NUTRITION 21 Bioaktie?
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Ich wünsche mir/Euch jedenfalls, dass der Grund für die lange Entscheidungsfindung ist: gut (pos.) Ding braucht Weile ;-)
Wir werden sehen!
Gruß S1
extension
by: csareb2 (31/M/Ambler, PA) 06/20/05 04:05 pm
Msg: 14442 of 14445
8-13-2005(?) fda has issued an extension for health claims of chromium picolinate.
Keine Ahnung ob es stimmt... falls ja wäre es nicht so schlimm... bei dem Kurs haben viele schlimmeres befürchtet!
Gruß S1
Ist auch immer eine Frage ob es einem Nerven kostet, oder ob man ganz cool ist; aber wer ist das schon nach diesen Verschiebereien...
Ich werde mich jetzt jedenfalls anderen Dingen als NXXI (z.B. WAPME 549550) widmen... ev. kaufe ich bei pos. Entscheidung...
Gruß S1
Tuesday June 21, 10:00 am ET
PURCHASE, N.Y.--(BUSINESS WIRE)--June 21, 2005--The Food and Drug Administration (FDA) has requested a 60-day extension for the review of Nutrition 21, Inc.'s (Nasdaq: NXXI - News) qualified health claim petition associating chromium picolinate with a reduced risk of insulin resistance, type 2 diabetes and related disease. The petition is based on a compilation of more than 50 scientific studies supporting its safety and efficacy. The company has agreed to the request and is taking measures to facilitate a timely decision. There are a number of other qualified health claim petitions for other nutritional ingredients before the FDA that are experiencing similar delays.
"The implementation of our business strategy does not rely on the outcomes of our petition," said Gail Montgomery, president and CEO of Nutrition 21. "Fortunately, our current advertising and product label claims have performed well in consumer market research and our product distribution will not be limited in any way. Independent of our effort to secure qualified health claims, we will continue to execute our marketing plans to accelerate consumer demand for our chromium picolinate products."
The FDA, in its Consumer Health Information For Better Nutrition Initiative, distinguishes between health claims and drug claims: health claims are not drug claims, but rather statements that can be used on product labeling and packaging that can provide important and timely information to consumers as it relates to dietary choices and disease prevention. Since the filing of the company's health claim petition, the body of peer-reviewed clinical research supporting the safety and efficacy of chromium picolinate has continued to grow.
Earlier this month a clinical study presented by Pennington Biomedical Center at the American Diabetes Association 65th Annual Scientific Sessions in San Diego, CA affirmed chromium picolinate's role as a complementary nutrition therapy that can be used to reduce weight gain associated with a prescription oral anti-diabetic medication. It was also shown to improve insulin sensitivity and blood glucose levels in people with type 2 diabetes.
About Nutrition 21
Nutrition 21 is a nutritional bioscience company and the maker of chromium-based supplements with health benefits substantiated by clinical research. The company markets Chromax chromium picolinate, which is the most-studied form of the essential mineral chromium. Nutrition 21 holds 36 patents for nutrition products and uses, 27 of which are for chromium compounds and their uses. More information is available at www.nutrition21.com.
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Contact:
Nutrition 21
Stacey Antine, MS, RD
914-701-4567
Da läuft einfach folgendes: Das Geld wird rausgezogen um in den nächsten 2 Monaten irgenwo anders damit zu spielen. Viele denken zudem sie könnten zu günstigeren Kursen wieder einsteigen - das war die letzten Male richtig - diesmal könnte es ein Irrtum sein.
Ich sehe nach wie vor gute Chancen für NXXI und bleibe drin.
Die 8 Dollar in 2007 sind immer noch möglich. Hört sich zwar utopisch an, seht euch aber mal den max.Chart an. Das könnte wieder passieren.
Wichtig ist, es gibt keine Ablehnung der FDA. Mehr Daten heißt es wird immer noch geprüft. Das macht man eigentlich nur wenn man eine Entscheidung vorbereitet. Wäre klar, das Zeug taugt nichts, wären die Anträge von NXXI schon vor Moanten abgelehnt worden.
Durchhalten !
NXXI Aktien wieder abzugeben.
Habe mich aber dazu entschlossen , drin zu bleiben , da ich immer noch überzeugt bin das die Nutri enormes potential hat.
Habe schon ziemlich einen grossen Stock , sollten sie aber noch weiter
abfallen werde ich nochmals dazukaufen .
Jetzt haben wir mal die nächsten 6 Wochen wieder Ruhe. Stelle schon mal den Champagner kalt damit ich dann richtig Feiern kann .
Also an alle die noch drin sind --- durchhalten unsere Zeit kommt noch .
Gruss hoelli
Positiv ist, es gibt keine Ablehnung der FDA und die veröffentlichten Studien sind vielversprechend. Der Durchbruch ist eine Frage der Zeit. Die FDA ist aufgrund einiger spektakulärer Flopps in der Vergangenheit ein gebranntes Kind und nun doppelt vorsichtig, d.h. will mehr Daten und Studien. Das ändert jedoch nichts am Grundsatz.
Der Sommer wird interessant bei NXXI. Am 13.8. bin ich aber gerade in Urlaub und nicht am Netz. Ich mache die Augen zu und sehe mir das bei der Rückkehr dann an. Entweder geht es durch die Decke oder wir sind endgültig im Keller. Vermute aber es geht durch die Decke.
New Study Published in Leading Journal Reinforces Safety of Chromax Chromium Picolinate
Friday June 24, 9:00 am ET
Data Supported UK Food Standards Agency Confirmation of Safety
PURCHASE, N.Y.--(BUSINESS WIRE)--June 24, 2005--Nutrition 21, Inc. (NASDAQ: NXXI - News) today announced results of a new study reaffirming the safety of Chromax® chromium picolinate to be published in an upcoming issue of Mutation Research Genetic Toxicology and Environmental Mutagenesis, the leading peer-reviewed genotoxicity journal said. The study is currently available online at http://dx.doi.org/10.1016/j.mrgentox.2005.04.001.
The results found that Chromax did not cause genetic damage in hamster ovary cells. The study was conducted at the request of the United Kingdom (UK) Food Standards Agency (FSA) to repeat a previously published study showing DNA damage. The prior study was not performed under International Conference on Harmonization (ICH) Guidelines and did not use commercially available chromium picolinate.
"When Chromax was tested using internationally accepted guidelines, there was no damage to DNA resulting in gene mutations, even at doses higher than those used in earlier studies," said Ron Slesinski, PhD, DABT, lead research and senior scientist at ENVIRON Health Sciences, and President of the Regulatory & Safety Specialty Section of the Society of Toxicology. "The new findings are consistent with many previous studies showing chromium picolinate is safe."
The body of scientific evidence supporting chromium picolinate's safety includes more than 50 studies, including human clinical trials with more than 2,000 participants, numerous animal studies on thousands of animals, and cellular testing. Chromium picolinate has been recognized as safe by many of the world's leading government and private research institutions including the UK FSA and the Institute of Medicine.
"This study adds to the existing preponderance of human and animal evidence that has for years confirmed that Chromax is safe," said James Komorowski, MS, VP of Technical Services and Scientific Affairs, Nutrition 21. "The results of this study were critical in supporting the UK FSA decision to allow for continued sales of Chromax in the UK." Chromax chromium picolinate received GRAS (Generally Recognized as Safe) affirmation for use in nutritional bars and beverages in June 2002 based on an extensive safety review later published in Food and Chemical Toxicology in 2004.
Chromium is an essential trace mineral critical to proper insulin function and necessary for carbohydrate, fat and protein metabolism. Chromium, which is found naturally in foods in small amounts, is not well absorbed by the body. Chromium, in the form of chromium picolinate, has been used as a supplement ingredient for more than a decade in leading U.S. vitamin brands. An estimated 10 million people consume supplements with chromium each year. Safety research conducted over the past several years has confirmed no significant adverse effects of chromium picolinate when ingested at any dose.
gruesse
seavers
gruss
seavers
Ich werte die neue Studie sogar noch höher da die Frage der Tierversuche und der Auswirkungen auf das Erbgut durch irgendeine alte Untersuchung -die so nicht korrekt war- belastet war. Das Thema ist nun geklärt. Ein OK in UK dürfte eine reglerechte Referenz für die FDA sein. Teile daher den Optimismus auf Sicht der nächsten Monate.
Was soll aber die Diskussion über einen "Reserved Split" bei den Amis ? Das würde beduten, es käme zu einem Umtausch, z.B. 10:1 ( 10 alte Aktien für 1 Neue ). Der Kurs ginge dadurch optisch in die Höhe und das Paier hätte das Image eines Pennystocks los. Offiziell habe ich da noch nicgts gelesen, nur in Forums-Beiträgen.
http://www.cfsan.fda.gov/~rdb/opa-g036.html
Im Moment noch eine Vision, wer weiß aber...
New Study Results Reaffirms Diachrome(R) Significantly Improves Cardiovascular Disease Risk Factors in People with Type 2 Diabetes
Monday July 18, 3:14 pm ET
Results of Clinical Trial Examining Effects of Diachrome on Atherogenic Index of Plasma Presented at 2nd International Symposium on Triglycerides and HDL
NEW YORK--(BUSINESS WIRE)--July 18, 2005-- Nutrition 21, Inc. (Nasdaq: NXXI - News) reported today results from a new clinical study that add to the growing body of clinical data demonstrating that daily supplementation with Diachrome®, a combination of chromium picolinate and biotin, can significantly reduce cardiovascular disease risk factors in people with type 2 diabetes. Findings from the randomized double-blind, placebo-controlled trial, were presented at the 2nd International Symposium on Triglycerides and HDL: Role in Cardiovascular Disease and the Metabolic Syndrome in New York, a meeting organized by the Giovanni Lorenzini Medical Foundation that is attended by both U.S. and international cardiologists and lipid specialists.
The study results presented include an analysis of subjects with type 2 diabetes who were moderately obese and taking oral antidiabetic medications. When Diachrome was added to daily treatment regimens, the atherogenic index of plasma (AIP), a predictive marker for cardiovascular disease that examines triglyceride and HDL cholesterol levels (good cholesterol), was significantly lower compared with the placebo group. The AIP in the Diachrome group dropped from 1.15 to 1.06, while it increased from 1.27 to 1.55 in the placebo group. A significant difference in triglycerides and cholesterol levels was also observed between the groups.
"These results support previous findings that Diachrome can serve as a safe and effective nutritional adjunct to medication in helping to lower triglyceride and cholesterol levels in people with type 2 diabetes," said study investigator Jeffrey Geohas, Medical Director, Chicago Research Center. "The ability for Diachrome to reduce these risk factors is important in this population because heart disease is the leading cause of death in patients who suffer from diabetes," said Dr. Geohas.
Nutrition 21, Inc. conducted the study in collaboration with the Chicago Research Center. "This study underscores the promise of Diachrome in helping to prevent cardiovascular disease in people with type 2 diabetes," said Gail Montgomery, president and CEO of Nutrition 21. "As we share the wealth of clinical data demonstrating the benefits of Diachrome for people with type 2 diabetes, we anticipate that physicians will be eager to incorporate the product into clinical practice."
Diachrome is a nutritional supplement specifically formulated for people with diabetes. It contains 600 mcg of chromium as Chromax® chromium picolinate and 2 mg of biotin. These two compounds are both Generally Recognized as Safe (GRAS) for use as ingredients in food and supplements. It is available for purchase by calling 1-866-DIACHROME or at www.diachrome.com.
About the Atherogenic Index of Plasma
AIP is an index used to measure the atherogenicity of plasma by examining the ratio of triglycerides to HDL cholesterol (good cholesterol). It identifies the risk for atherogenesis (fat build up in the arteries), particularly in diabetes patients and is recognized as a predictor for heart attack. The measurement reflects the delicate balance of metabolic interactions with the whole lipoprotein complex. Physicians currently utilize AIP in clinical practice to quantify response to therapeutic interventions.
About Nutrition 21
Nutrition 21 is a nutritional bioscience company and the maker of chromium-based supplements with health benefits substantiated by clinical research. The company markets Chromax chromium picolinate, which is the most-studied form of the essential mineral chromium. Nutrition 21 also developed Diachrome, which is available through diabetes educators or at www.diachrome.com. Nutrition 21 holds 36 patents for nutrition products and uses, 27 of which are for chromium compounds and their uses. More information is available at www.nutrition21.com.
About Nutrition 21
Nutrition 21 is a nutritional bioscience company and the maker of chromium-based supplements with health benefits substantiated by clinical research. The company markets Chromax chromium picolinate, which is the most-studied form of the essential mineral chromium. Nutrition 21 holds 36 patents for nutrition products and uses, 27 of which are for chromium compounds and their uses. More information is available at www.nutrition21.com.
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Contact:
Nutrition 21
Stacey Antine, MS, RD, 914-701-4567