B******o
发帖数: 565 | | v**********m
发帖数: 5516 | 2 这个就先hold嘛。
【在 B******o 的大作中提到】
: 有什么理由没？好像没看到什么坏消息啊
| v**********m
发帖数: 5516 | | s**********9
发帖数: 846 | | j****e
发帖数: 624 | | m*******y
发帖数: 904 | 6 8/7 ER.
【在 j****e 的大作中提到】
: 继续跌啊
| l****i
发帖数: 3339 | 7 不大妙啊 估计提交要延迟
【在 m*******y 的大作中提到】
: 8/7 ER.
| v**********m
发帖数: 5516 | 8 8/10/2012 5:34 AM ET
(RTTNews) - Having transitioned from a development stage company to a
commercial organization with operational activities in April of this year,
Delcath Systems Inc. (DCTH:Quote) is gearing up to play its part of
NDA resubmission in the upcoming binary event.
The company's shares have lost over 40% of their value year-to-date, and
trade near their 52-week low. With the company scheduled to resubmit the New
Drug Application for its proprietary chemosaturation system
in a couple of days, it will be interesting to watch how the stock price
plays out in the coming days.
For readers who are new to Delcath, here's brief overview of the company's
business and the upcoming events to watch out for.
Delcath is a medical device company focused on oncology. The company's
proprietary technology - chemosaturation therapy, is designed to administer
high dose of anti-cancer drugs to diseased organs without
exposing the patient's entire body to those same potent levels of drug,
thereby limiting the toxic side-effects.
The company's initial focus is on the treatment of primary and metastatic
liver cancers. The product for which Delcath is seeking FDA approval is
Hepatic CHEMOSAT delivery system, and the filing is scheduled for
mid-August. Whether or not the FDA accepts the NDA for review will be known
within 60 days after submission of the NDA.
This is CHEMOSAT's second go-around with the FDA. Initially, the NDA for
CHEMOSAT was submitted in December of 2010. The filing was made on a rolling
basis. Much to the disappointment of the company,
which was optimistic that its NDA will be accepted for review, the FDA, on
February 22, 2011, refused the filing over concerns that the information
provided was insufficient for review.
Earlier this year, Delcath held a pre-NDA meeting with the FDA to discuss
the CHEMOSAT NDA submission and the reasons for refusing the NDA filing.
Last April, CHEMOSAT received CE Mark as a Class III medical device with an
indication for the percutaneous intra-arterial administration of a
chemotherapeutic agent (melphalan hydrochloride) to the liver. The first
CHEMOSAT procedure in Europe was conducted in February of this year, and to
date 16 such procedures have been performed at five EU centers.
The CHEMOSAT System received regulatory approval in Australia in February of
this year. In a recent SEC filing, the company noted that it has completed
the product notification process in New Zealand, with the
launch of the CHEMOSAT System expected in the second half of 2012 through
authorized distributors.
Hong Kong, South Korea, Singapore, Canada and Israel are the countries where
Delcath has submitted applications for regulatory approval of the CHEMOSAT
System.
delcath-081012.jpg
8/10/2012 5:34 AM ET
(RTTNews) - Delcath has also developed Generation Two version of the
CHEMOSAT system, and it received CE Mark approval as recently as April 5,
2012.
A quick look at the company's balance sheet...
Delcath generated its first product revenue in the company's history during
the second quarter of 2012.
In the second quarter ended June 30, 2012, Delcath incurred a net loss of $
14.51 million or $0.26 per share on revenue of $106 thousand. This compares
with a net loss of $5.46 million or $0.13 per share on no
revenue in the year-ago quarter.
The company ended June 2012 with $29.3 million of cash and cash equivalents.
The monthly cash spend for the remainder of 2012 is expected to decline
following the NDA submission, and the company believes that
it has access to sufficient capital to fund operating activities through
this year.
Delcath shares have thus far hit a 52-week low of $1.40 and a 52-week high
of $4.74. The stock gained over 8% on Thursday to close the day's trading at
$1.82.
If all goes well as planned, Delcath expects to receive FDA approval in 2013
. Will CHEMOSAT pass muster with the FDA? Stay tuned...
Click here to receive FREE breaking news email alerts for Delcath Systems
Inc. and others in your portfolio
by RTT Staff Writer
For comments and feedback: contact e*******[email protected] | d******8
发帖数: 1972 | | l****i
发帖数: 3339 | 10 买少了
【在 d******8 的大作中提到】
: 今天猛涨
| | | d******8
发帖数: 1972 | 11 是的，我也是，不过还是保险点。
【在 l****i 的大作中提到】
: 买少了
| y****8
发帖数: 421 | | v**********m
发帖数: 5516 | | m***9
发帖数: 1671 | | a*********7
发帖数: 30080 | 15 一起2？
【在 m***9 的大作中提到】
: 今天又跌回2了。。。
| l****i
发帖数: 3339 | 16 感觉不太好 明明月中要交nda 而且前几天er还confirm了
为什么还涨不上去
这几天量也不小 奇怪的很
【在 a*********7 的大作中提到】
: 一起2？
| v**********m
发帖数: 5516 | 17 NEW YORK, Aug. 15, 2012 /PRNewswire/ — Delcath Systems, Inc. (NASDAQ:DCTH)
announced today that it has submitted a New Drug Application (NDA) to the U.
S. Food and Drug Administration seeking approval for the Company’s
proprietary chemosaturation system for use with melphalan hydrochloride in
the treatment of patients with unresectable metastatic melanoma in the liver
. The Company included its Generation 2 filter in its NDA submission as a
technical change to the Chemistry, Manufacturing, and Control (CMC) module.
“Our team has achieved a significant milestone with the filing of our NDA,
” said Eamonn P. Hobbs, President and CEO of Delcath Systems. “We believe
that our chemosaturation system provides the opportunity to satisfy a high
unmet medical need to treat patients with unresectable metastatic melanoma
in the liver. We also believe including our Generation 2 filter in the CMC
module represents the fastest regulatory review path for the Generation 2
system, and that it is in the best interest of U.S. patients that we
accelerate the potential availability of Generation 2.”
“We have requested priority review of our NDA by the FDA. Assuming the NDA
is accepted and that priority review is granted, our expected Prescription
Drug User Fee Act (PDUFA) date would be in February of next year. Based
upon the strength of our Phase 1, 2 and 3 data, along with the limited
treatment options available for patients with unresectable melanoma
metastases in the liver, we believe that our application meets the FDA’s
criteria for priority review.”
In Delcath’s Phase 3 clinical trial (April 2010 data cutoff), comparing
treatment with the Company’s proprietary chemosaturation system to best
alternative care (BAC) revealed that patients treated with chemosaturation
therapy experienced a statistically significant extension in median hepatic
progression free survival (hPFS) of 5.4 months (p=0.0001, hazard ratio 0.39)
longer than patients treated with BAC according to independent review
committee (IRC) blinded intent-to-treat (ITT) analysis. Previously reported
investigator ITT analysis of these data showed an extension in median hPFS
of 6.4 months (p<0.0001, hazard ratio 0.28) longer than patients treated
with BAC. Priority review is granted by the FDA to those products that
address significant unmet medical needs or have the potential to provide
significant improvement compared to marketed products. The FDA has
previously granted Delcath two orphan drug designations for melphalan in
ocular and cutaneous melanoma, which will provide the Company with
exclusivity in these indications for seven years if the NDA is accepted,
reviewed and approved. | s**********9
发帖数: 846 | | l****i
发帖数: 3339 | 19 也卖掉了 感觉不太好
【在 s**********9 的大作中提到】
: sold at 2:05
| v**********m
发帖数: 5516 | | v**********m
发帖数: 5516 | 21
【在 v**********m 的大作中提到】
: 我也感觉不好，可是我的感觉往往对抗我。
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