y*****l
发帖数: 5997 | 1 搞生物的或者熟悉的说几句吧。我就不点名了，谢谢。 |
r******2
发帖数: 754 | 2 DCTH looks good to me.
AUXL要找生物鱼。 |
y*****l
发帖数: 5997 | 3 DCTH是不错。
AUXL生物鱼们也不熟，比较麻烦。现在大盘不好他也弹不起来了。
【在 r******2 的大作中提到】
: DCTH looks good to me.
: AUXL要找生物鱼。
|
b**********k
发帖数: 1262 | |
y*****l
发帖数: 5997 | 5 Delcath Submits CE Mark Technical File for Hepatic ChemoSAT(TM) Delivery
System
Monday 12/06/2010 6:30 AM ET - Pr Newswire
Related Companies
Symbol Last %Chg
DCTH 9.94 0.40%
As of 11:17 AM ET 12/6/10
Delcath Systems, Inc. (Nasdaq: DCTH) today announced that the Company has
submitted its CE Mark Technical File to its European Notified Body to obtain
CE Mark approval for its proprietary chemosaturation system, which the
Company intends to market in the European Union (EU) as the Delcath Hepatic
ChemoSAT(TM) Delivery System. CE Marking is an indication that a medical
device complies with the essential requirements of applicable medical device
directives, and that the device has been subjected to conformity assessment
procedures. Receipt of the CE Mark will allow Delcath to market and sell
the product in countries in the EU.
"The EU represents an attractive opportunity for this product," said Eamonn
P. Hobbs, CEO & President of Delcath Systems. "Our filing in the EU is
seeking an indication for the percutaneous intra-arterial administration of
a chemotherapeutic agent (melphalan hydrochloride) to the liver. With the EU
's aging population and liver cancer rates on the rise we believe the
Hepatic ChemoSAT Delivery System will fulfill an unmet clinical need for
many liver cancer patients in this region. With the submission of our
Technical File, and successful completion of the audits of our quality
system and manufacturing facility, we expect potential CE Mark approval in
mid-2011."
"With respect to U.S. regulatory status, we continue to expect to submit the
remaining modules of our New Drug Application (NDA) to the U.S. Food and
Drug Administration (FDA) by the end of 2010, and will make additional
announcements as we progress," added Mr. Hobbs.
【在 y*****l 的大作中提到】
: 搞生物的或者熟悉的说几句吧。我就不点名了，谢谢。
|
b**********k
发帖数: 1262 | 6 彪啦 彪啦。。。。
obtain
【在 y*****l 的大作中提到】
: Delcath Submits CE Mark Technical File for Hepatic ChemoSAT(TM) Delivery
: System
: Monday 12/06/2010 6:30 AM ET - Pr Newswire
: Related Companies
: Symbol Last %Chg
: DCTH 9.94 0.40%
: As of 11:17 AM ET 12/6/10
: Delcath Systems, Inc. (Nasdaq: DCTH) today announced that the Company has
: submitted its CE Mark Technical File to its European Notified Body to obtain
: CE Mark approval for its proprietary chemosaturation system, which the
|
f**********g
发帖数: 2252 | 7 Cong to all holders!
【在 b**********k 的大作中提到】
: 彪啦 彪啦。。。。
:
: obtain
|
C********k
发帖数: 560 | 8 希望不要又掉下去了，都快年底了， 希望mm 早点抬起来 然后套利....
【在 f**********g 的大作中提到】
: Cong to all holders!
|
K**********r
发帖数: 2640 | 9 乌鸦嘴啊。
今天早上加仓d**[email protected], 加仓r*[email protected]。都很及时啊，哈哈。。。
【在 C********k 的大作中提到】
: 希望不要又掉下去了，都快年底了， 希望mm 早点抬起来 然后套利....
|
b**********k
发帖数: 1262 | 10 死胖子， 你才乌鸦嘴。。。。
算了， 懒得跟你计较了。。
说错了。。。
少打了不字， 我这账户已经加不了仓了。。。
再下来就只有哭的分了。。。
【在 K**********r 的大作中提到】
: 乌鸦嘴啊。
: 今天早上加仓d**[email protected], 加仓r*[email protected]。都很及时啊，哈哈。。。
|
y*****l
发帖数: 5997 | 11 你的飞猪头像不错啊。往后叫你飞猪了，呵呵。
【在 r******2 的大作中提到】
: DCTH looks good to me.
: AUXL要找生物鱼。
|
y*****l
发帖数: 5997 | 12 又来BSO了，dcth通过率有几成把握？
【在 K**********r 的大作中提到】
: 乌鸦嘴啊。
: 今天早上加仓d**[email protected], 加仓r*[email protected]。都很及时啊，哈哈。。。
|
K**********r
发帖数: 2640 | 13 通过与否是明年的事，现在不在考虑之内。FDA的申请递交后，抗战就要结束了，待到
解放战争，就要考虑是否将革命进行到底了。
【在 y*****l 的大作中提到】
: 又来BSO了，dcth通过率有几成把握？
|
