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يوم الاربعاء 6-9-2006
موعد تصويت على دوائهم من قبل المختصيين...و هي تقريبا مطابق ل fda
يعني يوم الاربعاء راح يكون سعر السهم 50 سنت أو فوق فوق الله أعلم جم يوصل.
الان حركة السهم تحت لعبة الكبار لجمع أكبر عدد ممكن من الأسهم و عند سعر مناسب.
بالتوفيق
يوم الاربعاء 6-9-2006
موعد تصويت على دوائهم من قبل المختصيين...و هي تقريبا مطابق ل fda
يعني يوم الاربعاء راح يكون سعر السهم 50 سنت أو فوق فوق الله أعلم جم يوصل.
الان حركة السهم تحت لعبة الكبار لجمع أكبر عدد ممكن من الأسهم و عند سعر مناسب.
بالتوفيق
راعي العوده
عضو نشط
- التسجيل
- 18 يونيو 2003
- المشاركات
- 320
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رايك بالسهم يا حبيب الكل
رايك بالسهم يا حبيب الكل
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السهم تم توقيفه نقص في البيانات
بس وراه شي اتوقع
Genta's Genasense lacks sufficient data to merit US approval - Bloomberg (0.86 ) : Stock is halted
بس وراه شي اتوقع
Genta's Genasense lacks sufficient data to merit US approval - Bloomberg (0.86 ) : Stock is halted
ابعد
FDA Panel Rejects
Proposed Cancer Drug
By JENNIFER CORBETT DOOREN
September 6, 2006 12:31 p.m.
WASHINGTON -- A Food and Drug Administration panel said Wednesday a proposed leukemia drug by Genta Inc. didn't provide enough benefit to recommend that the agency approve the drug.
The outside panel of medical experts voted 7 to 3 against the proposed drug, Genasense. The panel specifically voted on a question that asked whether the drug demonstrated "substantial evidence of effectiveness." The FDA typically follows its panel's advice but is not required to do so. The agency is expected to make a final decision about Genasense by the end of October.
The Berkeley Heights, N.J., company is seeking FDA approval for its proposed drug, Genasense, to treat chronic lymphocytic leukemia, the most common form of adult leukemia, or blood cancer, in the U.S. The drug would be used in combination with two chemotherapy drugs and in patients who failed previous treatment with another drug.
The main clinical study of the drug showed that while it worked temporarily in some patients, that it did not improve overall survival, or the length of patient's lives.
Loretta Itri, Genta's chief medical officer, explained that Genasense is a drug designed to be used with chemotherapy drugs to enhance the effectiveness of chemotherapy. Genasense is designed to block a protein that's believed to inhibit chemotherapy-induced cell death.
Genta studied the drug in 241 patients, about half of whom received chemotherapy plus Genasense and the other half who received chemotherapy alone. All of the patients had failed treatment with other cancer drugs.
Overall, the study found that 20 out of 120 patients, or 16.7%, receiving Genasense and other therapy temporarily had their disease improve, compared with 8 out of 121, or 6.6%.
Richard Pazdur the FDA's director of the office of oncology products said the findings overall showed that adding Genasense provided a 10% benefit, which was short of the study goal of a 20% benefit. He noted that FDA regulations for approving cancer drugs require a drug to show "substantial" benefit.
In 2004, an FDA panel rejected Genasense as a proposed treatment for advanced melanoma, or skin cancer. The drug is currently being studied as a cancer treatment in other cancers including prostate and lung.
During the panel meeting, Genta representatives noted that for certain patients Genasense helped improve the quality of their lives by temporarily beating back the disease and that for patients who had a so-called complete response it lasted for an average of more than 22 months.
The three panel members who voted in favor of the drug said it should be available and studied further to see who might benefit from the drug.
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13:22 GNTA Genta confirms FDA Advisory Committee Reviews Genasense for Treatment of Chronic Lymphocytic Leukemia (0.87 +0.01) -Update-
Co confirms that a majority of members on the FDA Oncologic Drugs Advisory Committee voted not to recommend approval of Genasense (oblimersen sodium) Injection for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia. While the committee's recommendation is not binding, the FDA will consider this opinion during completion of its ongoing review of the Genasense New Drug Application, which is targeted for October 29, 2006. "While we are disappointed with today's outcome, we strongly believe in the potential of Genasense and what it may offer patients with advanced cancer," said Dr. Raymond P. Warrell Jr., Genta's Chief Executive Officer. "We remain committed to the development of this agent and will continue working with FDA regarding their review of this application." Note that the stock is halted.
13:22 GNTA Genta confirms FDA Advisory Committee Reviews Genasense for Treatment of Chronic Lymphocytic Leukemia (0.87 +0.01) -Update-
Co confirms that a majority of members on the FDA Oncologic Drugs Advisory Committee voted not to recommend approval of Genasense (oblimersen sodium) Injection for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia. While the committee's recommendation is not binding, the FDA will consider this opinion during completion of its ongoing review of the Genasense New Drug Application, which is targeted for October 29, 2006. "While we are disappointed with today's outcome, we strongly believe in the potential of Genasense and what it may offer patients with advanced cancer," said Dr. Raymond P. Warrell Jr., Genta's Chief Executive Officer. "We remain committed to the development of this agent and will continue working with FDA regarding their review of this application." Note that the stock is halted.
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مع الرمي بالرصاص 0.50
مع الرمي بالرصاص 0.50
راعي العوده
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- التسجيل
- 18 يونيو 2003
- المشاركات
- 320
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ايش رايك عمنا يصلح للمضاربه او تركه احسن
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لكن اتوقع ممكن تكون في اخبار جديده عليه قريبا
صح تم الرفض بس الي فهمته انه لازال نجاح او اخبار العلاج الجديد ما انتشر رسمي
لا تدخل الا بوجود شي ايجابي
على فكره السهم اتوقع وقع في فخ فلتر بوهاني مع انه كان مجتاز الفلتر لكن الديون تكاثرت اكيد
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في October 29
اتوقع راح يكون اخر كلام له يا يطير يا يطلقون عليه رصاصه الرحمه
اتوقع راح يكون اخر كلام له يا يطير يا يطلقون عليه رصاصه الرحمه
راعي العوده
عضو نشط
- التسجيل
- 18 يونيو 2003
- المشاركات
- 320
تسلم يا امير
راعي العوده
عضو نشط
- التسجيل
- 18 يونيو 2003
- المشاركات
- 320
الشركة تزل لهم مقال في دورية امريكية عن تجاربهم بالمرحلة الثالثة ما اعتقد انه خبر موثر لمثل هذا الارتفاع وصل 30 %
http://biz.yahoo.com/prnews/060915/nyf030.html?.v=63
http://biz.yahoo.com/prnews/060915/nyf030.html?.v=63
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دورة المؤشرنت للتحليل الفني
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