t****e
发帖数: 89 | |
p********e
发帖数: 1960 | |
A*****a
发帖数: 873 | |
c*******o
发帖数: 3829 | 4 Schwab, Scotttrade, TD都说批了。 |
s****7
发帖数: 2507 | |
t****e
发帖数: 89 | |
c*******o
发帖数: 3829 | 7 你更猛。
【在 t****e 的大作中提到】
: 这个是去年的
|
t****e
发帖数: 89 | 8 看错了。。。这个是另一个公司。。。
【在 c*******o 的大作中提到】
: 你更猛。
|
w*******8
发帖数: 865 | |
g**a
发帖数: 953 | 10 yep，so does IB. Just need to see the detail, such as labeling and
restrictions.
【在 c*******o 的大作中提到】
: Schwab, Scotttrade, TD都说批了。
|
p*****i
发帖数: 197 | |
t****e
发帖数: 89 | 12 hahahahah!!!!!!!!!!!!!!!!!!!!!!!!!!
【在 p*****i 的大作中提到】
: FDA 刚出的
: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm38
|
c******n
发帖数: 145 | 13 Chelsea Therapeutics International, Ltd. (Nasdaq: CHTP) today announced
that the U.S. Food and Drug Administration ( FDA ) granted accelerated
approval of NORTHERATM (droxidopa) for the treatment of symptomatic
neurogenic orthostatic hypotension (NOH). NORTHERA is the first and only
therapy approved by the FDA which demonstrates symptomatic benefit in
patients with NOH.
NORTHERA(TM) (droxidopa) is available in 100mg, 200mg and 300mg capsules. |
c******n
发帖数: 145 | 14 看来是Conditional approval
The NORTHERA approval was granted under the FDA's accelerated approval
program, which allows for conditional approval of a medicine that fills a
serious unmet medical need, provided additional confirmatory studies are
conducted. The package insert indicates that effectiveness beyond 2 weeks of
treatment has not yet been demonstrated, therefore the continued
effectiveness of NORTHERA in patients should be assessed periodically. A
multi-center, placebo-controlled, randomized study, which includes a 4 week
randomized withdrawal phase preceded by a three month open label run-in
phase, designed with the goal of definitively establishing the durability of
the clinical benefits of NORTHERA, has been preliminarily agreed to with
the FDA . Based on the contemplated study design, the trial would include
approximately 1,400 patients, which the FDA has agreed may be enrolled
over a six year period. |
