Calypte Only Company with Full Menu of Tests.

meine Erwartung, verspätet sich oder gar schmälert sich..


Werde meine position bei XKEM aufbauen, ist mitlerweile auch für mich sehr Beobachtungsbedürftig...




http://www.investorshub.com/boards/board.asp?board_id=2819

http://www.ariva.de/quote/profile.m?secu=153359

 

 

http://www.southendstockpickers.com/

 

 

für Calypte gilt China Zulassung als oberstes Priorität...

 

 

 

One Thing To Keep in Mind

The Big Money managers on Wall St are a very close eye on XKEM ! They are looking for OTCBB stocks with huge potential and XKEM is one of them. XKEM has experienced tremendous Money Flow this 3rd Quarter [w/ $31,000,000.00 trading in one day recently, THAT'S HUGE FOR A PENNY STOCK!!!] The Hedge Fund Managers are going to exploit, manipulate and INFLATE XKEM's pps, volume and Money Flow returning >5,000% profit for new buyers under 3cents. The brief 200% spike-up in June for XKEM is only a fraction of what is ABOUT TO TAKE PLACE!!! The 'Shorts' have squeezed Main St Longs who paid 6, 7, 8,9,10 and 11cents and many of those Main St sheep are selling and/or sold recently taking a 70% hair-cut on their investment. XKEM is poised to have the similar rally that PTSC had in Q-1 '06 rising from 7cents to near $2.00 in 3 months time. Folks this XKEM product; NICOSAN/HEMOXIN, which has received United States Food and Drug Administration (FDA)-designated orphan drug status as the first definitive therapy for sickle cell disease (SCD) and it has what it takes to get the Hedge Fund Managers ATTENTION!!! 

 

 

AT SouthEndStockPickers,  we're focusing solely on undervalued Nasdaq stocks that we feel will return potential profits of 500%+ in 1 to 3 weeks.

 We feel this stock pick is very UNDERVALUED!
This Company is a SLEEPING GIANT ready to be AWOKEN.


Stock Alert! = Xechem International Inc.
Ticker Symbol = XKEM.OB
Sector:Healthcare
Industry:Biotechnology
Website = www.xechem.com
Short Term Target Price$2.65
Long Term Target Price$4.25
Disclosure= We Own Shares
Recommendation = MEGA BONUS BUY 

Information To Consider

1.Xechem Chairman, Dr. Ramesh Pandey, to Present NICOSAN(TM) Story at 34th Annual SCDAA Conference in Dallas.

2.Demand for New Sickle Cell Drug NICOSAN(TM) Far Exceeds Supply.

3.There are many theories on that, and it's probably best for me not to address them directly. What I do feel comfortable in saying is that we have something very special going on in Nigeria right now and have unquestionably accomplished a great deal in getting to this point in spite of the many obstacles in our path. I am confident that as we secure one or more traditional bank type financings and move forward in the implementation of our business plan, things will change markedly for Xechem and its shareholders. My message to our shareholders is this: the patient investor will be rewardedas we progress toward full scale production of this historical drug.

ACCUMULATION ACCUMULATION.........is the Key Word

 

wie kannst du in deinem heiligen caly-board werbung für einen anderen titel machen? wer soll dir denn noch glauben, junge?  ...lach...


"...meine Erwartung, verspätet sich oder gar schmälert sich..." ...oder treffen "NIE ein", hast du vergessen aufzuführen...


junge, junge, junge bist du glaubwürdig...
 

 

a report by

C a l y p t e B i o m e d i c a l C o r p o r a t i o n

Calypte Biomedical Corporation has been involved

in the pursuit of novel infectious disease diagnostics

for over a decade. Not content with simply making

Calypte versions of tests that are readily available

from a variety of suppliers, Calypte?s focus is on

developing, manufacturing and distributing tests that

other companies do not or cannot, with a particular

focus on HIV.

Calypte may be best known as the only company to

have developed and achieved US Food and Drug

Administration (FDA) approval for a urine screening

enzyme-linked immunosorbent assay (ELISA) for

HIV-1 antibodies, as well as its corresponding

Western Blot.

The development of HIV antibody assays, which use

non-blood samples, remains a passion of the

company. It is currently launching three rapid tests

for HIV-1/2 antibody, including a rapid urine test

and a rapid oral fluid test.

T h e C a s e f o r A l t e r n a t i v e S a m p l e s

There is broad consensus that testing, coupled with

counselling, is a fundamental and critical aspect to

HIV control. With a few exceptions, such testing

and counselling is voluntary, so the success of such

efforts depends largely on the willingness of the

public to participate; however, for a variety of

reasons, the public may not participate in the

numbers desired. Knowing, for example, that HIV

testing is typically performed on blood samples, the

public may opt out of testing ? even if they know

they may be at risk ? due to fears of pain and safety,

or for cultural reasons.

The ability to perform HIV testing accurately and

safely using both urine or oral fluid samples has been

amply documented, as has the increase in voluntary

testing rates when such alternatives are offered.

T h e C a s e f o r R a p i d H I V

A n t i b o d y T e s t i n g

Rapid, point-of-care (POC) testing for HIV

antibody is appropriate in a variety of settings. It has

been widely noted that substantial numbers of

people who participate in voluntary testing and

counselling programmes and provide samples for

testing, never return for their results. Whether this

occurs due to fear of the outcome, inconvenience

or other reasons, the result is that HIV-infected

people remain undiagnosed and untreated. In the

developing world where the HIV epidemic is most

acute, rapid testing algorithms using multiple rapid

tests in series or parallel have become

commonplace. In addition to the benefit of

immediate referral to treatment, rapid tests can be

performed in the absence of properly equipped

laboratories or skilled laboratorians.

Aware? Rapid HIV Antibody

T e s t i n g w i t h A l t e r n a t e F l u i d s

Calypte?s Aware rapid tests have been designed with

the developing world in mind. Available only in

selected markets, the tests have been designed to offer

optimal accuracy, economy and patient appeal. The

assay test strip is in a dipstick format that is more

economical to manufacture and less expensive for

disposal. Patients are familiar with the dipstick format

from participating in routine urinalysis.

By combining the proven benefits of alternate fluid

sampling with the proven benefits of rapid testing,

Calypte believes that it offers a broader range of rapid

testing options than any other company.

A w a r e T e s t s

Three Aware tests have been developed:

? Aware BSP for use with whole blood, serum,

and plasma;

? Aware OMT for use with oral mucosal transudate

(oral fluid); and

? Aware U for use with urine samples

All three tests are sensitive to both HIV-1 and

HIV-2. Calypte is a duly licensed manufacturer of

HIV-2 rapid tests, so there is no risk that

production will be interrupted in the future for

reasons of HIV-2 patent infringement.

Calypte Biomedical Corporation ?

Innovators in Infectious Disease Testing

1.B U S I N E S S B R I E F I N G : E U R O P E A N P H A R M A C O T H E R A P Y 2 0 06

 

Technology & Services Section

2.B U S I N E S S B R I E F I N G : E U R O P E A N P H A R M A C O T H E R A P Y 2 0 0 6

Each of the three tests takes 20 minutes to perform,

and include a true human immunoglobulin G (IgG)

control line that verifies both that the test device is

working properly and that the appropriate sample

was introduced to the device.

Each of the three tests is sold in kits of 25 or 50 tests

and can be stored and shipped without refrigeration.

Two of the Aware tests (BSP and OMT) require the

use of a buffer solution and this is provided in excess.

The kits include multiple buffer droppers so that

multiple users can use the same test kit

simultaneously. The rapid urine test requires no

buffers or sample preparation ? simply drop a dipstick

into a tube containing urine.

S p e c i a l i t y P r o d u c t s f o r

H I V E p i d e m i o l o g y

The use of widely available HIV antibody tests can

provide useful information about HIV prevalence in

a given population at a given point in time.

However, one of the most vexing problems for HIV

researchers has been the estimation of HIV incidence

? the number of newly acquired infections. Clearly,

two populations with identical prevalence at some

point in time can have dramatically different

incidence rates ? one group may be experiencing a

steady or declining rate of new infections while the

other may be experiencing explosive growth.

An understanding of HIV incidence trends is critical

for many people engaged in HIV control efforts.

Policy makers, financial and resource planners and

programme managers all need to understand the

nature and scope of the HIV epidemic in populations

if they hope to intervene in a timely manner, plan for

the future and determine which programmes are

working and which are not.

Past efforts to estimate HIV incidence have been

based on assay ?detuning?, whereby highly diluted

samples are run on a commercially available HIV-1

enzyme immunoassay (EIA) test, with the

expectation that only those sera associated with longestablished

infections will have a high enough titre to

yield a reactive result. This approach is prone to

reproducibility problems and a sensitivity that is

limited to a small range of HIV subtypes.

The HIV-1 BED Incidence EIA is a microwell EIA

test for use with serum or plasma samples previously

determined to be reactive for HIV antibody.

Originally developed by the US Centers for Disease

Control (CDC), Calypte was licensed to

commercialise the test in 2004. The assay is intended

for surveillance purposes only, to estimate HIV-1

incidence in populations. Since it is not used in the

diagnosis or treatment of individual patients, most

countries permit the import and use of this product

without official registration.

The assay is based on the observation that

following infection, the ratio of HIV-specific

IgG:Total IgG ratio continues to rise. This EIA is

quantitative and includes the standards needed to

validate the assay. A calibrator is also provided that

performs in the assay at the typical HIV-specific

IgG:Total IgG ratio found 5.5 months postinfection

and is used to provide a threshold cutoff

for the classification of recent seroconversion.

Samples with optical densities (ODs) below this

threshold are presumptively considered ?recent?

and must be repeated in triplicate. The reference in

the product?s name to BED relates to the use of a

unique branched multi-subtype gp41 peptide that

incorporates the immunodominant regions from

subtypes B, E and D. This confers upon the assay

with equal sensitivity across types A?F.

F u t u r e D e v e l o p m e n t s i n

I n c i d e n c e T e s t i n g

In collaboration with the US CDC, Calypte is

developing an application that will permit the BED

Incidence EIA to be used with dried blood spots

(DBS) or dried serum spots (DSS) ? a development

that will expand the utility and convenience of the

assay. Dried blood and serum samples are easy to

collect and store and the blood spot application for

BED would permit retrospective analysis of

archived samples that have been collected in this

manner. In addition, routine collection of such

samples can be conveniently integrated into HIV

screening programmes in such a way that blood spot

samples associated with positive HIV antibody

screening results can be set aside for subsequent

incidence testing.

The dried blood spot application for the HIV-1 BED

Incidence EIA will entail the use of an accessory pack

of controls and standards in DBS format, which is

used along with the regular BED test kit.

Commercial availability of the accessory pack is

anticipated late in 2005. ■

 

http://www.touchbriefings.com/cdps/cditem.cfm?cid=5&nid=1890

 

"Commercial availability of the accessory pack is anticipated late in 2005" - Wird für Ende 2005 erwartet...

Aber das Warten sind Caly-Aktionäre ja gewohnt.



Es genügt nicht, keine Gedanken zu haben, man muss auch unfähig sein, sie auszudrücken.  

wie verzweifelt und gestört muß man sein, um erst mal was von XECHEM zu posten und dann wieder einen uralten bericht von caly. du bist wirklich die lachnummer schlechthin hier im board.

das schlimme ist, du merkst nicht mal, wie peinlich du bist...


glaubst du im ernst, dir glaubt hier noch eine sau im board, nachdem was du hier abziehst.

vorschlag: user-ID abmalden. neu an melden unter neuer unser-ID. mehr einsicht und lernfähigkeit zeigen + hoffen, dass du nie mehr als brokerisince alias hans-rosenthal alias xxx erkannt wirst....

oh mann, du armer kerl...  

 

Junge wie gestört muß man sein, um beide Sachen nicht voneinander getrennt zu halten..

 

Ich muß nur dir raten, keine weiteren ID's anzumelden..

 

Meine Meinung zu Xechem ist nach wie vor, dabeizubleiben als investierter und pos. aufzubauen...

 

 

Der Bericht mag alt zu sein, ist aber Aussagefähig.. Der ist von 2005 , du kannst ihn als uralt bezeichnen, für mich können Zulassungsberichte auch uralt erscheinen, nach dem sie dann veröffentlicht werden.....

 

bekommen und ein kleines Update über China und Indien ebenfalls, werweiß vielleicht sogar die Zulassung für China ...  

Ich tippe mal auf Umsätze weit unterhalb von Achmeds Döner-Express von umme Ecke.

Aber positiv sollte sich der Wegfall der Unkosten fürs Amex-Listing bemerkbar machen. *ggg*




Es genügt nicht, keine Gedanken zu haben, man muss auch unfähig sein, sie auszudrücken.  

warum preist du eine andere aktie hier in deinem thread an? da sieht man mal, dass du innerlich schon aufgegeben hast bei caly und nur noch die fahne hochhälst, um anderen deine teile noch irgendwie andrehen zu können.

nach den quartalszahlen rutscht ihr die 0,05$...naja, bei deinem persönlichen break-even von 0,30? bist du dann bald schon 64% im minus und das, owohl du immer wieder "nachkaufst". so gibst dues zumindestens vor. aber das glaubt die eh keiner mehr.

ich denke abe, mit -84% liegst du noch ganz gut. da gibt es andere, deren restkapital liegt gerade noch im einstelligen prozent-bereich bis hin zum promillebereich.

der zukünftige RS wird euch dann den rest geben und eure "glaubwürdigkeit" und "seriösität" endgültig ad absurdum führen.

friese deiner asche, du ober-peinlicher ex-broker. nach dem RS kannst du dich dann wieder umbenennen in "broker-since 1994-until-2007"

selbst schuld. du hast es dir selber zuzuschreiben.  

Position- Long; ST Rating- Strong Buy; LT Rating- Strong Buy

 

Meine Teile werde ich behalten , das kannst du mir glauben..Capitulation kommt nicht in Frage...


Beruhig dich Joelu, es wird schon klappen....  

CBMC.OB 3:51PM ET 0.0650 Down 0.0152 Down 18.95%   763,839



Es genügt nicht, keine Gedanken zu haben, man muss auch unfähig sein, sie auszudrücken.  

http://phx.corporate-ir.net/...MueG1sP2lwYWdlPTQ0Njg2NTcmcmVwbz10ZW5r  

During the third quarter of 2006, we have been in routine contact with the
Chinese State Food and Drug Administration ("SFDA") regarding their review of
our submission of our AwareTM HIV-1/2 oral fluid (OMT) rapid test for approval
and have provided additional or clarifying information as requested. Following
the general review, our submission will be reviewed by an expert panel within
the SFDA at a meeting that we expect to occur in December 2006. We then expect
that our submission will be reviewed by an SFDA leadership panel. We do not know
when this review will occur, however, our current SFDA reviewer has informed us
that since our test employs "new technology," the panels will review it on an
expedited basis. At this time, we do not know whether either the expert or
leadership panel's consideration will result in an immediate recommendation for
approval or a request for more information.

Beijing Marr, our joint venture with an affiliate of Marr Technologies BV, our
largest stockholder, will manage the Chinese oral fluid test product launch.
There are several large markets in China, such as those created by new laws
requiring HIV testing of military recruits and university students as part of
their admissions process, as well as a publicly-announced commitment by the
Chinese government to offer


                                       24




voluntary HIV testing to its entire 1.36 billion person population. With trained
non-professionals and a safe, non-invasive oral fluid test, we expect strong
demand for our initial test.

Beijing Marr has existing manufacturing facilities that have been renovated and
upgraded for the production of our AwareTM HIV-1/2 rapid oral fluid (OMT) test,
and we are implementing procedures to ensure our compliance with the GMP
requirements that we must meet in manufacturing our AwareTM line of HIV-1/2
rapid test products for sale in or export from China. We have manufacturing
equipment and personnel on-site and expect to have the necessary GMP approval in
sufficient time to produce inventory for commercial sales upon SFDA approval of
the OMT rapid test. This facility will also support manufacture of our AwareTM
products for export from China to our other international markets. We are also
evaluating existing products at these facilities although our primary focus is
on our AwareTM HIV-1/2 OMT rapid test.

We have completed the regulatory approval process for our Aware TM HIV-1/2 BSP
test in South Africa, Uganda, Zimbabwe and Kenya and for our Aware TM HIV-1/2
OMT test in South Africa, Uganda and Kenya , providing opportunities for
humanitarian organizations to sponsor our product in their testing programs. The
Mineseeker Foundation ("Mineseeker") has announced plans to use our HIV-1/2
Rapid OMT tests in a program it plans to begin in Sub-Saharan Africa later this
year. We have received an order and cash deposit from an entity working with
Mineseeker and have manufactured approximately 35,000 Aware TM HIV-1/2 OMT tests
which we expect to ship during the fourth quarter of 2006 to their first
location. This shipment is expected to inaugurate Mineseeker's announced program
to test at least one million persons over the next twelve months. We believe
that cooperating with humanitarian organizations to help fight the HIV/AIDS
pandemic in critical areas where we are obtaining regulatory approval,
particularly in South Africa, will be an important trend in 2007 as we seek to
achieve significant sales growth of our Aware(TM) HIV-1/2 rapid OMT test.

Sales are also beginning in the Middle East following the initial approval of an
over-the-counter ("OTC") version of our Aware(TM) HIV-1/2 oral fluid rapid test.
We continue to pursue business opportunities in the Middle East, targeting the
UAE as our first market. We have received an order and cash deposit and have
completed manufacturing 100,000 Aware TM HIV-1/2 OMT rapid tests which we expect
to ship to our distributor in the UAE during the fourth quarter of 2006. Our
distributor has informed us that regulatory approvals are progressing in several
additional countries within the region. We expect that the Middle East will be a
significant market for us in 2007, particularly as we obtain additional
approvals for our unique OTC test product.

During the third quarter of 2006, we received approval for our Aware(TM) HIV-1/2
OMT rapid test for both the professional and OTC markets in the Russian
Federation. The Russian Federation is now the second market, following the UAE,
to approve the use of an HIV-1/2 test in OTC settings, permitting significantly
greater access to HIV testing in these countries. We expect to utilize Marr's
expertise and contacts in the Russian Federation as we establish our
distribution system and our sales and marketing activities in that region. We
have initiated contacts in the private sector, where a number of large
corporations are focusing a portion of their social budgets on the HIV/AIDS
problem in their communities. Russia currently has the fastest growing rate of
increase in HIV/AIDS infection worldwide. We expect significant sales in this
market beginning in early 2007.

In India, we have commenced product evaluations for the military and private
sectors. The process is expected to generate sales in this important region
during 2007. By the end of 2007, we expect to have achieved our initial sales
and marketing milestone - regulatory approvals and distribution networks
consummating sales in the four parts of the world having the greatest HIV/AIDS
prevalence, namely Sub-Saharan Africa and the three regions identified by The
Gates Foundation as comprising the "Next Wave" trend in the AIDS pandemic,
specifically China, India and Russia.

We are in the process of developing additional distribution channels and plan to
conduct additional trials in several African and Asian countries. The clinical
trial and regulatory approval process will be on-going through the remainder of
2006 and beyond. We are primarily targeting countries which have been selected
for funding by PEPFAR, the $15 billion President's Emergency Plan for AIDS
Relief, and currently have


                                       25




representation in more than half of them. Many HIV intervention programs in
developing countries are supported by foreign funding. In the case of funding
from the United States, typically through PEPFAR or USAID, products that are not
approved locally or by the USFDA may be used provided they have a waiver issued
by the USAID and CDC. We have compiled the required data in terms of
"manufacturer's claims" and independent trials for both our OMT and blood, serum
and plasma HIV-1/2 rapid tests. We have recently been notified that our blood,
serum and plasma product has been evaluated and is approved for addition to the
USAID waiver list. We are actively pursuing a USAID waiver for our OMT product
as well. We believe that obtaining a USAID waiver is another important milestone
in facilitating international sales of our rapid tests.

Financial Considerations

Our operating cash burn rate has been trending downward since 2004. The burn
rate for the year ended December 31, 2005 declined to approximately $0.7 million
per month from $1.1 million per month in 2004. Our consolidated operating cash
burn rate for the first nine months of 2006 has averaged less than $0.5 million
per month, including the impact of our Chinese joint venture operations. Our
domestic burn rate decreased primarily as a result of the restructuring of our
business and the discontinuation of our Legacy Business.

During the first nine months of 2006, we incurred a net loss of $11.4 million,
including a charge for $7.1 million in non-cash interest expense primarily
attributable to the accounting for our convertible debt and related derivatives
and the re-pricing of certain warrants. At September 30, 2006, we had a working
capital deficit of $10.7 million and our accumulated deficit was $165.3 million.
Based upon our financial condition at December 31, 2005, which included working
capital and stockholders' deficits of $3.0 million and $7.2 million,
respectively, recurring losses and our accumulated deficit of $154 million, our
independent accountants issued an opinion on our financial statements as of
December 31, 2005 citing substantial doubt about our ability to continue our
business operations as a going concern. During June 2006, we entered into
Subscription Agreements to sell an aggregate of $3 million of our common stock
in a private placement; and have received $495,000 of the subscribed amounts
through November 2, 2006. Between November 2005 and September 2006, we have
issued an aggregate of $5,500,000 of 7% Promissory Notes to Marr, availing
ourselves of the entire amount committed under this facility. As a result of our
July 2006 offer to amend to $0.15 per share the exercise price of warrants
issued in conjunction with our May and July 2004 Private Placements, our April
2005 8% Convertible Notes and our Credit Facility Agreements with Marr for those
warrant holders agreeing to exercise all or a portion of their warrants by July
21, 2006, we received approximately $258,000 in cash proceeds and entered into
agreements with certain warrant holders for the cancellation of our obligations
to repay an aggregate of $959,000 of our 8% Convertible Notes and $2,545,000 of
our 7% Promissory Notes issued under the 2005 Marr Credit Facility in lieu of
cash payments for the warrant exercises. In the absence of additional
conversions, both the 8% Convertible Notes and the 7% Promissory Notes, an
aggregate of approximately $7.9 million including the 8% Interst Notes issued on
October 2006, are due in April 2007. Our current cash resources and commitments
are insufficient to provide us with the liquidity required to fully attain our
business milestones, achieve positive cash flow and meet our obligations when
due. We do not believe that our current cash resources are sufficient to sustain
our operations through 2006 without obtaining additional financing.

Our longer-term liquidity and capital requirements are dependent on constraints
similar to those which impact our current liquidity and capital resource
considerations and which will be critical in validating our business model
during the remainder of 2006 and in 2007. In the absence of adequate resources
from current working capital and existing financing arrangements, we will be
required to raise additional capital to sustain our operations.

 

20.000$ Umsatz(Einkünfte) im Monat - noch mal gedrittelt zum Vorjahr.

Die Kosten und Schulden habe ich mir vorsichshalber gar nicht erst angeguckt.



Es genügt nicht, keine Gedanken zu haben, man muss auch unfähig sein, sie auszudrücken.  

In the absence of adequate resourcesfrom current working capital and existing financing arrangements, we will be required to raise additional capital to sustain our operations.
          §  
Bis über beide Ohren verschuldet, keine nennenswerte Einkünfte auf absehbare Zeit(jetzt sind es schon zwei China-Panels, die entscheiden müssen - sprich vor 2010 läuft da nix und der andere Test scheint keine objektiven Ergebnisse abzuliefern, wird von der UN-Organisation deswegen als nicht brauchbar eingestuft).

Wer soll da noch Kohle reinschießen?




Es genügt nicht, keine Gedanken zu haben, man muss auch unfähig sein, sie auszudrücken.  

Die Afrika und UAE verkäufe nicht enthalten...

Sicherlich sind die momentanen Unstände nicht berauschend , aber die Aussichten sind Riesig...

Our business model and future revenue forecasts call for a significant expansion
of sales in the People's Republic of China as well as in Africa, India and
elsewhere upon successful commercialization of our rapid test products. Should
conditions beyond our control, such as disease outbreaks, natural disasters, war
or political unrest, redirect attention from the worldwide HIV/AIDS epidemic or
concern for other STD's, if and when we are able to develop and introduce such
diagnostic products, our customers' ability to meet their contractual purchase
obligations and/or our ability to supply product internationally for either
evaluation or commercial use may prevent us from achieving the revenues we have
projected. As a result, we may have to seek additional financing beyond that
which we have projected, which may not be available on the timetable required or
on acceptable terms that are not substantially dilutive to our stockholders, or
we may have to curtail our operations, or both.

As a Small Manufacturer of Medical Diagnostic Products, We Are Exposed to
Product Liability and Recall Risks For Which Insurance Coverage is Expensive,
Limited and Potentially Inadequate.

We manufacture medical diagnostic products, which subjects us to risks of
product liability claims or product recalls, particularly in the event of false
positive or false negative reports. A product recall or a successful product
liability claim or claims that exceed our insurance coverage could have a
material adverse effect on us. We maintain a $10,000,000 claims made policy of
product liability insurance. However, product liability insurance is expensive.
In the future we may not be able to obtain coverage on acceptable terms, if at
all. Moreover, our insurance coverage may not adequately protect us from
liability that we incur in connection with clinical trials or sales of our
products.


                                      48
 

China Zulassung keine neuen Höhen..


Das Produkt ist vielversprechend und günstig, Argumente sind da, so das es erfolg haben muß ; )  

verspätungen sind eher ein um so größeres Problem, wo das Management kein einfluss hat..

Zulassungen sind mühesam, Bürokratie drosselt das Verfahren...  

Türen..  

Cash ist kein Problem bei ner Cash Burn Rate von 500.000$ im Monat? Wofür weiß der Himmel - außer dem Management beschäftigen sie doch nur noch nen Hausmeister.



Es genügt nicht, keine Gedanken zu haben, man muss auch unfähig sein, sie auszudrücken.  

 

Beijing Marr has existing manufacturing facilities that have been renovated and
upgraded for the production of our AwareTM HIV-1/2 rapid oral fluid (OMT) test,
and we are implementing procedures to ensure our compliance with the GMP
requirements that we must meet in manufacturing our AwareTM line of HIV-1/2
rapid test products for sale in or export from China. We have manufacturing
equipment and personnel on-site and expect to have the necessary GMP approval in
sufficient time to produce inventory for commercial sales upon SFDA approval of
the OMT rapid test. This facility will also support manufacture of our AwareTM
products for export from China to our other international markets. We are also
evaluating existing products at these facilities although our primary focus is
on our AwareTM HIV-1/2 OMT rapid test.