m*****t
发帖数: 1987 | 1 It dropped 30%. A good buy at dip? |
m*********n
发帖数: 6098 | |
v**********m
发帖数: 5516 | 3 Orexigen® Therapeutics Provides a Regulatory Update on Contrave® NDA
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SAN DIEGO, June 3, 2011 /PRNewswire/ -- Orexigen® Therapeutics, Inc. (Nasdaq: OREX) announced today that it recently met with the Food and Drug Administration (FDA) regarding the New Drug Application for Contrave® (naltrexone HCl/bupropion HCl) extended-release tablets for the treatment of obesity, including weight loss and maintenance of weight loss. Orexigen sought the meeting to gain clarity on the approval deficiency stated in the Complete Response letter the Company received on January 31, 2011. The Complete Response letter requested that the Company conduct a randomized, double-blind, placebo-controlled trial of sufficient size and duration to demonstrate that the risk of major adverse cardiovascular events in overweight and obese subjects treated with Contrave does not adversely affect the drug's benefit-risk profile.
Orexigen submitted a specific proposal to address the theoretical cardiovascular risk cited in the approval deficiency and also explored approval for a narrowed indication in patients with lower cardiovascular risk until data from the proposed outcomes trial could be reviewed for label expansion. The Division of Metabolic and Endocrinologic Products (DMEP) advised Orexigen that the proposed cardiovascular outcomes trial would not adequately address the approval deficiency and instead, requested a pre-approval cardiovascular outcomes trial that Orexigen believes is unprecedented and would generate significantly more information than is necessary or feasible. Additionally, DMEP stated that it would not consider approving Contrave for a narrowed population without first reviewing data from a cardiovascular outcomes trial. Finally, DMEP said that it intends to hold a general advisory committee early next year to discuss cardiovascular assessment for obesity therapeutics, and that any agreement reached on the design of a cardiovascular outcomes trial would be subject to change following DMEP's interpretation of the input received at the 2012 advisory committee.
Based on DMEP's feedback, Orexigen plans to:
* appeal DMEP's responses through the formal dispute resolution process;
* put on hold any further clinical development for its obesity programs in the United States until a clear and feasible path to regulatory approval is identified; and
* accelerate the exploration of opportunities for our product candidates outside of the United States.
"The Orexigen team has been working for the last several months with leading experts in the field of cardiovascular outcome trials to develop and submit a proposal to DMEP that we believe would more than adequately address the question of theoretical CV risk," said Michael Narachi, CEO of Orexigen. "We remain very disappointed in the stance of DMEP and the outcome of the recent meeting. We have serious concerns about the broader implications these actions may have on innovation in the obesity space and the availability of much needed treatment options for obese patients in the U.S."
Since receiving the Complete Response, Orexigen has been evaluating other opportunities where it can leverage its management team, cash and other resources. With the result of this recent meeting, Orexigen plans to advance its evaluation of new opportunities.
Orexigen management will host a call and webcast to discuss this update today at 8:00 a.m. Eastern time. The live call may be accessed by phone by calling (866) 730-5771 (domestic) or (857) 350-1595 (international), participant code 27244834. The webcast can be accessed live on the investor relations section of the Orexigen web site at www.orexigen.com and will be archived for 14 days following the call.
【在 m*****t 的大作中提到】
: It dropped 30%. A good buy at dip?
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m*****t
发帖数: 1987 | 4 互相牵连？
【在 m*********n 的大作中提到】
: VVUS为什么跌？啥新闻
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b*****h
发帖数: 783 | 5 orex 的减肥药基本在放弃得边缘了。FDA一定要orex做心血管安全的clinical。表示
fda很减肥药的心血管安全要求很高。
自然要牵连到vvus。
【在 m*****t 的大作中提到】
: 互相牵连？
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m*****t
发帖数: 1987 | 6 那么OREX在美国基本上是完蛋了？
【在 b*****h 的大作中提到】
: orex 的减肥药基本在放弃得边缘了。FDA一定要orex做心血管安全的clinical。表示
: fda很减肥药的心血管安全要求很高。
: 自然要牵连到vvus。
|
b*****h
发帖数: 783 | 7 前景很不妙。。
【在 m*****t 的大作中提到】
: 那么OREX在美国基本上是完蛋了？
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m*********n
发帖数: 6098 | 8 OREX放弃，如果这样长期对VVUS是利好吧
【在 b*****h 的大作中提到】
: orex 的减肥药基本在放弃得边缘了。FDA一定要orex做心血管安全的clinical。表示
: fda很减肥药的心血管安全要求很高。
: 自然要牵连到vvus。
|
v**********m
发帖数: 5516 | 9 VVUS的毒副作用也不小。
说实在的，大家move on 吧，减肥药今年比较惨淡。
【在 m*********n 的大作中提到】
: OREX放弃，如果这样长期对VVUS是利好吧
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b*****h
发帖数: 783 | 10 耐心等等吧。vvus 还是有机会的。
【在 m*********n 的大作中提到】
: OREX放弃，如果这样长期对VVUS是利好吧
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m*********n
发帖数: 6098 | |
K********g
发帖数: 9389 | 12 今年是癌症药和肝炎药的年份。
【在 b*****h 的大作中提到】
: 耐心等等吧。vvus 还是有机会的。
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H****a
发帖数: 642 | 13 啥 PICK?
【在 K********g 的大作中提到】
: 今年是癌症药和肝炎药的年份。
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w*******d
发帖数: 3714 | |
