a*****h
发帖数: 484 | | a*****h
发帖数: 484 | 2 It's doing very well today!
【在 a*****h 的大作中提到】
: 大家来关注一下。。
| w***y
发帖数: 2537 | | g***y
发帖数: 1025 | 4 Aastrom is a late-stage clinical company dealing with stem cell technology.
The company is targeting orphan cardiovascular indications in critical limb
ischemia (CLI) and dilated cardiomyopathy (DCM). Aastrom (ASTM) already has
Phase II B clinical data that is statistically significant in a large phase
II clinical trial. Also, the company already has a scaleable, automated,
cell manufacturing facility and clear, developed regulatory paths forward as
a result of the drug Provenge being recently approved. That was another
autologous cell therapy product that was approved in April by the FDA.
CLI and DCM represent large, addressable market opportunities using Aastrom'
s stem cell research. The advantages of the company's therapy is that it has
already demonstrated therapeutic effects as a result of its large Phase II
clinical study. It is an autologous therapy where Aastrom starts with a
patient's own cells- so it is safe and simple. Aastrom only uses 50 ml of a
patient’s blood marrow, making it a simple procedure. Aastrom has treated
over 400 patients without a treatment-related adverse event. The company
also has a proprietary technology, so there is no risk of generic
competition.
Four significant events have occurred within the past few weeks with more
set to come in November. The most recent were:
On Oct 18th, Aastrom announced that the U.S. Food & Drug Administration (FDA
) granted fast track designation for the company’s critical limb ischemia (
CLI) cell therapy development program. Aastrom plans to initiate Phase 3
clinical testing of its treatment for CLI in early 2011. Source
On Oct 21st, Aastrom submitted to the U.S. Food and Drug Administration (FDA
) a special protocol assessment (SPA) describing the company's proposed
Phase 3 clinical development program in critical limb ischemia (CLI). If the
FDA concurs with the protocols outlined in the SPA, Aastrom expects to
initiate the Phase 3 program in early 2011. Source
On Oct 25th, Aastrom announces that the Former Chief Scientific Officer of
Warner-Lambert and President of Parke-Davis Pharmaceutical Research is to
join Aastrom's Board of Directors. Source
On Oct 26th, Aastrom announced that it has formed a Strategic Manufacturing
and Development Partnership with ATEK Medical. Source
Future key catalysts that could drive share price appreciation in the month
of November are:
ASTM webcast on Nov 2nd at Oppenheimer Conference: Aastrom's presentation
will take place at 12 PM ET on November 2, 2010.
ASTM VEITH symposium.. "RESTORE-CLI Trial Update: Ask the Experts" on 11-18-
10. Link
Late November/early December, the company should hear back from the FDA with
a response on its SPA submission. Aastrom hopes to have the SPA completed
by the FDA in the early first quarter (mid-January) of 2011. | g***y
发帖数: 1025 | 5 Bio太大起大落了，我一般不敢碰，懂行的来说说吧。 | a*****h
发帖数: 484 | 6 希望大家赚到钱啦!
【在 w***y 的大作中提到】
: 很牛呀
| K**********r
发帖数: 2640 | 7 这个太牛了，开盘就4％了，弄得我又不敢上了，眼睁睁看它飞了。。。 |
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