d******8
发帖数: 1972 | 1 WASHINGTON, D.C. (TheStreet) --Chelsea Therapeutics(CHTP_) faces a big
challenge Thursday -- convincing a panel of outside experts to look
favorably on its hypotension drug Northera despite a damning FDA review that
recommended against the drug's approval.
"On the basis of the safety concerns, compounded by absence of evidence of
durability of effect, my regulatory recommendation is that we should not
grant approval for droxidopa at this time," concluded FDA reviewer Melanie
Blank in an FDA brie... 阅读全帖 |
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s**********9
发帖数: 846 | 2 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 |
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t******r
发帖数: 8600 | 3 “unlikely”应该是关键词。
In the last panel meeting for Chelsea's drug Northera (droxidopa) in Feb,
2012, the voting result diverged from the FDA critical review. The panel
voted 7:4 in favor to approve Northera, though members expressed caution on
its effectiveness. FDA still rejected the drug in March 2012, and advised
the company that ongoing Study 306B was unlikely to provide sufficient
confirmatory evidence to support Northera's NDA (new drug application). |
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c******n
发帖数: 145 | 4 看来是Conditional approval
The NORTHERA approval was granted under the FDA's accelerated approval
program, which allows for conditional approval of a medicine that fills a
serious unmet medical need, provided additional confirmatory studies are
conducted. The package insert indicates that effectiveness beyond 2 weeks of
treatment has not yet been demonstrated, therefore the continued
effectiveness of NORTHERA in patients should be assessed periodically. A
multi-center, placebo-controlled, randomi... 阅读全帖 |
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y*****l
发帖数: 5997 | 5 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... 阅读全帖 |
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l*********m
发帖数: 16971 | 6 Shares of Chelsea Therapeutics International Ltd. CHTP -1.20% dropped 25%
Thursday after U.S. regulators declined to approve the company's proposed
new treatment for a form of low blood pressure.
The Food and Drug Administration asked for an additional clinical study to
support the efficacy of the drug, Northera, Chelsea announced late Wednesday
. That will likely delay any agency approval into 2013 or 2014, analysts
estimated.
What's more, the FDA indicated that Northera's prescribing label wo... 阅读全帖 |
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c******n
发帖数: 145 | 7 Chelsea Therapeutics International, Ltd. (Nasdaq: CHTP) today announced
that the U.S. Food and Drug Administration ( FDA ) granted accelerated
approval of NORTHERATM (droxidopa) for the treatment of symptomatic
neurogenic orthostatic hypotension (NOH). NORTHERA is the first and only
therapy approved by the FDA which demonstrates symptomatic benefit in
patients with NOH.
NORTHERA(TM) (droxidopa) is available in 100mg, 200mg and 300mg capsules. |
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d******8
发帖数: 1972 | 8 Feb 23 (Reuters) - Chelsea Therapeutics International Ltd's hypotension drug
Northera should be approved for use in the United States, a committee of
independent experts recommended on Thursday.
The panel assembled by the Food and Drug Administration voted 7-4 for
approval of the drug known generically as droxidopa, despite government
warnings about whether the treatment is safe and effective for treating
chronic illness. One committee member abstained and another did not cast a
vote. |
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V*****2
发帖数: 7930 | 9 You can and should read Blank's entire Northera review. Here are key,
summary excerpts:
In summary, in support of approval, there is one trial (Study 301) that is
strongly supportive of efficacy of droxidopa and contains many of the
attributes of a single trial that might stand alone to support efficacy:
large and multicenter trial, improvement on multiple ordered endpoints
including OHSA Item 1, OHQ and systolic blood pressure, and statistically
very persuasive findings. From a post-hoc analysi... 阅读全帖 |
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G********p
发帖数: 3504 | 10 The FDA posted a review of Northera on Friday, recommending the drug not be
approved at this time. |
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c*******o
发帖数: 3829 | 11 In response to abnormal trading activity in its common stock, Chelsea
Therapeutics International, Ltd. announced on February 14, 2014 that no
decision regarding its Northera NDA has been received from the U.S. Food &
Drug Administration as of 11:45 AM on such date. |
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H******4
发帖数: 67 | 12 "As a result of severe weather conditions leading to an office closure, FDA
today notified Chelsea Therapeutics that the goal date for the Company's
NORTHERA NDA has been extended to the next business day, or Tuesday,
February 18, 2014." |
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k******e
发帖数: 214 | 13 CHTP: Chelsea's Northera NDA reportedly approved, shares halted |
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m********o
发帖数: 2088 | 14 Chelsea Therapeutics (CHTP) NORTHERA approved by FDA |
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p********e
发帖数: 1960 | 17 SCOTTRADE News Headline放出的假新闻？？？ |
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h*********r
发帖数: 2844 | 18 Wedbush continues to see a partnership or acquisition of Chelsea
Therapeutics
With Northera's recent approval, Wedbush continues to believe Chelsea
Therapeutics is an attractive target for multiple pharmaceutical companies
and that a partnership or acquisition of the company is on the horizon.
Shares of Chelsea Therapeutics is Outperform rated with an$8 price target. |
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p********e
发帖数: 1960 | 19 DNDN, KERX, BPAX, CHTP, OPXA
http://seekingalpha.com/article/286963-5-cheap-biotech-stocks-t
Most biotech stocks have experienced very sharp drops as the markets have
plummeted over economic concerns. However, biotechs are not as economically
sensitive as other companies and therefore are likely to rebound sharply in
the coming days. These dirt cheap biotech companies all have interesting
products in the pipeline which could become major catalysts in the future.
The lower priced stocks tend to h... 阅读全帖 |
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y*****l
发帖数: 5997 | 20 22 Hot Drugs Facing FDA Approval in 2012
By Adam Feuerstein 11/29/11 - 08:55 AM EST
BOSTON (TheStreet) -- Here's your first look at the biotech and
pharmaceutical companies with pending FDA drug approval decisions in 2012.
The calendar on the following pages captures nearly two-dozen U.S.
regulatory events -- FDA drug approvals and advisory panels -- expected
between December 2011 and July 2012. As every savvy biotech investor and
trader knows, the volatility in biotech and drug stocks ramps sig... 阅读全帖 |
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K********g
发帖数: 9389 | 21 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... 阅读全帖 |
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L*********n
发帖数: 1225 | 22 08:52 DJN DJ Chelsea Therapeutics: FDA Questions Risk-Benefit Of Northera
CHTP: $2.95 -$2.03 |
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w*********7
发帖数: 2883 | 23 haha ,彻底结束了。
U.S. health regulators recommended that Chelsea Therapeutics International
Ltd's (CHTP.O) hypotension drug Northera not be approved for use in the
United States, sending the company's shares down over 14 percent.
好狠~ |
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y*****l
发帖数: 5997 | 24 来自主题: _pennystock版 - CHTP 老相好,图不错,生物鱼来说说最近CHTP有什么进展.
http://finviz.com/quote.ashx?t=CHTP&ty=c&ta=1&p=d&b=1
Chelsea Therapeutics is a biopharmaceutical development company that
acquires and develops innovative products for the treatment of a variety of
human diseases, including central nervous system disorders. Chelsea is
currently pursuing FDA approval in the U.S. for Northera (droxidopa), a
novel, late-stage, orally-active therapeutic agent. |
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