b*****h
发帖数: 783 | 1 呵呵, 过去的几个月obesity drug 起起落落，都搞的疲劳了，但是战斗还没有结束。
现在两个本来稍微领先的基本尘埃已定，剩下的就是OREX了。
OREX 的效果和副作用都处于ARNA 和 VVUS的中间。所以，还是有一定猜想空间的。
VVUS的CRL 对OREX有一定影响，如果是个dip，那是一个比较不错的进入时机。 |
b*****h
发帖数: 783 | 2 vvus CRL 出来了。。关注明天的orex。。 |
a****g
发帖数: 8131 | 3 锯了
orex什么时候会被review？
【在 b*****h 的大作中提到】
: vvus CRL 出来了。。关注明天的orex。。
|
b*****h
发帖数: 783 | 4 12／7 panel ..
【在 a****g 的大作中提到】
: 锯了
: orex什么时候会被review？
|
K**********r
发帖数: 2640 | 5 肯定也死菜，也就玩玩pre-run, 如果有的话。
【在 b*****h 的大作中提到】
: 12／7 panel ..
|
a****g
发帖数: 8131 | 6 我们明天一起烧ree吧
这个垃圾飙了很久，我早就看他不顺眼了
【在 K**********r 的大作中提到】
: 肯定也死菜，也就玩玩pre-run, 如果有的话。
|
y*****l
发帖数: 5997 | 7 热，你们先给我们培训一下怎么烧吧。
【在 a****g 的大作中提到】
: 我们明天一起烧ree吧
: 这个垃圾飙了很久，我早就看他不顺眼了
|
n**2
发帖数: 630 | 8 借股，烧，回填。
我又一次肥手指了，结果超卖了，账面上股数是负的，然后就发现可以这样做。
【在 y*****l 的大作中提到】
: 热，你们先给我们培训一下怎么烧吧。
|
n**2
发帖数: 630 | 9 今年所有的obesity drug都没戏。明年6-8月份再看吧。 |
p********e
发帖数: 1960 | |
|
|
y*****l
发帖数: 5997 | 11 盘前到8块了？！
FDA Rejects Vivus Inc.'s Obesity Drug Qnexa
Thursday 10/28/2010 9:18 PM ET - Dow Jones News
Related Companies
Symbol Last %Chg
ARNA 1.59 0.00%
VVUS 6.13 0.00%
As of 4:00 PM ET 10/28/10
By Jennifer Corbett Dooren
Of DOW JONES NEWSWIRES
WASHINGTON (Dow Jones)--The Food and Drug Administration rejected Vivus Inc.
's (VVUS) obesity drug Qnexa, the company said Thursday.
The rejection marks the second time in less than a week that the agency has
refused to sign off on a drug to treat obesity. Arena Pharmaceuticals Inc. (
ARNA) and Eisai Co.'s (ESALY, 4523.TO) weight-loss drug, lorcaserin, was
rejected last week.
Vivus said the FDA issued a so-called "complete response letter" for Qnexa
saying it couldn't approve the drug application in its current form. The
agency asked the company for a comprehensive assessment of Qnexa's potential
to cause birth defects and to provide evidence that the product doesn't
increase the risk for major adverse cardiovascular events.
The company said the FDA didn't request a new clinical trial, but asked for
two-year study results involving Qnexa to be submitted. At the time the new
drug application for Qnexa was submitted earlier this year, one-year data
were submitted. Two-year study results were released last month.
"We remain confident in the efficacy and safety profile of Qnexa
demonstrated in the clinical development program and look forward to
continue working with the FDA towards the approval for the treatment of
obesity," Leland Wilson, chief executive officer of Vivus, said in a
statement. "We are preparing a comprehensive response to the CRL for
submission to the FDA in approximately six weeks."
Vivus cautioned while no additional studies were requested, the company said
"in the event that any of the FDA concerns are not alleviated, additional
clinical studies may be required."
FDA's decision wasn't a surprise. In July an FDA advisory panel voted 10-to-
6 against recommending the agency approve the drug on concerns that
potential safety issues could be magnified if it is used by millions of
patients.
During the meeting, the FDA said Qnexa resulted in "significant" weight loss
, but raised questions about the drug's long-term side effects, including
birth defects, depression and an unknown impact on the heart. Some patients
in clinical studies had an increase in heart rate.
Many panel members said they wanted to see more safety data before voting to
approve the drug rather than facing potential questions after the drug is
approved.
The development of obesity compounds has been a tough area for companies
since the fen-phen drug combination was taken off the U.S. market in 1997
after one of the medication's components was linked to heart-valve damage.
Abbott Laboratories (ABT) removed its weight-loss drug Meridia from markets
in the U.S., Australia and Canada earlier this month, after regulators
expressed concern over the drug's risk of side effects like heart attack and
stroke.
Qnexa is a controlled-release formulation that combines low doses of two
older drugs: the stimulant phentermine, which cuts appetite, and topiramate,
which increases the sense of feeling full. Topiramate is sold under the
brand name Topamax by Johnson & Johnson (JNJ) to treat migraines and
seizures.
One more obesity treatment is pending an FDA decision. Orexigen Therapeutics
Inc.'s (OREX) Contrave faces an FDA panel in December with an agency
decision due in January.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.
c*****[email protected]
Click here to go to Dow Jones NewsPlus, a web front page of today's most
important business and market news, analysis and commentary: http://www.djnewsplus.com/nae/al?rnd=qtnM4rRvpcD8sJE6cGFHbg%3D%3D. You can use this link on the day this article is published and the following day. |
b*****h
发帖数: 783 | 12 shorted some...
【在 y*****l 的大作中提到】
: 盘前到8块了？！
: FDA Rejects Vivus Inc.'s Obesity Drug Qnexa
: Thursday 10/28/2010 9:18 PM ET - Dow Jones News
: Related Companies
: Symbol Last %Chg
: ARNA 1.59 0.00%
: VVUS 6.13 0.00%
: As of 4:00 PM ET 10/28/10
: By Jennifer Corbett Dooren
: Of DOW JONES NEWSWIRES
|
y*****l
发帖数: 5997 | 13 VVUS现在值多少钱？
【在 b*****h 的大作中提到】
: shorted some...
|
b*****h
发帖数: 783 | 14 这个没法具体估价，vvus的crl并不比arna的好多少，短期内并不能解决fda的concerns
。所以，向上很难上很多。
【在 y*****l 的大作中提到】
: VVUS现在值多少钱？
|
n**2
发帖数: 630 | |
f**********g
发帖数: 2252 | 16 Vivus Inc. (VVUS) shares surged 30% to $8.01 premarket as investors see hope
in FDA's rejection letter of its diet drug Qnexa. The company will file a
response in six weeks to the agency's concerns, and a conference call may
provide more insights. Jefferies notes Vivus' bullish stance in getting the
drug approved, but remains cautious toward the stock because of the ongoing
risk. |
p********e
发帖数: 1960 | 17 They probably trapped inside....now it is good time for them to get out...
【在 n**2 的大作中提到】
: 大摩和vvus大概有一腿？真是没天理啊。
|
b*****h
发帖数: 783 | 18 vvus的crl不是那么tough，增加了对orex的期望。。呵呵
【在 b*****h 的大作中提到】
: 呵呵, 过去的几个月obesity drug 起起落落，都搞的疲劳了，但是战斗还没有结束。
: 现在两个本来稍微领先的基本尘埃已定，剩下的就是OREX了。
: OREX 的效果和副作用都处于ARNA 和 VVUS的中间。所以，还是有一定猜想空间的。
: VVUS的CRL 对OREX有一定影响，如果是个dip，那是一个比较不错的进入时机。
|
v**********m
发帖数: 5516 | 19 VVUS悲剧居然被当好事，生生炒起来，看来大MM在减肥药上吃进太多货，出一点是一点。
有准备put它的吗？它的put还都挺贵。 |
w*******d
发帖数: 3714 | 20 orex有两年的数据吗？
【在 b*****h 的大作中提到】
: vvus的crl不是那么tough，增加了对orex的期望。。呵呵
|
|
|
b*****h
发帖数: 783 | 21 没有，他们完成了4个一年的pivotal trials
【在 w*******d 的大作中提到】
: orex有两年的数据吗？
|
D******9
发帖数: 2665 | 22 should we short VVUS today? |
D******9
发帖数: 2665 | 23 should we short VVUS today? |
w*******d
发帖数: 3714 | 24 如果一年数据就通过了，fda专家不是打自己脸么，最好结果也就是要多数据吧
【在 b*****h 的大作中提到】
: 没有，他们完成了4个一年的pivotal trials
|
w*******d
发帖数: 3714 | 25 VVUS如果不需要新的临床就能重新提交申请，回头上9块指日可待啊。Bloomberg早上说
他们先进还挺多的，说不定能撑过去。
【在 D******9 的大作中提到】
: should we short VVUS today?
|
