Calypte und die Zeit nach AIDS2004 in Bangkok
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| Eröffnet am: | 05.07.04 15:03 | von: Kade_I | Anzahl Beiträge: | 6.056 |
| Neuester Beitrag: | 19.01.06 14:27 | von: Der_wahre_. | Leser gesamt: | 188.494 |
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Support/Resistance
Type Value Conf.
resist. 0.43 2
resist. 0.42 6
resist. 0.40 2
resist. 0.38 6
resist. 0.37 6
resist. 0.36 3
resist. 0.34 2
resist. 0.33 8
resist. 0.32 2
resist. 0.31 3
supp 0.30 4
supp 0.26 8
supp 0.25 2
supp 0.24 2
supp 0.23 2
supp 0.20 8
bei good news sind das die süssen statisten die im rückspiegel untertauchen, aber ich verstehe dass auch statistiker etwas zu tun haben müssen.
by the way....wo ist denn bei augrid der erste widerstand bei 0,0000000001?? *g*
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Wertpapier: Calypte Biomedical |
es wird eben immer so gedreht, wie ihr es hier braucht...soviel zum thema statistik.
by the way, wo ist der erste widerstand bei augrid? ich würde sagen, das ganze ding ist ein einziger widerstand...muhahahhahahahaha
und, falsch der erste größere ist nicht bei 0,0000000001, sondern erst bei 0,00000000015. ich hoffe diese antwort kann dich etwas erheitern...
jetzt verstehe ich auch ein wenig besser weshalb du hier so selbsticher auftreten kanns....wer solche aktien im depot hat, weiss was das wort rendite bedeutet *G*
by: sowerharvest
Long-Term Sentiment: Strong Buy 03/04/05 12:18 pm
Msg: 3037 of 3038
I want to give you reasons why I've put my confidence in Dr. George's ability to make this Company a success...
First his credentials:
"Senior Vice President of Research and Development, Infectious Diseases for Orasure Technologies (Nasdaq: OSUR). He was Chief of the Developmental Technology Section of the Division of HIV with the Centers for Disease Control and Prevention (CDC). Dr. George has extensive experience at the CDC where he was employed in various roles for 35 years."
Source: Calypte website
Now, some of my own observations...
In all his CC's he has never avoided any questions and has always been polite and courteous. I have never heard him say anything that was false or misleading. He has a passion for Calypte and the new Ani platform. You can tell by his past that this disease is of great concern to him. He has experience with governments and has success in obtaining product approvals. As far as management is concerned I believe he is their greatest asset.
The rapid tests...
By a track record I mean they were validated in Thailand and met or exceeded the accuracy of other products that are currently selling in the US and arround the world.
Marr...
I would also like to see another investor come in that will help carry us through. Marr is gaining more power and I'm not sure of their integrity. One of the ways of controling a business is to buy up shares until you own a majority. I don't think they are attempting this because the latest financing is by means of a loan. I share your concern.
I, too, hope we all do well.
sower
by: sowerharvest 03/04/05 01:01 pm
Msg: 3043 of 3045
CC to announce license agreement with Ani Biotech
October 5, 2004
Thank you and good morning. Thanks for joining me on today’s call. As many of you know companies are rewarded for successfully developing technology and ultimately distributing the applied version in the market place. Equally important but often overlooked and seldom appreciated is the daunting challenge of securing the patents or licenses to patents that govern the commercialization of these technologies. Our industry is characterized by a vast array of aggressively defended or sometimes completely un-acquirable intellectual property and patents. And successful navigation through this IP landscape determines in large part which companies have freedom to operate and where. Ultimately this element defines the scope of the market and the size of the opportunity. Today we are able to proudly say that we have completed our IP acquisition efforts. We are armed with a strong patent portfolio and can compete on the widest scale. Until now we have been focused on completing the commercialization of our current Rapid HIV 1-2 Testing Platform in developing world countries where potentially blocking patents are not filed. While this approach was less than ideal it was certainly prudent considering the fact that the regions with the greatest need and market opportunity include some of those developing countries, such as China, Russia, and most of Sub-Saharan Africa. However, while we have been developing and validating out Rapid HIV test in these unprotected markets, Calypte has been simultaneously focused on attaining world-wide licenses to patents covering lateral flow assays for our Rapid Diagnostic Test. Simply stated these lateral flow patents govern the crucial flow of urine, blood or oral fluid to the portion of the test device that ultimately indicates the persons disease status. Two red lines on the test device signifies HIV positive and one red line, HIV negative.
Without the necessary lateral flow licenses we would be unable to address important markets such as the United States, Canada, Europe and Japan for HIV and would be limited to territories not covered by our current patent and license portfolio prior to this deal. While this pursuit could be financially rewarding it would none the less be limiting. Today’s agreement breaks down these territorial barriers for HIV, and in parallel opens up new opportunities for us in the broader diagnostic category of sexually transmitted diseases or STD’s. Over the course of the last few months we have met these stated goals by putting in place the final touches to our IP portfolio with the announcement of a sub-license agreement Abbott with the “Guire/Swanson” patents and yesterday with Bio-Rad for HIV 2. Today we are pleased to announce the culmination of this licensing initiative with the final piece of the puzzle. Today we announce that Calypte has entered into a world-wide licensing technology transfer and equipment purchase agreement with Ani Biotech, a clinical diagnostics company located in Helsinki, Finland. The agreement with Ani grants us an exclusive license to a lateral flow platform that we can use to develop, manufacture and sell diagnostic tests for the major STD’s including HIV, Hepatitis B, Hepatitis C, Human Papillomavirus, Syphilis, Gonorrhea, and Chlamydia when oral fluid or urine are the sample media. Calypte has also acquired a non-exclusive license to develop, manufacture and sell the same STD diagnostic tests when blood, serum, plasma, or urogenital swabs are the sample media. This agreement also includes the purchase of fully automated production equipment that will allow us to economically make commercial quantities of test kits sufficient to satisfy our future needs. This equipment has been well validated and currently is in use in Ani’s Helsinki plant. We believe that Ani’s patent-pending
diagnostic test device and sample applicator allows Calypte to compete globally with these technologies and largely concludes our intellectual property licensing effort for the lateral flow assay device platform. After careful study of the new technology and based on extensive legal, clinical and product due diligence, both Calypte and Ani believe that the Ani technology does not infringe on any issued lateral flow patents. To that end, Ani has filed the necessary patent applications to protect this valuable new technology. With the execution of this agreement Calypte and Ani scientists will begin a collaboration that will train Calypte scientists to use the Ani Platform. The initial collaboration will focus on transferring one of the Calypte HIV 1-2 Rapid Tests into the new format. I believe this task can be completed rather quickly. Shortly thereafter we will complete the transfer of all three of the formats, urine, oral fluid and blood to the Ani Platform. I parallel, Ani will begin production of the manufacturing equipment and subsequent installation and validation will occur in the Calypte Rockville manufacturing facility. Once this initial phase is completed we will produce several lots of each device for the clinical studies of our HIV Rapid test initially for the U.S. We expect to follow with clinical studies in Europe, Japan and elsewhere world-wide as appropriate. It is our goal to begin USFDA submission process with the necessary IDE’s for blood, urine and oral fluid HIV 1-2 Rapid Tests using this new format in late 2005. Upon acceptance of our IDE by the FDA we will conduct clinical trials in the U.S. leading to a PMA submission and contingent upon positive results from these trials, approval to sell our assays into the professional market and subsequently into the over-the-market as well.
Die Verzögerung ist zwar wirklich ärgerlich, ich für meinen Teil bin mir aber sicher, dass die Ergebnisse sehr gut ausfallen werden. Denke die Verzögerung liegt an den Chinesen, die sich mächtig Zeit lassen.
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Fach stehen muß ?
Ich denke auch,daß die Ergebnisse sehr gut ausgefallen sind..
Ansonsten wären Einstellungen der Personen in China fataler fehler..
Nennen wir es, die Ruhe vor dem Sturm...
Gruß
C.O
Thank you very much, I’ll entertain questions.
(Moderator) First question we’ll take from Tom DeHooty with MTB, Investment Advisers. Please go ahead!
Q. Good morning! Hi, how are you? The clinical trials you mentioned, in China and Sub-Saharan Africa, I guess I was under the impression that you had already started the trials in China.
A. No, we have not. We have had some unexpected delays due to contract negotiations with our collaborating institutions in China. But we are, I think, all teed up now. People are leaving in fact this week to go there and deal with those clinical trials. Unfortunately there’s a national holiday going on in China as we speak as often seems to be the case, I think and we won’t probably get started until a week from now so that’s pretty much what’s going on Tom.
Q. Just to clarify a bit more. Given the nature of the problem there, why the delays, why?
A. You know it’s just business issues it has absolutely nothing to do with the science or with the products that we’re trying to introduce. It’s just trying to get people to agree to the study protocols, getting the necessary approvals from the IRB’s, and getting the financial matters settled. You know I wish that these things were easier to do and quicker to do but that’s just the reality of business.
Moderator) The next question we have is from Bill Querk with RBC Capital Markets. Go ahead.
Q. Yes, thanks and good morning. A couple questions for you. First off is, during the prepared comments you mentioned that the “intellectual property was largely finished for the U.S.” I was hoping you could expand on that comment. I don’t know if there’s I guess additional intellectual property that you’re looking for or?
A. Yes, let me explain why we said “largely finished.” First, the ability to make and sell lateral flow devices; it is finished. For the ability to make HIV tests, in other words, to use the HIV 2 antigens, to have contracts for the antigens that we are using in our tests, that is also finished. Now, as we go forward we’re going to be developing additional tests, as I said in the prepared remarks, for STD’s. Now, that process is just beginning. The strategy that I would like to use for that is, I would really like to do it as quickly as I can possibly do it which means that if there are companies out there with technology that we can acquire through either a license or an out right purchase, that we believe we can convert into our own platform and get to the market very quickly, I would prefer to go that route, rather than go through the development process. For the development process, a lot of the antigens that we most likely will be needing to develop tests like Chlamydia and something like Hepatitis C, we are going to need additional licenses for those particular analytes, those negotiations are underway. It’s going to be that sort of negotiations and acquisition of licenses is going to be an ongoing process for as long as we’re in business. It’s just the nature of the business.
Q. Alright, understood, and then secondly, with respect to plans to roll out an over-the-counter HIV product; I was hoping you could comment a little bit, I guess my understanding is that typically for HIV one of the restrictions from over-the-counter is that you need to have a counseling aspect there in the event there is a positive. I was hoping you could just comment on that?
A. That’s absolutely true. Let me just back up and say that in one of my previous lines I was very involved in the introduction of the products from Home Access and prior to that Johnson & Johnson for the over-the-counter sample collection kits that were licensed back in the late 90’s early 2000’s and I’m very much aware of what is required to bring that type of product to market. The first thing we have to do is to get approval to sell into the professional market and that’s why I have said we will go the IDE route and go ahead and get that before the Food and Drug Administration. In the United States it will be, if we are in fact the first, we will have to sort of blaze a trail for how this is to be done. Typically you have to provide both pre-test and post-test counseling. I’m not prepared to tell you exactly how we will deal with that but, just to tell you how we might deal with it; pre-test counseling; the precedent has been set that it can be in the form of a written message. So, we can include a booklet in the over-the-counter kit that gives all of the necessary pre-test counseling. Of course that would have to be approved by the Food and Drug Administration. Post-test counseling is again, a rather complicated situation, but you know we’ve got a lot of great technology now. One approach that we can take is to provide an eight hundred number that people can call and it will connect them to a call center. There are many of those types of call centers located all around the United States, in fact all around the world, that currently answer medical type questions. Another approach would be some sort of inter active internet program where people can log on and get their results after the appropriate code is entered; they will have their result; get a message if they want to do instant messaging with a counselor, that’s possible. There’s a lot of ways we can do that, and we’ll decide what is the most appropriate way after discussions with the FDA and other public health agencies that have a deep concern about this type of testing.
(Moderator) We have a follow-up question with Tom Dehooty with MTB, Investment Advisors, please go ahead!
Q. Can you give us some idea of the licensing arrangement with Ani in terms of what the royalty payment would be going forward? And similarly with the licensing arrangement you announced yesterday?
A. Tom, we’re not going to give out what the royalty rate is that we’re going to pay to either Ani or to Bio-Rad for - really, for competitive reasons. We were requested not to that by the people who granted the licenses and I think you can probably figure out why the really wouldn’t like to have that out there. I gave the, what we’re paying Ani in terms of an upfront payment. I will say that the royalty that we’re paying to Ani is a very reasonable royalty and it is a variable royalty based upon where we sell the test. We’ll pay a little higher royalty for tests sold in the United States, Japan, places like that where the market will bear a little bit higher price than we’ll pay in Sub-Saharan Africa where we are certain to be under certain pressures to sell at a cheaper price. That’s about all I can say right now and so, I hope that’s good enough to satisfy you.
Q. One other question relative to manufacturing. How soon will your manufacturing facilities actually be up and running?
A. Very soon. We are already preparing the space, or very soon will be. We’re getting bids as we speak and to answer your question I think conservatively mid 2005 would be a reasonable estimate of when we will have it installed, validated and ready to produce product.
Q. So, if you were to sell actual product into Sub-Saharan Africa you would be making that product out of Rockville?
A. Initially, no. As I said also in the presentation we are continuing with our current business strategy of making product in Thailand to sell into Sub-Saharan Africa, into markets where our ability to do business is not blocked by lateral flow patents.
Q. Ok so the Thai facility is ready to produce product?
A. The transfer technology process is still on going. It is our goal to have product from that facility by the end of this year.
(Moderator) We have a question from Brian Davidson with SF Capital Partners. Please go ahead sir!
Q. Hi Dr. George! I might have missed part of this; I apologize if it’s been addressed. The technology that you described today; the change in platform; how does that affect, if at all what your time line is in Thailand?
A. It has no affect on it at all.
Q. Does that mean that you’ll be; you’ll not be using a different platform in Thailand? Or you’re just going to sort of transition it?
A. We will continue to make our assays as they are currently configured, for manufacturing in the facility in Thailand. Those products we can continue to sell into those markets where patents are not blocking our ability to do business. This will continue as; we fully recognize the necessity for getting product into the market and we are committed to do that as rapidly as we can possibly accomplish it. We do not intend to let the Ani acquisition (as important as we believe it is) to in any way change our timelines for getting product into the market from the Thailand facility. We recognize we need to start a revenue stream and that is our number one priority in the Company.
Q. Just so I understand; you anticipate at some point in the future transferring to the Ani platform in Thailand?
A. I think that’s likely. I really don’t want to comment on that right now, but yah, logically I think that that would probably be a reasonable thing to anticipate.
Q. Just so I’m clear again, the comment you made on the prior question about 05 and mid 05 that was with respect to Rockville?
A. Yes.
Q. And with regard to China then, will that also incorporate the new platform?
A. It will not. Again, in China we intend to; we’re just too far down the road in China to make the switch to a new platform. We intend to press forward with all of the energy that we can muster to start the clinical trials in about a week; get it done this year; get the submission into the SFDA in China; get approval and start manufacturing our current format in China as quickly as we can possibly complete the regulatory process.
(Moderator) We have no more questions in the queue at this time Sir so I’ll turn the call back over to you.
Ok ladies and gentlemen, I really appreciate your joining us today. I apologize for the short notice of the Call, it was not intentional, we just had some pressures on us to do this as quickly as we can, but again, I really want to emphasize that this is really a landmark event for Calypte and we look forward to going ahead and focusing our business around the new Ani platform, something that I have wanted ever since I joined the Company, is a platform that is unique and our own platform that we have the freedom to operate anywhere in the world and now we have it. So, we look forward to reporting back to you in the future as we look forward with this and we feel like we’re on our way.
Thank you very much.
End.
Gruß
C.O
sie werden zwar sehr gut ausfallen jedoch sollen sie ein abrutschen des kurses verhindern, wenn sie mit den gruseligen q-zahlen vzw. jahreszahlen zusammen kommen. desweiteren wette ich mit euch, dass ein weiteres 8-k-filing über die ausgabe neuer aktien mit beigeschoben wird.
viel spaß!
There are only 24 days left until the 2 million borrowed from Marr is due.
Only 24 days left before HIV has to file 10K revealing audited results for 2004.
Only 24 days or so before working capital runs out.
Only 24 days before HIV has to deal with financing and "threshold feature" of previous financings.
TicToc Time is running out.......
http://ragingbull.lycos.com/mboard/boards.cgi?board=CYPT&read=66298
willst du direkt wieder auf konfrontation gehen?
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Rec. Time Action Price Volume
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9:35:18 AM Ask 0.32 61000
9:34:40 AM Bid 0.31 75300
9:34:40 AM Ask 0.32 161000
9:34:02 AM Ask 0.31 5000
9:33:50 AM Trade 0.3 3300
9:33:00 AM Ask 0.31 24700
9:33:00 AM Bid 0.3 100000
9:32:58 AM Ask 0.31 5000
9:32:58 AM Bid 0.29 50000
9:30:14 AM Bid 0.28 500
9:30:02 AM Ask 0.44 3000
Simple/rapid tests
Simple/rapid tests (assays) are now available to test for HIV antibodies in blood. Some can be performed in less than 10 minutes. These are called rapid tests. Some require 30 minutes to two hours. These are called simple tests. There are four types of simple/rapid tests: agglutination assays, comb/dipstick assays, flow-through membrane assays, and chromatographic membrane assays.
Simple/rapid tests give results that are as accurate as ELISA tests. In addition, they:
can be done using a whole blood sample or a filter paper (see below) with blood from a finger prick
can be done quickly, enabling people to obtain the results the same day
usually come in a simple kit form and require no special equipment, such as microscopes or electricity
are simple, involving between two and eight steps, reducing the chance of error
can be carried out by staff with limited laboratory training
do not require electricity
are portable and flexible
are easy to read - for most simple/rapid tests, a positive result is indicated by the appearance of a clearly visible dot or line
sometimes have an internal control that ensures that the test result is accurate
are designed either as single tests or in a multiple format for a limited number of specimens, giving greater flexibility than ELISAs in the number of tests that can be performed at one time. This also makes simple and rapid tests more cost-effective if only a few tests are carried out at one time or during a day.
Simple/rapid tests could increase access to HIV testing in areas that lack laboratory services and highly trained technicians. However, simple/rapid tests also have disadvantages. They:
are more expensive than ELISA tests
may require refrigeration (although some can be stored at temperatures of between 2°C and 30°C)
could increase the potential for mandatory testing on the spot
could lead to results being given to people who have not had the chance to think through the implications.
http://www.aidsaction.info/ht/section2.html