l****i
发帖数: 3339 | | v**********m
发帖数: 5516 | 2 十月中旬前可能会有一个10%左右的小波。YMYD。
【在 l****i 的大作中提到】
: 可以进吗
:
| l****i
发帖数: 3339 | 3 为什么FDA接受要这么久
昨天搞了一点 应该要拉一下吧 | s**********9
发帖数: 846 | 4 bought 2000 shares at 1.68 | v**********m
发帖数: 5516 | | v**********m
发帖数: 5516 | 6 觉得MM要开始炒了。
JMP Securities Initiates Coverage on Delcath Systems (DCTH)
Posted by James Brewer on Sep 19th, 2012 // No Comments
Delcath Systems, Inc. logoJMP Securities started coverage on shares of
Delcath Systems (NASDAQ: DCTH) in a research report released on Wednesday
morning. The firm issued an outperform rating and a $4.00 price target on
the stock.
Shares of Delcath Systems opened at 1.82 on Wednesday. Delcath Systems has a
one year low of $1.40 and a one year high of $4.74. The company’s market
cap is $121.8 million.
Delcath Systems last issued its quarterly earnings data on Tuesday, August
7th. The company reported ($0.26) earnings per share (EPS) for the quarter,
beating the consensus estimate of ($0.30) by $0.04. Analysts expect that
Delcath Systems will post $-0.98 EPS for the current fiscal year.
Delcath Systems, Inc. (Delcath) is a development-stage company that has
developed a system designed to administer high dose chemotherapy and other
therapeutic agents to diseased organs or regions of the body.
Stay ahead of the market with our daily email update that provides a summary
of analysts' upgrades, downgrades and new coverage. Click here to register
now. | s**********9
发帖数: 846 | | l****i
发帖数: 3339 | 8 JMP是什么
a
【在 v**********m 的大作中提到】
: 觉得MM要开始炒了。
: JMP Securities Initiates Coverage on Delcath Systems (DCTH)
: Posted by James Brewer on Sep 19th, 2012 // No Comments
: Delcath Systems, Inc. logoJMP Securities started coverage on shares of
: Delcath Systems (NASDAQ: DCTH) in a research report released on Wednesday
: morning. The firm issued an outperform rating and a $4.00 price target on
: the stock.
: Shares of Delcath Systems opened at 1.82 on Wednesday. Delcath Systems has a
: one year low of $1.40 and a one year high of $4.74. The company’s market
: cap is $121.8 million.
| v**********m
发帖数: 5516 | 9 如果历史重演，下两周会有10-15% 的小波来迎接FDA的接受信或据信。
如果1）DCTH的管理层不是太猪头，2）这个会议确实再今年1月份开过（我没有再DCTH
公司的网站查到确切的消息），那么FDA非常可能再10月12日或15日宣布给与DCTH快速
审批。
等FDA决定是否接受后，再讨论DCTH的走向;另外千万注意DCTH在等FDA的决定前增发股
票。
各位见好就收。
======
after consultation with a variety of experts and the FDA, we have agreed to
include the addition of the Generation 2 filter in the NDA as a technical
change as part of the CMC or Chemistry, Manufacturing, and Control module.-
Delcath Systems 's CEO Discusses Q2 2012 Results - Earnings Call Transcript
========FDA Schedules Delcath Pre-New Drug Application Meeting Date
NEW YORK, Oct. 26, 2011 /PRNewswire via COMTEX/ -- Delcath Systems, Inc. (
NASDAQ: DCTH) announced today that the U.S. Food and Drug Administration (
FDA) has responded to the Company's request made in September for a pre-New
Drug Application (NDA) meeting and has scheduled a date in mid-January 2012.
Delcath plans to submit the NDA for its proprietary chemosaturation system,
used in the treatment of patients with metastatic melanoma in the liver
through the percutaneous intra-arterial administration of melphalan
hydrochloride, after the Company has incorporated FDA's feedback from that
meeting into the NDA submission.
Delcath currently expects to update investors on its U.S. and international
regulatory progress, EU commercialization preparations and other corporate
progress in the third quarter 2011 during a conference call on Monday,
November 7, 2011 at 4:30 PM EST. The Company will issue details of the call
later this week. | v**********m
发帖数: 5516 | 10 内部和机构持股比例在6/30的filling中大幅增加。 | | | b*****h
发帖数: 783 | 11 也许可以赌赌review filing..
【在 v**********m 的大作中提到】
: 内部和机构持股比例在6/30的filling中大幅增加。
| v**********m
发帖数: 5516 | 12 这个过的可能性还是挺大的。个人觉得应该有70%。
AF的那个bash理由（二代的透析设备加入此次申请）比较牵强。
原因二，一）FDA批准二代的透析设备可以用在临床试验上；二）欧盟已经批准了这个
二代的透析设备。
在2011年，FDA在DCTH被拒的理由中提到了设备的生产，消毒等方面，现在这些都已经
不是问题。
【在 b*****h 的大作中提到】
: 也许可以赌赌review filing..
| v**********m
发帖数: 5516 | | v**********m
发帖数: 5516 | 14 http://seekingalpha.com/article/894061-delcath-systems-an-exclu
Delcath Systems: An Exclusive Interview With ROTH Capital Senior Analyst
September 28, 2012 | about: DCTH
Disclosure: I am long DCTH. (More...)
Today I have the pleasure of publishing an exclusive interview that took
place this week between me and one of the leading senior analysts for
medical technology, Mr. Matt Dolan of ROTH Capital Partners. Mr. Dolan has
followed the industry for nearly a decade and has been the senior analyst at
ROTH for about six years. His investment views have been cited in numerous
publications, and he has spoken as an industry expert on Capitol Hill. Prior
to joining ROTH Capital, Mr. Dolan helped develop a trading group at the
Chicago Board of Trade and Chicago Board Options Exchange and also worked as
an analyst with a hedge fund in New York, specializing in small-cap medical
device, biotechnology, and pharmaceutical companies. In this interview, we
discussed the major challenges facing Delcath Systems (DCTH).
Delcath is a specialty pharmaceutical and medical device company that
focuses on treatments for cancer. The company's lead product is CHEMOSAT, a
chemosaturation therapy system designed to administer high-dose chemotherapy
and other therapeutic agents to diseased organs or regions of the body,
while controlling the systemic exposure of those agents. The first
application that Delcath developed CHEMOSAT for is the treatment of patients
with liver metastases. In 2010, Delcath announced that its randomized Phase
III clinical trial for patients with metastatic melanoma in the liver had
successfully achieved the study's primary endpoint of extended hepatic
progression-free survival.
The Company filed a New Drug Application (NDA) in December 2010, seeking the
U.S. Food and Drug Administration (FDA) approval for commercial sale of its
CHEMOSAT system with melphalan hydrochloride for use in the treatment of
patients with metastatic melanoma in the liver. However, the FDA declined to
review it and asked for more information about the manufacturing plant
inspection timing, product and sterilization validations and additional
safety information. In August 2012, Delcath resubmitted the NDA with a
second-generation hemofiltration cartridge, which has demonstrated greater
efficiency in melphalan removal from the blood in bench-top and in vivo
porcine studies.
"Our team has achieved a significant milestone with the filing of our
NDA. 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."
- Eamonn P. Hobbs, President and CEO of Delcath Systems.
The FDA has granted Delcath orphan drug designations for melphalan in the
treatment of ocular melanoma, cutaneous melanoma and metastatic
neuroendocrine tumors, as well as for doxorubicin in the treatment of HCC.
This grant allows for up to seven years of marketing exclusivity after
gaining FDA approval.
The CHEMOSAT system is already approved in Europe for the administration of
chemotherapy to the liver and the company is currently launching the product
in key commercial Europe markets. Delcath is also pursuing the approval of
the CHEMOSAT system in additional geographies worldwide.
Ben Yoffe: Mr. Dolan, what has changed since December 2010, when Delcath
filed its first NDA for the Company's proprietary chemosaturation system (
CHEMOSAT) for the treatment of patients with unresectable metastatic
melanoma in the liver?
Dolan: As you can imagine, much has happened in a year and nine months. The
FDA responded to Delcath's initial NDA with a refusal-to-file (RTF) letter,
which we believe was driven by a desire to see a better distinction between
the safety of the device versus that of the drug used in the pivotal trial.
Since receipt of the RTF, Delcath went back to its investigational sites to
collect further data to respond to these questions, and the company filed
another NDA including this data in mid-August. The FDA should determine
whether the application is acceptable in the very near-term (days to weeks),
and we expect the FDA to respond to this filing in the first half of next
year.
Additionally, Delcath has begun to commercialize the system internationally
and performed its first CHEMOSAT procedure earlier this year in Europe,
where the company subsequently introduced its second generation filter.
Yoffe: What can you tell us about CHEMOSAT's clinical data?
Dolan: From a clinical efficacy perspective, the treatment appears to work
quite well. Our conversations with treating physicians suggest that outcomes
were generally viewed as impressive. From the Phase III study, we saw a
five-fold improvement in hepatic progression free survival (hPFS), the study
's primary endpoint, as well as an improvement in PFS. More than half of
patients in the control arm ended up crossing over into the treatment arm of
the Phase III study, making it difficult to demonstrate an overall survival
benefit. However, a deeper dive into the data showed overall survival in
both the treated and crossover groups outpaced the control group that did
not cross over dramatically. So, we think the efficacy side of the equation
is quite strong for Delcath. From a safety perspective, the data we have
seen surrounds use of the Gen 1 filter, and the treatment appears to carry a
profile similar to that of systemic chemotherapy with melphalan. This makes
sense considering the CHEMOSAT system delivers a highly concentrated dose
of drug to the liver but only provides a typical systemic dose to a patient.
We would only expect the side effect profile to improve with the more
efficient Gen 2 filter.
Yoffe: Does the company seek an approval of CHEMOSAT in the U.S. without any
Gen 2 filter data from clinical trials?
Dolan: The Gen 2 filter carries higher efficiency than the first generation
device and has had some very positive initial experience in Europe, reducing
many of the morbidities associated with the procedure due to its higher
filtering efficiency. Therefore, Gen 2 represents a major improvement for
patient tolerability of the chemosaturation procedure. One patient that
received two treatments, one with Gen 1 and one with Gen 2, indicated that
the difference in morbidity levels was quite dramatic and that she had even
debated not undergoing the second procedure given the difficulties
experienced in her first round of therapy with Gen 1. Recovery was much
swifter, and side effects were minimized.
Gen 2 was included as a technical amendment to Delcath's NDA in the U.S.,
which would represent the quickest path to approval for this device. We
think it is likely the FDA could respond to the question of Gen 2 either as
one complete package or separately from that of the primary NDA for the
first generation CHEMOSAT system. Based on what we know today, we view it as
a promising sign that the FDA allowed Gen 2 to be included in Delcath's
Expanded Access Program (EAP) in the U.S., which is actively enrolling
patients.
Yoffe: Do you expect the FDA to grant Priority Review status to CHEMOSAT?
Dolan: At this stage, we place a higher probability on the company obtaining
Priority Review, which implies a PDUFA date somewhere in the February
timeframe. If the company fails to obtain Priority Review, we estimate the
difference would only be an additional few months.
Yoffe: What is the potential market for CHEMOSAT, if approved, in the U.S.?
Dolan: The company's initial targeted indication is melanoma metastatic to
the liver, including both cutaneous and ocular melanoma which collectively
imply over a $500 million opportunity in the U.S. In our analysis of this
market opportunity, we assume 2.5 procedures per patient and $15,000 per
procedure kit.
CHEMOSAT can also be viewed as a platform technology whereby any cancer
metastatic to the liver could potentially be treated, as well as other
cancer types beyond the liver through this perfusion technique. When we
include these opportunities, the numbers quickly add up to a multi-billion
dollar opportunity for Delcath over time.
Yoffe: What can you tell us about the competition in this market?
Dolan: Delcath's primary competitor will be existing treatment practices
with chemotherapy regimens. We don't see any direct competitors today that
have run significant trials, and specific to this type of hemofiltration
procedure, we believe Delcath's Orphan Drug designation will provide a
healthy, seven year head start for the company, assuming approval. Surgical
isolated hepatic perfusion was performed many years ago and was a precursor
to this treatment but was complex and carried significant morbidities. So,
the competitive landscape looks fairly clean. Of course, other effective
treatments and/or drug therapies could arise in time.
Yoffe: Are you satisfied with CHEMOSAT's sales in Europe so far?
Dolan: In Europe, Delcath only recently booked its initial revenues, so it
is difficult to assess how successful the company will be there based on
only a handful of procedures and some anecdotal feedback. The company has
purposely only introduced the system to 13 centers in seven countries, but
we would note that this exceeded management's initial guidance of entering
only six to eight European centers in 2012.
This is a methodical rollout, with this initial group serving as centers of
excellence and a more aggressive launch anticipated next year. Therefore,
revenues in Europe have been relatively insignificant and largely inline
with expectations to date. However, beyond the company's U.S. regulatory
pathway, European revenues will begin to be a more important component of
the story in Q412 and especially in 2013 as the company scales this launch.
In the meantime, we look for updates on treatments and reimbursement in key
European countries as early indicators of viability there.
I would also point out that Delcath is expanding beyond Europe, with
expectations to have treating centers in Australia and Hong Kong by the end
of this year. Over the next year or two, we look for an approval of the
system in Argentina, as well as the addition of Gen 2 in South Korea, Canada
, Singapore, and Brazil.
Yoffe: Is there any other significant products in Delcath's clinical-stage
pipeline?
Dolan: As previously mentioned, the CHEMOSAT system can be viewed as a
possible platform technology, used in treating other cancer types metastatic
to the liver as well as potentially being used in other major organs with
tumor burden. The company is pursuing some new indications with clinical
studies, such as one for colorectal cancer and one for hepatocellular
carcinoma both metastatic to the liver, and success or failure with these
indications will determine the technology's perception as a true platform.
Delcath is also working on obtaining European approval for a system that
filters doxorubicin, which could open the door to more prospective patients
there. Perhaps more importantly, doxorubicin is a commonly used therapy for
liver cancer in Asia, as compared to melphalan, and therefore, this ability
could open the door to a much larger liver cancer treatment market there.
The prevalence of liver disease there is an order of magnitude higher than
in the U.S. and Europe, therefore offering a substantial potential
opportunity for Delcath.
Yoffe: Do you think the company is funded well enough to get through all of
the upcoming steps or will be looking for additional funding?
Dolan: The company is funded to get through some key milestones in the
coming quarters, which could help support the stock's valuation if positive.
However, considering its current burn rate, we do assume the company will
need to obtain additional funding, perhaps following progress with its U.S.
regulatory approval process.
Yoffe: For closing, what is your one-year price target for DCTH?
Dolan: Our target price is $6 per share (268% upside on yesterday's closing
price), which is driven heavily by the assumption that the company obtains
regulatory approval in the U.S. Assuming this is the case, we look for
revenues to begin ramping next year and to increase more aggressively in
2014. We apply a revenue multiple of 4x our FY14 projection, discounted at
15% per year.
We also currently have a Buy rating on DCTH, which is again based on the
expectation of positive early experience in Europe, U.S. regulatory approval
, and a successful U.S. commercial launch | v**********m
发帖数: 5516 | 15 昨天下午开始拉了，看来15% 的估计有些保守。
DCTH
to
【在 v**********m 的大作中提到】
: 如果历史重演，下两周会有10-15% 的小波来迎接FDA的接受信或据信。
: 如果1）DCTH的管理层不是太猪头，2）这个会议确实再今年1月份开过（我没有再DCTH
: 公司的网站查到确切的消息），那么FDA非常可能再10月12日或15日宣布给与DCTH快速
: 审批。
: 等FDA决定是否接受后，再讨论DCTH的走向;另外千万注意DCTH在等FDA的决定前增发股
: 票。
: 各位见好就收。
: ======
: after consultation with a variety of experts and the FDA, we have agreed to
: include the addition of the Generation 2 filter in the NDA as a technical
| t*********n
发帖数: 1292 | |
|
