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I believe Calypte is moving to OTCBB sucessfully. it's just a begining.
18:36:08.480 B 4,000 0.2500
18:12:45.725 S 1,000 0.2700
17:15:55.066 B 2,100 0.2900
17:03:42.368 B 1,500 0.3000
16:57:38.140 B 2,300 0.3000
16:57:38.140 B 43,700 0.2900
16:57:38.140 B 4,000 0.2800
16:43:15.328 S 100 0.2700
16:43:04.342 B 100 0.3000
16:41:16.862 B 150,000 0.2700
16:41:16.862 B 800 0.2700
16:40:10.116 B 50,000 0.2500
16:34:49.305 S 24,200 0.2500
16:34:07.800 B 2,000 0.2900
16:31:23.053 S 3,000 0.2500
16:29:22.644 B 10,000 0.2100
16:29:22.644 B 2,000 0.2100
16:29:22.644 B 10,000 0.2000
16:29:22.644 B 300 0.2000
16:14:18.412 B 9,700 0.2000
This is a conference we need to listen. I guess when Aware OMT gets approved in China, Calypte may apply for U.S. FDA approval using Chinese CDC data. It could be a long shot but the data shows promise.
Another development is that CDE report is on the way to SFDA for reviewing late this week.
LCM INSM Report pdf files... Aug 9, 2006
CONFERENCE CALL HIGHLIGHTS by bruzzones2000on YMB California
1. Company received order from the UAE for 100,000 over the counter tests today.
2. The issue of foreclosure is null, as with the exercise of the warrants, the condition was lifted and the exclusion to foreclose based on AMEX listing is no longer effective or possible.
3. Orders are paid for in advance, therefore, all funding received from sales goes toward producing and filling orders.
4. With today's amount in cash, the company can operate two to three months.
5. The company has two agents out seeking financing for the company.
6. They are in negotiation with the individuals involved in the subscription agreement to pay the balance of the agreement. Remedy, in the event of continued breach has not yet been determined.
Capitalizing company: More flexibility on the otcbb to capitalize. Major opportunities blooming for tests. New challenges, subscription agreement (2) to sell 3,000,000 worth of stock. $495,000 has been funded to date. They breached agreement and are working them. Marr agreement, can issue one more policy note for $500,000. During 2006, offered to amend the exercise price for warrants---April 5, 2005 note, agreed to exercise all their warrants. Helped strengthen balance sheet. 25,000,000 shares of stock $258,000 of cash and retired 3.5 million of outstanding date.
7. They are exhibiting at the 16th AIDS Global Conference in Toronto this week.
8. Mineseeker order to be filled in ten to twelve months. They have the ability to fill it through outsourcing, though can do more through the China Plant.
9. Expected sixty to ninety days for plant GMP certification and production in China, pending approval.
10. SFDA states Calypte will be on the docket in October for the Committee decision on approval in China. SFDA is working hard to get it on the docket in September. Development in Chinese market. Chinese market is expected to grow to 12,000,000,000 in 2003 to 150,000,000 2011 On oral rapid test in China, expect to acheive 15% in the market within two years. Sales and marketing program building relationships with key presons in China...opens doors to other over the counter versions of Aware products.
11. Product based on the ANI technology to be applied for and available on the U.S. market in mid to late 2007 for professional use. 2008 for OTC use.
12. Developing other tests for single step use with the CDC
13. India - Indian Market: Underplayed....5.1 million infections, second number to South Africa. 20% annual growth in diagnostic. Military private and government. Evaluations undergoing, expects approval for all those three markets. Only alternative HIV oral rapid test available in India. 15-25 percent of market, w/n 3 years......
14. OTC Market: OTC Market. Company selling test in UAE, received orders for 100,000 units today. Begun process for OTC test in Europe, particularly in Russia. Filed for approval in Russia.......work with Marr for sales
15. Financing does not affect production and sales of product. Customers pay first and the payment is made in advance to the outsource plant.
16. Regional and Professional Markets: Regional and Pro Markets: Markets expected to grow by 10% annual. Focusing on key countries for growth: Begun selling in South Africa, will be aware, first order from Mineseeker, expected 1,000,000 tests over next twelve months, expect 5 million tests annually. Approvals in Kenya, Maylaysia, Zimbabwe, South Africa
17. Blood test approved with USAID, OMT is in application with USAID for Pepfar funding.
18. BED test: 2nd quarter, revised protocal issued by CDC. Test's design and use and interpretation will continue to evolve as experience is gained with use of the test.
19. Continue to trade on AMEX, for now as HIV. Plan to trade on the OTC bulletin board, pink sheets as well.......adverse impact was a surprise of AMEX, will not affect shipments and deadlines. Not focusing on short termed sentiments of where the stock is and at what price. As long as listed, doesn't expect long termed reaction with market place. Will execute on sound business plan envisioned in 2005....
20. Have and are expecting orders.
The report is 9-page long. I have to get a new photobucket account to load the images. The main body text is here. So read accordingly. It is a good re-freshing report. The iPlex users will reach our target by EOY (my personal estimates were 300-400 by 3Q and 500-800 by 4thQ)
I also had lazard's lawyer's opinion on the patent lawsuit a few weeks ago. They were positive on the trial in Nov. I didn't post it to avoid ammunation to bashers.
The CC was out, and I don't have to hold anything back. I will post them tonight or tomorrow when I have time.
Onward and upward.
Lazard Capital Markets, LLC Update on TRCA
TRCA: 2Q06 results, Increlex revenues below our estimates; HOLD
09 Aug 2006 08:42 AM
|--------------------------------------------------------------|
| Tercica (TRCA) |
|--------------------------------------------------------------|
| RATING: HOLD PRICE: $5.19 |
| PRICE TARGET: NM |
|--------------------------------------------------------------|
TRCA: 2Q06 results, Increlex revenues below our estimates; HOLD
Tercica reported 2Q06 Increlex revenues of $166,000, below our $609,000
estimate. Tercica reported an increase of 89 new prescriptions for Increlex
during 2Q06 from 65 patients by 1Q06, which is in line with our estimate of
160 patients on therapy by the end of June (most of the 89 patients may have
been ex-U.S.) Lower revenues may be the result of reimbursement delays and a
slower ramp up to higher doses.
Increlex run rate of adding approximately 25-30 patients since launch
(Feb-June) matches Iplex’s 28 patients in June but demand for Iplex may be
stronger than Increlex as Insmed reported 500+ patients having been
identified in the U.S. as potential candidates for Iplex therapy. This
compares to 260-270 patients identified for Increlex. For one month (June)
Iplex generated more revenue than Increlex for all of 2Q06 ($180,000 vs.
$166,000) though a majority of Iplex revenue was ex-U.S. Still, we are
impressed with the demand for Iplex.
We reduced our 2006 Increlex revenues to $1.8 million from $3.7 million,
based on 1H06 revenues coming in below our estimates. A manufacturing lot
failure for Increlex during 2Q06 did not impose a supply constraint.
Slow enrollment for MS301. Study MS301 in idiopathic short stature has
surpassed the halfway mark with 57% of patients enrolled (77/135). Tercica
dosed its first patient for MS301 in October 2004 and plans to complete
enrollment by mid-2007. Results from MS301 will allow for growth rate
comparisons between Increlex and higher doses of growth hormone therapy in a
broader patient population than indicated in Increlex’s current label, but
ped/endos appear willing to try both Increlex and Iplex already, as per our
April 2006 LCM Access survey. For once-daily Increlex in study MS308, we
expect complete enrollment by 1Q07 but daily doses of 120µg/kg (to children
<-2 SD in height) may not provide enough IGF-1 to increase growth rates.
Increlex is still under review in Europe with the MAA; we expect a formal
approval in early 2007.
We maintain our HOLD rating and remain cautious, given that the launch of
Increlex will likely be impacted by Iplex, placing one half of Tercica’s
revenues at risk. Somatuline Autogel is still under FDA review and will
compete against a similar once-monthly dosed product with first-mover
advantage, although Somatuline’s injection may provide favorable attributes
(subq versus IM injection, smaller volume of dose, smaller needle).
Upcoming INSM/TRCA milestones
(Embedded image moved to file: pic24855.jpg)
(See attached file: LCM-TRCA 2Q06 results.pdf)
-----------------------------------------------------
Biotechnology Equity Research
Lazard Capital Markets, LLC
30 Rockefeller Plaza
New York, NY 10020
Lazard Capital Markets, LLC Update on INSM!
INSM: 2Q06 results, Iplex posts positive first quarter of sales; BUY
Subject: INSM: 2Q06 results, Iplex posts positive first quarter of sales; BUY
09 Aug 2006 08:57 AM
INSM: 2Q06 results, Iplex posts positive first quarter of sales; BUY
We view the launch of Iplex as promising at this stage and on track to reach
our goal of approximately 400 patients on therapy by YE06. Demand for Iplex
is strong for short stature, particularly in the face of Increlex’s launch,
as management reported 500+ patients having been identified in the U.S. as
potential candidates for Iplex therapy. This compares to 260-270 patients
identified for Increlex. Patients identified for Iplex include both on label
(for severe primary IGF-1 deficiency) as well as for off-label use (less
severe IGF-1 deficiency) in patients currently receiving but not responding
well to growth hormone.
Insmed began shipping Iplex on May 25 so 2Q06 approximated only one month
(June) of Iplex sales. As a reminder, we did not model sales for 2Q06 with
the launch of Iplex taking place so late in the quarter. Most of the 2Q06
Iplex revenue ($172,000 of $180,000) was ex-U.S. from patients receiving
therapy prior to approval. Still, during one month, Iplex revenues surpassed
Increlex 2Q06 revenues of $166,000.
Insmed reiterated guidance of cash operating expense of ($45-48 M) net of
Iplex revenues and that cash on hand of $48 M is sufficient to fund
operations through 1H07. Our 2006 Iplex revenue estimate of $2.6M remains.
Catalysts: Top-line results in HIV-associated Adipose Redistribution
Syndrome at IDSA in October 12-15, 2006.
Risks include a slower-than-expected launch of Iplex and/or a permanent
injunction; however, we see the patent litigation as less of a risk based on
a worst-case scenario for Insmed where the company is found liable for
infringement in November but would be required to pay only a modest (5%-10%)
royalty to Tercica.
Maintain BUY and 12-month $4 target, which derives from a multiple of 6 times
projected 2008 Iplex sales of $119M, discounted 1.5 years at 20%, including
fully diluted shares of 120 million.
Upcoming Milestones
(Embedded image moved to file: pic19855.jpg)
(See attached file: LCM INSM 2Q results.pdf)
-----------------------------------------------------
Biotechnology Equity Research
Lazard Capital Markets, LLC
30 Rockefeller Plaza
New York, NY 10020
I will upload pdf format later tonight!
hallelujah!
Please don't abuse the board. You surely can ask any question you want, however, repeating the same questions over and over is paranoid. If no one can answer your question or does not want to answer your question, you may take them to the company. There is no company's insider here and everyone's answer to your question is speculation and personal opinion. You always manipulate the answer in your favor and attack the person who gives you honest answer. You keep asking why why why and want to have a firm answer like the CEO. If you enjoy someone saying this company is going to BK, then I can make you happy saying "Yes, Sir. Calypte is in BK right now, the pps is zeroooooo now". Are you happy?
I know you are sideline sitter and want to get in at lower price. But your attitude is terrible and disgusting. Please respect the board and respect yourself. Stop repeating your questions. Everyone has already known them, and we are "so stupid" that we cannot answer you.
You are a good trader. You know how to read level 2.
The number is good. One month and 6 days sales was better than expected. I haven't listened CC yet, but just look at PR and I guess the 3Q will be much much better than this. My perosnal experience is the enrollment to iPlex takes very long than normal...3-4 months for an endo appointment, 1-2 two month waitng for insurance approval, 2 weeks lab testing...the total of time to get onto iPlex program requires 6 months at least.
Thanks to everyone to make this board great.
All is well.
CSCO CC out. Great for CIEN. BUY!
Earning out. Good number.
CSCO and NT could buyout CIEN?
Getting interesting now.
http://biz.yahoo.com/ap/060808/ciena_lawsuit.html?.v=1
Hehe.
SHAKIRA LYRICS
"Hips Don't Lie"
(feat. Wyclef Jean)
Ladies up in here tonight
No fighting, no fighting
We got the refugees up in here
No fighting, no fighting
Shakira, Shakira
I never really knew that she could dance like this
She makes a man wants to speak Spanish
Como se llama (si), bonita (si), mi casa (si, Shakira Shakira), su casa
Shakira, Shakira
Oh baby when you talk like that
You make a woman go mad
So be wise and keep on
Reading the signs of my body
And I'm on tonight
You know my hips don't lie
And I'm starting to feel it's right
All the attraction, the tension
Don't you see baby, this is perfection
Hey Girl, I can see your body moving
And it's driving me crazy
And I didn't have the slightest idea
Until I saw you dancing
And when you walk up on the dance floor
Nobody cannot ignore the way you move your body, girl
And everything so unexpected - the way you right and left it
So you can keep on shaking it
I never really knew that she could dance like this
She makes a man want to speak Spanish
Como se llama (si), bonita (si), mi casa (si, Shakira Shakira), su casa
Shakira, Shakira
Oh baby when you talk like that
You make a woman go mad
So be wise and keep on
Reading the signs of my body
And I'm on tonight
You know my hips don't lie
And I am starting to feel you boy
Come on lets go, real slow
Don't you see baby asi es perfecto
Oh I know I am on tonight my hips don't lie
And I am starting to feel it's right
All the attraction, the tension
Don't you see baby, this is perfection
Shakira, Shakira
Oh boy, I can see your body moving
Half animal, half man
I don't, don't really know what I'm doing
But you seem to have a plan
My will and self restraint
Have come to fail now, fail now
See, I am doing what I can, but I can't so you know
That's a bit too hard to explain
Baila en la calle de noche
Baila en la calle de día
Baila en la calle de noche
Baila en la calle de día
I never really knew that she could dance like this
She makes a man want to speak Spanish
Como se llama (si), bonita (si), mi casa (si, Shakira Shakira), su casa
Shakira, Shakira
Oh baby when you talk like that
You know you got me hypnotized
So be wise and keep on
Reading the signs of my body
Senorita, feel the conga, let me see you move like you come from Colombia
Mira en Barranquilla se baila así, say it!
Mira en Barranquilla se baila así
Yeah
She's so sexy every man's fantasy a refugee like me back with the Fugees from a 3rd world country
I go back like when 'pac carried crates for Humpty Humpty
I need a whole club dizzy
Why the CIA wanna watch us?
Colombians and Haitians
I ain't guilty, it's a musical transaction
No more do we snatch ropes
Refugees run the seas 'cause we own our own boats
I'm on tonight, my hips don't lie
And I'm starting to feel you boy
Come on let's go, real slow
Baby, like this is perfecto
Oh, you know I am on tonight and my hips don't lie
And I am starting to feel it's right
The attraction, the tension
Baby, like this is perfection
No fighting
No fighting
One more day...Patience <EOM>.
All is well.
A good website to do research
http://www.aids-china.com/
If you click on shopping tab, you will see some HIV rapid blood testing kit on sale. In China, you can buy all approved hiv rapid blood testing kit in a local drug store or buy it online (price is vary). One unit of cheaper rapid blood testing kit is about 100 RMB (Chinese currency) or $12 U.S. Abbott determine HIV blood test sells 130 RMB (or $16 U.S. dollar) per unit. The website shows all the pricing info.
There are also aids news on the website that are very interesting.
bloodhound99 has questioned about OTC blood testing kits in China. This is a good site for him to do his DD-work.
By the way, I want to mention Orasure Oral hiv-1 testing kit which was approved by our FDA. If you go to Orasure website and check their worldwide sales offices, they do not sell any hiv blood or oral testing devices in China. Why? Because their products are only for testing HIV type-1 not type-2. Calypte's Aware OMT is for HIV 1+2.
bloodhound99, your technics are clever. The only info you are looking for will come from Calypte filings and PRs. I cannot and will not stop you posting anything against the company, and I really don't care what you say. If you think you can sway other's minds, then keep doing it. The truth is truth no matter how you twist it.
Have a good day!
I need your email address turned on in your profile or drop a word in my email box.
Guten Tag to you too and Guten Morgen to you.
And Hallo runcaly
möchte Dich ganz herzlich hier in der ihub begrüßen.
Ek dank auk schoin
Well said cal_pn. You said exact the same I wanted to say but you said much better than me. My main focus now is SFDA approval. The timing is the far most important factor on this. I will work with my Chinese friend tomorrow to translate more from SFDA's website.
However, some of hard fact findings will be kept for true Calypte's investors only. I will not post every single detail here to give bashers free lunch. If any long wants to have my findings, you may email me your eamil address or turn on your profile's email address. After verification, you will receive what we find from inside of China and you can time the trading to make profits. It's public info on Chinese website and my CIA (Chinese In America) friend knows how.
Get to mow the lawn. Have a great weekend!
There are two types of bashers on this board.
The first type of basher is short seller. They short stock and hope to cover at lower price. They don’t post on the board much (or never) because most of them are professional hedge fund investors. They let stock price speak out for them. The short seller is good for a stock. They provide liquidity and support price when they cover. I love hedge fund short sellers.
The second type of bashers is sideline sitter who wants to jump in but their legs are shaky. They bash and bash the stock to try to drive the price lower so that they can buy at the bottom. Most of them are idiots who don’t know or are lazy to do any DD. They hope to buy at the bottom and sell at the top. They are paranoid. They have no credibility at all. After buying a stock at the lower price, they will give themselves new allies and start to pump the stock. bloodhound/reads and sellhigh are the second type of basher. They are mosquitoes. You want to squash them all.
The second typy of posters also try to get a long poster upset to steal more info from him. They use “posting illegal inside info” to let the poster defend himself to reveal where the info comes from. They tried to scare me by saying I posted inside info on the board.
So what? I have a lot of inside information on this stock inside of China. My CIA agent knows the details more than the CEO of Calypte. Why not sellhigh report me to SEC…LOL I am waiting at my door so that I know who he really is. Of course, he wants to upset me so that I can tell him more about the details….lol...forget it.
For the benefits of the majority of board members I will reveal all the details over time. I will put my money in to support the stock price. They want to get the stock lower, then good luck. When this poppy shoots to 1.00 – 1.30, I will sell all my shares to them and sellhigh/reads will buy at “buyhigh”….lol
Federal Republic of Germany.
Studied in Japan and Hong Kong for 7 years. Stayed in singapore and England for 2 years.
I waste too many posts here.
Everyone has a good weekend.
OK, bloodhound..I tell you what CIA stands for...
CIA = Chinese In America
If you know how to read SFDA website in Chinese, you sure know what is going on with Aware OMT approval inside of SFDA. It is public info for all Chinese. It is just like FDA.gov for all Americans. When my CIA friend is over my house this weekend, I will ask him to explain to the board.
Home-do-yourself-testing-kits? Are you saying Calypte has applied for OTC stateus with their rapid Oral test YES OR NO Coinstarz?
You surely don't know how to read...Users can buy the products from drug stores and do the test at home. It has nothing to do w/ OTC. Every approved HIV testing (11 approved blood testing kits) device can be bought at any drug store without prescription. In China, there is no such OTC at all. China has 11 approved blood testing kits and you can buy one and test it at home. But you must have some special eqpt to do the blood test. None of these has OTC attached to the product. China is diff from U.S. Please stop your OTC bashing.
This is the last chance for Calypte/Marr/Gale to write off losses as much as possible and book a huge losses so that they will kick off 3Q earning CC with SFDA approval. Gale's CEO job started on Aug 1st. He will show his performance in 3 Q.
Let the worst behind you and go forward to win the war. Calypte lost a few battles, but they will win the war. The coalition force is strong. Marr + SFDA + YaoHua will take this stock to a higher ground.
yes, I know he is. He can run but cannot hide. The writing style is the same.
Am I your free analyst? Why not ask your broker? In which post I said Calypte had applied for OTC approval in China. Do not put your words in my mouth.
BTW give us your take on the just released second quarters "earnings" report. All those approvals and sales drop from $ 91,000 first
If you don't know how to read the PR, then find someone to teach you. It's not my job to educate you unless you pay the education fee...LOL
Keep bashing...that bid is up....
Are you blind? Which my post has been deleted?
Sometime I like to teasing basher-minded posters....lol...I find out they are so Incompetence doing their own DD on the web and just keep barking. Oh, I forget....they are short-sellers...that is diff...
I know someone like you or sellhigh will question the term of "CIA"....lol..actually I am waiting your response....lol
Take a guess!
How do I calculate the 120 days?
I just saw someone who keeps counting days without knowing how to count working days lol (on purpose?)
CDE officially accepted Calypte/Marr NDA on Feb 28th, 2006, and the reviewing clock went off on Feb 28th 5:00 PM
There was a national holiday (international labor day) from May 1st to May 7th in China. Another holiday was July 1st (switch to July 3rd Monday). So there are a total of 6 holidays between Feb 28th to date. Chinese Gov works 5 days a week. Now, re-count how many working days from Feb 28th to date (Feb 28th should not be included)...Get it?
If you want to see what national holidays are, you may go to www.sfda.org.cn (english version) to find it out as well as other gov websites.
Today is the 108th day. Twevel (12) working days are left.
[edit] I will tell you more in depth this weekend and next week when my best CIA friend coming over to my home and join me to post on this board.
This is a buying oppt (IMO). The Q earning has nothing to do with this stcok performance. We know Calypte is in deep debt and loss money Q after Q. But there is a big catch...Aware HIV 1/2 OMT is real...is being approved by China FDA...
Read this article...
Calypte AWARE HIV-1/2 OMT antibody test using oral fluid: special challenges of rapid HIV testing in the developing world.
2006 Mar;6(2):139-44.
Gottfried TD, Mink RW, Phanuphak P.
Technology Consultant, Orinda, CA 94563, USA.
The testing and counseling of persons at risk for infection with HIV and their subsequent treatment remains the primary tool to curb worldwide transmission of the virus. Rapid HIV tests address the need in the developing world for accurate, easy-to-use tests that do not require laboratory equipment or highly trained professionals for implementation or refrigeration for storage. Calypte Biomedical has recently developed the Calypte AWARE HIV-1/2 OMT antibody test using oral fluid samples. This test has demonstrated high sensitivity and specificity for specimens collected in target areas where increased testing is needed. The inexpensive dipstick format in combination with the use of an alternative fluid to blood provides an improved testing procedure for areas with limited resources.
Strong up-swing. Nice!
Due to recent technical issues with the site...any post under my screen name will be removed automatically after 10 minutes. Cut and save my posts to your hard drive.....just kidding.
Only those worthless posts were removed including some of my posts. you don't miss anything. Enjoy.
Chinese CDE evaluates a HIV blood/fluid testing kit using similar U.S. FDA protocol/guideline. They evaluate clinical performance, sensitivity, specificity, accuracy, storage, and labeling. The agency uses NCCLS EP05-A, EP06-A, EP07-A, EP09-A2, and EP17-P as approval guideline. Now, let’s see how Calypte’s Aware OMT is doing under the guideline.
1. Clinical Performance
The overall clinical performance of total of 1740 OMT specimens was 99.9% based on Calypte all sites combined tests. The minimum requirement for a HIV testing kit is 99.3% by CDE. Calypte’s overall clinical performance passed this criteria.
2. Sensitivity
Sensitivity is a measure of the number of infected subjects correctly identified as positive. The sensitivity of Calypte’s Aware OTM is 100%. The minimum requirement for the Sensitivity is 99.6% by CDE. Aware’s Sensitivity passed this criteria.
3. Specificity
Specificity is a measure of the number of uninfected subjects correctly identified as negative. The specificity of Calypte’s Aware OTM is 99.8%. The minimum requirement for the specificity is 99.6% by CDE. Aware’s specificity passed this criteria.
4. Accuracy
Accuracy is a composite measure of how many of the test subjects were correctly classified as infected or uninfected. Aware OMT accuracy is 99.9%. The minimum requirement for the accuracy is 99.6% by CDE. Aware’s accuracy passed this criteria.
5. Storage
Aware OMT shall be storied in the temperature 2C – 30C (normal room temp avoid direct sunlight)
6. Labeling
Aware OMT labeling is clear and easy to follow.
Calypte’s Aware HIV-1/2 OMT(oral) passed and exceeded all CDE requirements for approval. Calypte’s Aware HIV-1/2 OMT(oral) is a rapid testing method to diagnose HIV positive. It requires 20 minutes only and easy to use. If a user is tested a HIV positive, he/she may have to use a professional blood testing method to confirm in a professional lab.
CED’s Department 5 has evaluated Marr/Calypte’s application. They have not required any additional information from Marr/Calypte regarding this matter. Today (Aug 3rd) is 107 working day. Until 120-working-day or Aug 22nd, CDE will send a written report to SFDA for final approval.
If one exercises his/her basic common sense, he/she will believe the SFDA approval is imminent.
Oral Fluid Anti-human Immunodeficiency Virus(HIV1+2) Antibody diagnostic Kit (Colloidal Gold Device) (aka Calypte Aware HIV-1/2 OMT Rapid Test device) is the official English name used for SFDA approval. You may use this name if you search Chinese website.
Beijing Marr Bio (See pics in I-box) has hired 30 some new employees at its renovated facility since June. They currently have 80+ employees. However, each employee only makes 1/8-1/12th of average American salary. (We all know why Wal-mart loves China…lol)
Also, Marr/Calypte paid $2,500 (or Chinese RMB 20,000) application fee to SFDA on March 15, 2006. A clinic report prepared by CDC was send to SFDA in the same month.
Calypte has done the same process for its urine testing kit to SFDA in 2002. The urine testing kit is for HIV 1 only but SFDA requires for HIV 1+2. The application was approved for HIV 1 only but cannot be sold on the market since it must meet HIV 2 requirement. Calypte will work on it after Oral Aware HIV1+2 gets approved.
Orasure (?) oral testing device is for HIV 1 only. U.S. FDA approved it but it cannot be applied in China because it cannot be used to detect HIV 2. My point is Calypte Oral Aware HIV1/2 is the only one in the world that SFDA is reviewing and is to approve it soon.
From technical stand point of view, Aware OMT passed all the CDE’s requirements. From political stand point of view, Chinese government needs to bring more reliable and quick safe cheap hiv testing method to its people to save the country’s reputation. And here Calypte’s Aware OMT comes……
Watch TWX. Perfect short-term-trading stock, buy or short. All makes money. Where Icahn? LOL
It's Okay that All my posts are being removed and subject to review. I don't have too much time to post during the trading hour. I will compose details about how CDE reviews and evaluates HIV testing device in general and how Calypte' Aware is doing under the CDE's microscope. We all saw the trial data and so did CDE.
Stay tuned...Be back tonight when the family goes to bed.
Trading CIEN starts now and going into earning call. Any opinion?
Strong Buy!