v**********m
发帖数: 5516 | 1 本人觉得AF有些扯淡，特别是那个DCTH替FDA说话的那段。AF觉得自己是豪猪吗？还吓
得后颈毛都竖起来。
在AF提供的时间点内可以做做波段。
by- Var.
--------------------------------
D. Jones asks, "Do you have an opinion on Delcath Systems(DCTH)? They are
submitting their NDA [New Drug Application] later this year and I was
wondering if it's time to buy before a potential run-up."
I'm not a Delcath fan, never been one, mainly because of the small
commercial market for the company's Chemosaturation (ChemoSat) liver-tumor
treatment system. I haven't had big concerns about the FDA approvability of
ChemoSat, more that Delcath could never deliver sufficient revenue to
generate a meaningful profit. [Sales to date in Europe, where ChemoSat is
approved, have been minimal.]
This was all before FDA, in February 2011, issued a refuse-to-file letter
citing unanswered questions about ChemoSat's safety. [ChemoSat is already
approved in Europe but only as a medical device; FDA considers it a drug and
therefore holds approval to a stricter regulatory standard.
Delcath finally resubmitted ChemoSat to FDA on Aug. 15. It took 18 months to
refile -- a really long time. Delcath says all the patient records have
been updated with the safety data that FDA requested but the company has not
told us any details about these data or whether the data will be sufficient
to assuage FDA's concerns. This is a risk.
The ChemoSat resubmission also seeks approval of the device replacing the
old Generation 1 filter with a new Generation 2 filter. These filters remove
melphalan from a patient's blood as the toxic chemotherapy exits the liver
before it can enter the bloodstream and cause harm.
These filters play a very important safety function so it's concerning that
Delcath is seeking ChemoSat's approval without any Gen 2 filter efficacy or
safety data from clinical trials. All of the ChemoSat studies to date have
used the Gen 1 filter. That's potentially a big risk.
Delcath CEO Eamonn Hobbs claims FDA deemed it "acceptable" to re-file
ChemoSat with the untested Gen 2 filter. The hairs on the back of my neck
stand straight up whenever I hear a bio-pharma CEO speak for FDA. Place full
trust in Hobbs' assurance about the Gen 2 filter at your peril.
If you're a trader interested in Delcath and any possible stock run-up,
watch for FDA's acceptance of the ChemoSat resubmission, which should be
announced at the end of September or mid-October at the latest. If FDA
decides to review ChemoSat and grants priority review, the approval decision
date will be mid-February 2013. A standard review will extend the approval
decision date to June 2013. | v**********m
发帖数: 5516 | 2 另外一篇pump文
Delcath seeks FDA approval for chemo device
The Business Review by Barbara Pinckney, Reporter
Date: Friday, August 17, 2012, 2:17pm EDT - Last Modified: Friday, August 17
, 2012, 2:18pm EDT
Enlarge Image
Eamonn Hobbs, CEO of Delcath, said the company has asked the FDA for
priority review status on the company's liver chemotherapy system for sales
in the United States.
Donna Abbott Vlahos | The Business Review
Eamonn Hobbs, CEO of Delcath, said the company has asked the FDA for
priority review status on the company's liver chemotherapy system for sales
in the United States.
Delcath Systems Inc. may be less than six months away from being able to
sell its liver chemotherapy system in the United States—which could be a
turning point for a company that has been in the development stage for 24
years.
Delcath (Nasdaq: DCTH), which is based in New York City but has
manufacturing and research operations in Queensbury, filed a new drug
application, or NDA, with the U.S. Food and Drug Administration Aug. 15.
The application covers both the Hepatic Chemostat therapy device and the
drug—melphalan hydrochloride, or Alkeran—it delivers to treat a certain
form of liver cancer called metastic melanoma.
Eamonn Hobbs, CEO of Delcath, said the company has asked the FDA for
priority review status, and expects to receive it.
“We believe we qualify hands down, because there really isn’t anything
available for these patients today and that is the main criteria,” Hobbs
said.
That would mean possible approval by the middle of February, allowing
Delcath to access a U.S. market Hobbs put at about $500 million.
The company also plans to conduct clinical research to support using the
chemostat system to treat other diseases, including primary liver cancer and
colon cancer.
That would bring the total potential U.S. market to about $2 billion, Hobbs
said.
Delcath had filed an NDA for Chemostat in February 2011, but the FDA
declined to review it, instead requesting more information about the product
and its sterilization.
The company began selling the device without the drug in Europe earlier this
year. On Aug. 7, it announced second quarter results that include its first
commercial revenue—$106,000. The company had a net loss of $14.5 million.
Delcath has two sites in Queensbury, a production facility on Queensbury
Avenue and a research and development center on Country Club Road.
It employs a total of 60 people in the Warren County community, two dozen of
whom were hired in the past year.
The company is expanding the Country Club Road facility, but Hobbs could not
say how many jobs will be added. | v**********m
发帖数: 5516 | | s**********9
发帖数: 846 | 4 bought 2000 shares at 1.93 | v**********m
发帖数: 5516 | 5 来回吃波段，给个包子吧，蕃薯。
【在 s**********9 的大作中提到】
: bought 2000 shares at 1.93
| s**********9
发帖数: 846 | | t******o
发帖数: 6493 | 7 太无耻了
【在 s**********9 的大作中提到】
: 又增发聊
| v**********m
发帖数: 5516 | 8 哪里看到的？什么价位？
我还以为要到10月份后才搞增发，那时FDA的快速通道review也该批准了。
【在 s**********9 的大作中提到】
: 又增发聊
| v**********m
发帖数: 5516 | 9 我没有看到这两天有什么新闻。
http://www.delcath.com/news-events/news/20120101/99999999/
这个可能增发的registration不是早就有的吗？
这个新闻就是牛屎，这个不是早就知道了吗？
------------
http://online.wsj.com/article/BT-CO-20120831-712766.html
Specialty-pharmaceutical and medical-device maker Delcath, which said it may
offer securities and selling stockholders may offer shares of common stock
for up to $100 million, saw shares fall 8.6% to $1.81 after hours. |
|
