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NUTRITION 21 INC

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WKN:  890068 ISIN:  US67069V1089
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Mannemer
Was heißt das in der Konsequenz ?
Erstmal ist es keine Ablehung. Zweitens muss es etwas Interessantes geben, sonst präsentiert man das nicht auf wisenschaftlichen Konferenzen. Drittens wird der 17.Juni der Endpunkt in Sachen FDA sein - so oder so. Die eine Formulierung von Montgomery liest sich fast so, als hätte die FDA nicht ausreichende geeignete Ausrüstungen zur Verfügung. Dieses Problem der FDA war ja schon vor einigen Monaten. Ich vermute mal, wir sind jetzt in der Endrunde. Die Dutton-Prognose lautete bis Juli ein Kurs von 1,70 Dollar. Das ist immer noch erreichbar. Da wrden jetzt ettliche aussteigen, das geht an die Nerven und Geduld. Ich bleibe trotzdem drin - sch...egal !
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soyus1
an additional 60-day extension
That's life: PURCHASE, N.Y.--(BUSINESS WIRE)--April 13, 2005--Nutrition 21, Inc. (Nasdaq:NXXI - News) announced today that the results of its Diachrome® clinical trial will be presented at three prestigious scientific conferences in Spring 2005. The study was conducted in collaboration with XL Health, a nationally recognized disease management firm. The 453 patient multi-center trial evaluated the effects of Diachrome, in conjunction with prescription anti-diabetics agents, on glycated hemoglobin (HbA1c), fasting plasma glucose, and cholesterol profiles in people with type 2 diabetes. The scientific conferences are: the American Heart Association's 6th Annual Conference on Arteriosclerosis, Thrombosis and Vascular Biology; the Endocrine Society's 87th Annual Meeting; and the American Diabetes Association 65th Annual Scientific Sessions. ADVERTISEMENT The Diachrome study is the largest U.S. clinical trail to demonstrate the health benefits of chromium-based intervention for diabetes. " This is a major clinical milestone for Diachrome and further confirms its safety and benefits in managing blood sugar and cholesterol levels as an adjunct to pharmaceutical treatments for people with type 2 diabetes," said Gail Montgomery, president and CEO, Nutrition 21. " We look forward to sharing the scientific data in an effort to gain adoption among the medical community of Diachrome for diabetes management." Additionally, Nutrition 21 announces it has agreed to the FDA's request for an additional 60-day extension regarding the company's applications for Qualified Health Claims (QHCs) for chromium picolinate. The FDA's new decision date will be June 17, 2005. The Company applied for QHCs associating chromium picolinate with reduced risk of insulin resistance, type 2 diabetes and related conditions in December 2003. " We understand the current resource constraints at the agency and will continue to cooperate with the FDA to move the process forward," said Montgomery. " The health claims, if approved, will facilitate the Company's marketing of chromium picolinate to healthcare professionals and consumers."
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Nukem
FDA Entscheidung bis Mitte April
Ja, ich seh dass inzwischen auch so. Entweder überzeugt, oder nicht. Diese Woche sollte sich was tun. Es hieß bis spätestens Mitte April wird die FDA Entscheidung erwartet.
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soyus1
Nicht nur Cromax, sondern auch Diachrome :-)
Es gibt auch interessante (News vom 7.4.) Dinge zur Vermarktung von Diachrome (was ja neben Chromax auch vielversprechend ist). Falls der Versuch klappt siehts für den Indischen Markt auch gut aus: Nutrition 21 Partners with Mandan, Hidatsa and Arikara Nation to Combat Epidemic of Type 2 Diabetes Among Tribal Members Thursday April 7, 1:51 pm ET Diachrome(R) Adopted as Adjunct Nutritional Therapy in Physician Supervised Health Outcomes Initiative at Tribal Nation in North Dakota PURCHASE, N.Y. & BISMARCK, N.D.--(BUSINESS WIRE)--April 7, 2005-- Nutrition 21, Inc. (Nasdaq: NXXI - News) and the Mandan, Hidatsa and Arikara (MHA) Nation today announced the initiation of their collaboration to conduct the first Diachrome® Physician Supervised Health Outcomes Initiative among Native Americans living with type 2 diabetes. The program will evaluate the health benefits and costs savings that can be achieved when Diachrome, a patented combination of Chromax® chromium picolinate and biotin specifically formulated for people with type 2 diabetes, is used in clinical practice. The program will include 600 MHA tribal members diagnosed with type 2 diabetes and it will be supervised by Corey Arcelay, MD a physician for the MHA Nation who practices at the Minne-Tohe Health Center in New Town, North Dakota. ADVERTISEMENT "Diachrome supplementation will be added to our existing diabetes treatment program, which includes health education, diet, exercise and anti-diabetic medication," commented Dr. Arcelay. "Diachrome has an excellent safety profile, and the initial clinical results look very promising. A few of our patients have already responded favorably to Diachrome. If these results are confirmed in a broader cross section of our patients over the next four months, then Diachrome will be included in the Indian Health Services formulary stock." "We are pleased to have Nutrition 21 join us in our declared 'War on Diabetes'," said Tex Hall, chairman of the MHA Nation and president of the National Congress of American Indians. "In an effort to combat the devastating effects of this disease on our people, we are always looking for new, cutting edge treatments to add to our existing arsenal of weapons against diabetes. We welcome Diachrome into our MHA diabetes treatment program and look forward to successful results." In 2002 the National Institute of Health reported that approximately 15 percent of American Indians and Alaska Natives who receive care from the Indian Health Service have been diagnosed with diabetes; a total of 105,000 people. On average, American Indians and Alaska Natives are 2.6 times as likely to have diagnosed diabetes as non-Hispanic whites of a similar age and are at increased risk for heart disease, kidney disease, blindness and other diabetes-related complications. According to federal statistics, Native Americans are 420% more likely to die from diabetes than the rest of the United States population. Nutrition 21 plans to expand the Diachrome Physician Supervised Health Outcomes Initiative to include tribal healthcare leaders serving an estimated 38,000 Native Americans on four Indian Reservations in North and South Dakota later this year. "Much like our alliance with XL Health, the MHA partnership allows us to move Diachrome into clinical practice in a public health setting using evidence-based medicine as a model for physician recommendation. Our ultimate business objective is to secure wide scale adoption of Diachrome as a treatment protocol in the management of type 2 diabetes, not just in minority populations in the US, but in affected populations across the globe," said Gail Montgomery, president and CEO of Nutrition 21. Man beachte den letzten Absatz von Montgomery :-) Schönen Gruß & beste Wünsche für eine vermutlich entscheidende Woche Soyus1
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