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K********g
发帖数: 9389 | 1 CHTP的Priority Review在2月23号，是么？如果我错了，请指正。 | b**********k
发帖数: 1262 | 2 AMLN 给我发包子吧。
【在 K********g 的大作中提到】
: CHTP的Priority Review在2月23号，是么？如果我错了，请指正。
| s**********9
发帖数: 846 | 3 第一个还是第二个？
02/23/2012 Chelsea Therapeutics International CHTP Northera (NDA)
FDA panel review of Northera for treatment of symptomatic neurogenic
orthostatic hypotension
03/28/2012 Chelsea Therapeutics International CHTP Northera (NDA)
FDA decision on Northera for treatment of symptomatic neurogenic
orthostatic hypotension
【在 K********g 的大作中提到】
: CHTP的Priority Review在2月23号，是么？如果我错了，请指正。
| K********g
发帖数: 9389 | 4 我也不知道哦，看CHTP网站说是3月28号NDA，但是没有说Review Date.
也许你这个是对的，密切关注，我买了点，看能不能混点免费的巴费
【在 s**********9 的大作中提到】
: 第一个还是第二个？
: 02/23/2012 Chelsea Therapeutics International CHTP Northera (NDA)
: FDA panel review of Northera for treatment of symptomatic neurogenic
: orthostatic hypotension
: 03/28/2012 Chelsea Therapeutics International CHTP Northera (NDA)
: FDA decision on Northera for treatment of symptomatic neurogenic
: orthostatic hypotension
| K********g
发帖数: 9389 | 5 找到了，2月23号Review.
February 23, 2012: Cardiovascular and Renal Drugs Advisory Committee Meeting
Announcement
Center Date Time Location
CDER February 23, 2012
8:00 a.m. to 5:00 p.m. DoubleTree by Hilton Hotel Washington DC-Silver
Spring
The Ballrooms
8727 Colesville Road
Silver Spring, Maryland
Agenda
The committee will discuss new drug application (NDA) 203202, proposed trade
name NORTHERA (droxidopa capsules), submitted by Chelsea Therapeutics, Inc.
, for the treatment of symptomatic neurogenic orthostatic hypotension in
patients with primary autonomic failure (Parkinson's Disease, Multiple
System Atrophy, and Pure Autonomic Failure), Dopamine Beta-Hydroxylase
Deficiency, and Non-Diabetic Autonomic Neuropathy.
Meeting Materials
FDA intends to make background material available to the public no later
than 2 business days before the meeting. If FDA is unable to post the
background material on its Web site prior to the meeting, the background
material will be made publicly available at the location of the advisory
committee meeting, and the background material will be posted on FDA’s Web
site after the meeting.
Background Material
2012 Meeting Materials, Cardiovascular and Renal Drugs Advisory Committee1
Public Participation Information
Interested persons may present data, information, or views, orally or in
writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before February
8, 2012.
Oral presentations from the public will be scheduled between approximately 1
p.m. and 2 p.m., February 23, 2012. Those desiring to make formal oral
presentations should notify the contact person and submit a brief statement
of the general nature of the evidence or arguments they wish to present, the
names and addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before January
31, 2012.
Time allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open public
hearing session. The contact person will notify interested persons regarding
their request to speak by February 1, 2012.
Webcast Information
CDER will not be providing a webcast of the February 23, 2012 Cardiovascular
and Renal Drugs Advisory Committee meeting.
Contact Information
Kristina A. Toliver, PharmD
Center for Drug Evalulation and Research
Food and Drug Administration
10903 New Hampshire Avenue
WO31-2417
Silver Spring, Maryland 20993-0002
Telephone: (301) 796-9001
Fax: (301) 847-8533
E-mail: C***[email protected]
FDA Advisory Committee Information Line
1-800-741-8138
(301-443-0572 in the Washington DC area)
Code: 3014512533
Please call the Information Line for up-to-date information on this meeting
A notice in the Federal Register about last minute modifications that impact
a previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you should
always check the agency’s Website and call the appropriate advisory
committee hot line/phone line to learn about possible modifications before
coming to the meeting.
Persons attending FDA’s advisory committee meetings are advised that the
agency is not responsible for providing access to electrical outlets. FDA
welcomes the attendance of the public at its advisory committee meetings and
will make every effort to accommodate persons with physical disabilities or
special needs. If you require special accommodations due to a disability,
please contact Kristina Toliver at (301) 796-9001 at least 7 days in advance
of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings.
Please visit our Web site at Public Conduct During FDA Advisory Committee
Meetings2 for procedures on public conduct during advisory committee
meetings.
Notice of this meeting is given under the Federal Advisory Committee Act (5
U.S.C. app.2). | y*****l
发帖数: 5997 | 6 看起来不错啊，通过的可能性很大。刚稀释过，比较安全。
Chelsea Therapeutics is set for an FDA decision date for its product
candidate, Northera, for 03/28/2012. Northera is an orally active synthetic
precursor of norepinephrine, for the treatment of neurogenic orthostatic
hypotension. Currently approved and marketed in Japan by Dainippon Sumitomo,
Northera has accumulated over 15 years of proven safety and efficacy,
generating annual revenue of approximately $50 million in Japan. Earlier
this month it announced that it has completed its previously announced
underwritten public offering of 4,989,275 shares of common stock, including
650,775 shares issued pursuant to the underwriters exercise in full of their
over allotment option, at a public offering price of $4.75 per share.
CHTP currently trades at $4.94 with the average analyst-52 week price target
being $10.5.
【在 K********g 的大作中提到】
: 我也不知道哦，看CHTP网站说是3月28号NDA，但是没有说Review Date.
: 也许你这个是对的，密切关注，我买了点，看能不能混点免费的巴费
:
:
:
| s*****e
发帖数: 1368 | 7 看样子不错，不过我还是看我自己的池子算了。贪多嚼不烂。 | d****9
发帖数: 34 | 8 同意
【在 K********g 的大作中提到】
: CHTP的Priority Review在2月23号，是么？如果我错了，请指正。
| K********g
发帖数: 9389 | | s**********9
发帖数: 846 | | K********g
发帖数: 9389 | 11 黑庄在做啥？打压吸筹还是知道内幕？
但这是Priority Review，应该没啥内幕的，所以确认为打压吸筹
【在 s**********9 的大作中提到】
: 少买点。等等。
| p********e
发帖数: 1960 | 12 co-ask..."big down" to 4.36...
【在 K********g 的大作中提到】
: 黑庄在做啥？打压吸筹还是知道内幕？
: 但这是Priority Review，应该没啥内幕的，所以确认为打压吸筹
| K********g
发帖数: 9389 | 13 Bought another 2000 Shares。
【在 p********e 的大作中提到】
: co-ask..."big down" to 4.36...
| K********g
发帖数: 9389 | 14 卖掉了，算了。不想担风险。毕竟去年2月的306A试验不成功。 |
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