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Clinical Studies
Investigational Device Exemption (  812)
§
Clinical studies on human subjects that is conducted within the United States and U.S. territories must comply with Good Clinical Practices regulations. These regulations include Investigation Device Exemption (IDE) under 21 CFR 812, Protection of Human Subjects under 21 CFR 50, and Institutional Review Boards under 21 CFR 56. Guidance on these requirements can be found on the CDRH website at http://www.fda.gov/cdrh/devadvice/ide/index.shtml

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Research conducted outside the United States (814.15)
§
A study conducted under an investigational device exemption (IDE) outside the United States and submitted in support of a PMA must comply with the IDE regulation (21 CFR 812). A study conducted outside the U.S. which was not conducted under an IDE must comply with one of the following:

Research begun on or after effective date November 19, 1986: FDA will accept studies which have been conducted outside the U.S. and begun on or after November 19, 1986, if the data constitute valid scientific evidence (§860.7) and the investigator has conducted the studies in conformance with the "Declaration of Helsinki" or the laws and regulations of the country in which the research was conducted, whichever offers greater protection to the human subjects. If the standards of the country are used, the applicant must state in detail any differences between those standards and the Declaration of Helsinki and explain why the national standards offer greater protection to the human subjects.
Research begun before effective date November 19, 1986: FDA will accept studies which have been conducted outside the U.S. and begun before November 19, 1986, if the agency is satisfied that the data constitute valid scientific evidence (§860.7) and that the rights, safety, and welfare of human subjects have not been violated.
A PMA based solely on foreign clinical data and otherwise meeting the criteria for approval under this part may be approved if:

the foreign data are applicable to the U.S. population and medical practice;
the studies have been performed by clinical investigators of recognized competence; and
the data may be considered valid without the need for an on-site inspection by FDA or, if FDA considers such an inspection to be necessary, FDA can validate the data through an on-site inspection or other appropriate means.
Applicants who seek approval based solely on foreign data are encouraged to meet with FDA officials in a presubmission meeting.

Additional guidance on FDA policy regarding the acceptance of foreign clinical data can be found in the following documents.

Acceptance of Foreign Clinical Studies; Guidance for Industry
http://www.fda.gov/cder/guidance/fstud.htm
http://www.fda.gov/cder/guidance/fstud.pdf

Declaration of Helsinki
http://www.fda.gov/oc/health/helsinki89.html
(World Medical Association’s recommendations to every physician in biomedical research involving human subjects)

http://www.fda.gov/cdrh/devadvice/pma/clinical_studies.html

 

by: sowerharvest



NEWS THAT COULD BE ANNOUNCED ANY DAY:
"... The Calypte HIV 1-2 Blood Rapid Test and our Urine and Blood HIV 1 Western Blot assays were also evaluated as part of this trial but the reports on their performance were not available in time for this Conference Call. We will provide this information as it becomes available over the coming weeks."

EVENTS IN PROGRESS THIS MONTH:
"...Clinical studies have already begun in Vietnam."

"...In addition to China, Vietnam and Africa we are set to begin the regulatory process in India. As we speak Dick Van Maanen our Vice President for Operations is in India working with our distributor to begin those studies."

"...While we’re waiting for the SFDA approval we will be completing manufacturing provisions in China. To that end we are actively recruiting personnel in the areas of quality assurance, quality control, regulatory and manufacturing."

"...A team from Calypte is going to Ani’s facility in Finland for training on the use of this equipment in June and our plans call for the equipment to be installed in our plant in China and for that plant to be ready to service the Chinese market as soon as the SFDA approvals are received."

"...In addition we have started studies in South Africa. Testing of the Blood Rapid Test has been completed and the testing of the Oral Fluid and Urine is scheduled to begin in late June or early July. Testing in Kenya is set to begin in June."

NEXT MONTH:
"...Calypte has been advised by both the CDC and the FDA that an IDE application for use of this test for clinical purposes would be welcomed. Our first meeting with the FDA in pursuit of this claim takes place in July."

LATE SUMMER:
"...Testing in Cameroon and Botswana is ready to go in late summer."

"...Approval (Chinese SFDA) is expected to come in late summer or early fall of 2005."




Gruß

C.O
 

mal gucken, wie lange da einer noch verzweifelt stützt...

die letzten trades:

Time & Sales  
Price Size Time
0.20 600 16:00:32
0.21 800 15:59:14
0.20 67400 15:54:04
0.20 200 15:46:37
0.20 300 15:11:38
0.20 300 13:38:21
0.21 400 12:44:41
0.20 1000 12:09:28
0.21 20000 11:48:45
0.21 25000 11:48:36
0.21 45000 11:35:15
0.20 25000 11:07:39
0.20 10000 11:07:11
0.20 8800 11:07:04
0.20 24700 11:06:54
0.20 2000 11:02:24
0.20 61900 10:50:41
0.20 61900 10:50:37
0.20 5000 10:46:39
0.20 5000 10:44:48
0.20 17500 10:36:10
0.20 6100 10:31:59
0.20 4400 10:31:57
0.21 8000 10:23:07
0.21 8000 10:18:02
0.21 2000 10:15:54
0.20 500 10:04:38
0.20 500 10:04:38
0.20 11000 10:04:37
0.20 4000 09:55:04
 

Support/Resistance
Type Value Conf.
resist. 0.41 2
resist. 0.40 2
resist. 0.33 13
resist. 0.30 7
resist. 0.28 3
resist. 0.27 10
resist. 0.25 3
resist. 0.24 3
resist. 0.23 17
resist. 0.22 8
resist. 0.21 4
resist. 0.20 27


heftigste widerstände bei der 0,20$. wenn die durch ist, seid ihr schnell auf 0,12$.

wer nicht hören will, muß es feste spüren...  

 

by: christianclair1
Long-Term Sentiment: Strong Buy  06/22/05 12:11 pm
Msg: 5022 of 5022

NAIROBI (Reuters) - A group of African clergy infected with HIV is urging the faithful to test for the virus and admit their status to help fight stigma hampering efforts to stem AIDS in the worst-affected continent.

ADVERTISEMENT

Africa is home to 25 million of the world's 38 million people with HIV/AIDS despite accounting for only 10 percent of the global population.

"HIV is a virus, it's not a moral condition," said Anglican vicar Father Jape Heath, who tested HIV positive in May 2000.

"What we're encouraging people to do is to know their HIV status and to know there's no concept of sin attached to HIV," said the 41-year-old South African, a senior figure in the African Network for Religious Leaders Living With And Personally Affected by HIV/AIDS (ANERELA).

The charity was set up in 2002 to encourage greater openness about the virus.

Heath is one of the few Christian priests to openly declare his status since Gideon Byamugisha, an Anglican clergyman from Uganda, became the first more than five years ago.

He was speaking on the sidelines of an ANERELA conference in Nairobi, where clergymen swapped their experiences of being infected with HIV and the discrimination they faced.

"DAMNATION AND PERSECUTION"

Religious leaders are hugely influential across Africa, where millions flock to churches, mosques and temples.

But they have long been guilty of fueling stigma rather than fighting it, U.S. government development arm USAID's senior regional HIV/AIDS adviser Warren Buckingham said.

"Where vision has been articulated by religious leaders, too much of it and for too long has been a vision of judgment and damnation, of punishment and persecution," he was quoted as saying by Kenya's Daily Nation newspaper.

Advised by his bishop, Heath did not inform his congregation until 2002.

"It was one of the most lonely things to be living with a condition like HIV and not to be allowed to speak to anyone about it," he told Reuters.

"It binds you into a place of silence as if there's something so terrible about yourself."

Heath criticized the "ABC" strategy -- Abstinence, Be Faithful and use Condoms -- promoted by many African countries, such as Uganda, to reduce infection rates.

"We see it as very stigmatising because it says to us the only mode of transmission in terms of HIV is sex," he said.

"What does ABC say to the woman who has to make a decision as to whether she's going to breastfeed or bottlefeed? Absolutely nothing. What does it say to the doctor who's determining whether to re-use needles or use a clean one? Absolutely nothing."

Not only does lack of information put Africans at risk of contracting HIV/AIDS, but so does many cultural practices, Zambian Muslim cleric Sheikh Ali Banda said.

He cited the custom of wife inheritance, when widows are passed on to the family of her dead husband, as exposing women to the disease.

"As religious leaders we should understand that it's not a curse, not everyone that is HIV positive is promiscuous, not everyone who is HIV positive is sexually immoral," he said.

Africa's HIV pandemic is one of the main issues leaders of the G8 group of rich nations hope to help tackle at next month's summit in Gleneagles, Scotland.


 

 

zwischenzeitlich gefallen ist....nur so zur info, damit du nicht wieder behauptest, ich würde nur unwahrheiten erzählen...

broker: ich wiederhole mich, damit klardenkende noch aussteigen können...

liebe grüße

euer joelu  

Time & Sales  
Price Size Time
0.21 6000 15:46:26
0.21 2000 15:33:24
0.21 2300 15:33:10
0.21 100 15:14:59
0.21 11500 15:13:41
0.21 9500 15:11:16
0.21 5000 15:06:17
0.20 4000 15:03:16
0.20 6000 14:38:49
0.20 6500 14:37:47
0.20 6500 14:37:47
0.20 1900 14:26:26
0.20 100 14:26:10
0.20 6900 13:42:41
0.20 13500 13:42:22
0.20 13500 13:42:22
0.20 1000 13:42:22
0.20 1100 13:41:58
0.20 13000 13:38:35
0.20 1600 13:09:41
0.20 4900 13:07:50
0.20 700 13:05:00
0.20 2000 12:55:54
0.20 6500 12:52:21
0.20 2500 12:46:11
0.20 10000 12:39:57
0.19 100 12:30:54
0.20 5000 12:26:14
0.20 12500 12:22:55
0.19 3500 12:18:16
 

Im Tagesverlauf interessiert das niemanden. Das hatten wir auch schon mal vor 2 Monaten. Schlußkurs sogar 5% im Plus !


Steh zu Deinen Aussagen wie Du sie gemeint hast und halt Dich nicht an jedem kleinen Halm fest...
Scheinst Dir mit deinen unter 0,20, unter 0,15 ja sogar 0,12 wohl nicht mehr so sicher zu sein, da Du jetzt schon beginnst dich zu rechtfertigen !?

Noch dazu kommt deine Aussage: "Wenn die 0,20 durchbrochen sind, gehts geradeaus runter auf 0,12 ..."
Is klar ;-)  

vom schlußkurs unter 0,20$ habe ich nicht gesprochen, aber kein problem: wenn du dadurch jetzt dein gesicht nicht gegenüber den anderen verlierst und dich dann besser fühlst, dann wegen mir:

sk im juni nochmal unter 0,20$!!!

ich halte mich nicht an strohhalem fest, wohl eher du, der hoffen muß, dass die 0,20 iregenwie halten. geil, bei dem newsflow...P  R  U  S  T!!!!!!!!

und ich bleibe dabei, werden die 0,18$ signifikant gebrochen, geht es runter bis auf 0,12$...  

 

mehr als phrasendrescherei kommt da wohl nicht mehr.

ich weiß junge, deine sturheit ist programm. selbst wenn ihr unter 0,10$ seid, wirst du noch nicht einsehen, dass du auf dem holzweg bist...schon aus prinzip nicht...nein, nie...niemals, NIEMALS, N I E M A L S!!!!!!


muahahahahahaha  

dann wer wohl auch der j.... nicht hier !

Looooooooooooooooooooooool

wenn, wenn, wenn, wenn, wenn, wenn, wenn, wenn, wenn, wenn, wenn, wenn ......  

 
Im Tagesverlauf interessiert das niemanden. Das hatten wir auch schon mal vor 2 Monaten. Schlußkurs sogar 5% im Plus !


Steh zu Deinen Aussagen wie Du sie gemeint hast und halt Dich nicht an jedem kleinen Halm fest...
Scheinst Dir mit deinen unter 0,20, unter 0,15 ja sogar 0,12 wohl nicht mehr so sicher zu sein, da Du jetzt schon beginnst dich zu rechtfertigen !?

Noch dazu kommt deine Aussage: "Wenn die 0,20 durchbrochen sind, gehts geradeaus runter auf 0,12 ..."
Is klar ;-)  
 

Lol  

lol  

lol  

lol  

 

 

 

 
Im Tagesverlauf interessiert das niemanden. Das hatten wir auch schon mal vor 2 Monaten. Schlußkurs sogar 5% im Plus !


Steh zu Deinen Aussagen wie Du sie gemeint hast und halt Dich nicht an jedem kleinen Halm fest...
Scheinst Dir mit deinen unter 0,20, unter 0,15 ja sogar 0,12 wohl nicht mehr so sicher zu sein, da Du jetzt schon beginnst dich zu rechtfertigen !?

Noch dazu kommt deine Aussage: "Wenn die 0,20 durchbrochen sind, gehts geradeaus runter auf 0,12 ..."
Is klar ;-)  

 

beschweren... Vielleicht schaffst Du wieder ne Sperre meiner ID, weil ich immer so gemein und unfair bin ...  

Gut, dass ich mit diesem Problem nicht alline bin ... PRRRRRRRRRRRUUUUUUUUUUUUUSSSSSSSSSSSTTTTTTTTTTTTT