g*e
2 楼
设了一个16块的订单。
b*p
3 楼
这个是药股中的战斗机。
50% off this morning. I know this is coming but just not sure when.
50% off this morning. I know this is coming but just not sure when.
m*9
4 楼
what happened?
b*p
5 楼
FDA tells Sarepta new drug filing for eteplirsen 'premature'
Sarepta provided an update on its discussions with the FDA regarding its
planned New Drug Application submission and confirmatory clinical study with
eteplirsen for the treatment of Duchenne muscular dystrophy. Citing recent
developments since Sarepta's last meeting with the agency, including a
failed study with a competitive product and recent natural history data in
DMD, the FDA indicated the new data raise "considerable doubt" about both
the dystrophin biomarker and the supportive clinical efficacy assessed on
the 6-minute walk test in the Phase IIb clinical study of eteplirsen. As a
result of these recent data, the FDA stated that they "currently consider an
NDA filing for eteplirsen as premature," Sarepta said. The FDA's request to
discuss different clinical endpoints, combined endpoints, and different DMD
subpopulations for a confirmatory clinical study, along with their
questions about dystrophin as a biomarker and the need for a placebo-
controlled study, will delay the initiation of dosing in the eteplirsen
confirmatory study until at least Q2 of 2014. A follow up meeting with FDA
has been scheduled to take place this month to discuss the confirmatory
study design, Sarepta added. The company said, "We are very disappointed
with the FDA's decision to reconsider their openness to a potential NDA
filing based on our current data and the resultant impact this change may
have on our efforts to achieve an earlier approval of eteplirsen."
Sarepta provided an update on its discussions with the FDA regarding its
planned New Drug Application submission and confirmatory clinical study with
eteplirsen for the treatment of Duchenne muscular dystrophy. Citing recent
developments since Sarepta's last meeting with the agency, including a
failed study with a competitive product and recent natural history data in
DMD, the FDA indicated the new data raise "considerable doubt" about both
the dystrophin biomarker and the supportive clinical efficacy assessed on
the 6-minute walk test in the Phase IIb clinical study of eteplirsen. As a
result of these recent data, the FDA stated that they "currently consider an
NDA filing for eteplirsen as premature," Sarepta said. The FDA's request to
discuss different clinical endpoints, combined endpoints, and different DMD
subpopulations for a confirmatory clinical study, along with their
questions about dystrophin as a biomarker and the need for a placebo-
controlled study, will delay the initiation of dosing in the eteplirsen
confirmatory study until at least Q2 of 2014. A follow up meeting with FDA
has been scheduled to take place this month to discuss the confirmatory
study design, Sarepta added. The company said, "We are very disappointed
with the FDA's decision to reconsider their openness to a potential NDA
filing based on our current data and the resultant impact this change may
have on our efforts to achieve an earlier approval of eteplirsen."
s*d
6 楼
RNA-based therapies are risky. I think SRPT will touch 15 first.
g*e
7 楼
Seems a new phase 3 is required, but cut the price more than 50% is overdone
. My take is the price will go over 20 by closing.
High risk bet, YMYD.
. My take is the price will go over 20 by closing.
High risk bet, YMYD.
s*t
8 楼
没买两个put?
s*d
10 楼
Eteplirsen is the most promising product on the pipeline. This will hurt
others in development: http://www.sareptatherapeutics.com/our-programs/
【在 b*****p 的大作中提到】
: 原来指望Eteplirsen能直接通过,现在FDA said it is premature.
others in development: http://www.sareptatherapeutics.com/our-programs/
【在 b*****p 的大作中提到】
: 原来指望Eteplirsen能直接通过,现在FDA said it is premature.
b*p
11 楼
cash 273,644k
一个季度要烧大概24,933k
估计暂时没有增发的危险。
一个季度要烧大概24,933k
估计暂时没有增发的危险。
m*9
12 楼
不过就是一个药没有提前批,要再审审,怎么就一下子都失去信心了呢?
g*e
25 楼
last minute filled:
11/15/2013
Pending CMA-Edge xxX-xxxxxx Buy
SAREPTA THERAPEUTICS INC SRPT 200 16.00 (3,200.00)
11/15/2013
Pending CMA-Edge xxX-xxxxxx Buy
SAREPTA THERAPEUTICS INC SRPT 200 16.00 (3,200.00)
r*r
30 楼
接了飞刀,立刻成了股东。。。
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