as long as the WAIT tag stays.
Today a Short Black Candlestick was formed. This implies relatively weak selling pressure with little price movement.
www.UCSY.com
sag mir mal deine ehrliche Meinung ....... natürlich möchte ich keine Zukunftsweisheit sondern ne Zockermeinung.
tictactictactictac....und dann: bummmmmmmm Kurs unter 0,10$ und RS
200 Mio Aktien bei sagen wir mal 100 Mio Auftrag na wie schaut den dann dein Kurs bei Caly aus ? ernstgemeinte Frage von mir an dich
diese firma bescheisst seit jahren ihre anleger!
die jetzigen 0,23\\$ wärenm vor dem splitt gerade mal 0,00766\\$. da seid ihr schon in augrids spähren. und das obwohl man angeblich nur fortschriite gemacht hat!!!
laßt euch nichts erzählen, finger weg von dem wert!!!
nächstes kursziel sind die 0,18\\$. sollten die nicht halten, seid ihr schnell bei 0,12\\$ als nächste unterstützung.
selbst kade meldet sich nicht mehr!!!
....und die, die sich noch informieren wollen..
Rec. Time Action Price Volume
11:08:40 AM Bid 0.22 124700
11:08:38 AM Trade 0.22 2000
10:59:04 AM Trade 0.23 1200
10:58:14 AM Trade 0.23 1000
10:58:14 AM Ask 0.23 23000
10:48:42 AM Trade 0.23 1000
10:48:42 AM Ask 0.23 24000
10:34:14 AM Bid 0.22 109700
10:27:58 AM Ask 0.23 25000
10:25:40 AM Bid 0.22 101700