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t*******o
发帖数: 1464 | 1 赌博股。
八月中旬之前， 是否进fast track出结果。公司就这么一个三期的药。其他的都early
stage.
ADLS: Turning things around
Posted by Patrick On Saturday, July 31, 2010 0 comments
It appears that after several months of decline, Advanced Life Sciences Inc.
(OTC:ADLS.OB) appears to be headed in a positive direction. Recent
developments in the Restanza(tm) pipeline are now starting to show their
potential and have given investors a peek at their future. The more recent
news follows on the heels of their initial conversations back in March 2010
with the FDA about a Special Protocol Assessment for Restanza(TM) in
outpatient community acquired bacterial pneumonia (CABP). They are also
hoping to use Restanza for biodefense indications, such as anthrax, plague
and tularemia. Additionally, they recently raised $3 million and they
entered into a debt for equity exchange with its chairman and CEO Michael T.
Flavin for $2 million.
We are really intrigued by the more recent PR’s concerning Restanza and the
FDA. More recently(6/30/2010), ADLS submitted a final Special Protocol
Assessment (SPA) with the FDA for the proposed Phase III clinical program of
Restanza. Michael T. Flavin, Ph.D., Chairman and CEO of Advanced Life
Sciences stated, “Based on the FDA's SPA review cycle, we expect a reply to
our submission by mid-August of this year.”
Today’s news falls in line with the positive direction that ADLS has set
out for itself. They have applied for Fast-Track Designation for Restanza(TM
), for the treatment of community acquired bacterial pneumonia (CABP). FDA
will review the request and make a decision within sixty days based on
established criteria. This certainly has a lot of advantages for ADLS
shareholders and the Restanza pipeline. Namely,
1. More frequent meetings and correspondence with FDA to discuss the drug
’s development plan, trial design and ensure collection of appropriate data
needed to support drug approval
2. Eligibility for Accelerated Approval, i.e., approval on an effect on a
surrogate, or substitute endpoint reasonably likely to predict clinical
benefit,
3. Rolling Review, which means that a drug company can submit completed
sections of its New Drug Application (NDA) for review by FDA, rather than
waiting until every section of the application is completed before the
entire application can be reviewed.
Investors should remember that when KERX landed Fast-Track designation for
Perifosine back in April, it sent their shares on a 1-2 month bull-run. If
ADLS lands Fast-Track Status and a SPA, this would be a big deal for them
and would certainly increase their valuation.
At the $0.05 level, we don’t foresee too much downside risk, maybe 10-15%.
With several potential news catalysts and developments over the next 1-2
months, ADLS has a bullish rating going forward. We believe Fast-Track
Status and a SPA could push them back to the $0.20-30 levels, since these
designations provide a much clearer picture for the approval pathway of
Restanza. We look forward to watching Advanced Life Sciences over the next
several months. | t*******o
发帖数: 1464 | 2 equity exchange：CEO 不久前 $0.042 吃了2m 普通股。 | g******0
发帖数: 1165 | 3 这个股我去年4月份就听胡同的那个Xtrader题过 当时他一直坚持加仓 貌似几M股有了
吧 愣是从几毛变成现在的几分
它的药如何？？有没有个奔头？？
麻烦主席和google2005来看看这个penny股的走势如何??
early
Inc.
2010
【在 t*******o 的大作中提到】
: 赌博股。
: 八月中旬之前， 是否进fast track出结果。公司就这么一个三期的药。其他的都early
: stage.
: ADLS: Turning things around
: Posted by Patrick On Saturday, July 31, 2010 0 comments
: It appears that after several months of decline, Advanced Life Sciences Inc.
: (OTC:ADLS.OB) appears to be headed in a positive direction. Recent
: developments in the Restanza(tm) pipeline are now starting to show their
: potential and have given investors a peek at their future. The more recent
: news follows on the heels of their initial conversations back in March 2010
| m*********y
发帖数: 10616 | 4 量太小且涨幅不明显，我是不会介入的。
early
Inc.
2010
【在 t*******o 的大作中提到】
: 赌博股。
: 八月中旬之前， 是否进fast track出结果。公司就这么一个三期的药。其他的都early
: stage.
: ADLS: Turning things around
: Posted by Patrick On Saturday, July 31, 2010 0 comments
: It appears that after several months of decline, Advanced Life Sciences Inc.
: (OTC:ADLS.OB) appears to be headed in a positive direction. Recent
: developments in the Restanza(tm) pipeline are now starting to show their
: potential and have given investors a peek at their future. The more recent
: news follows on the heels of their initial conversations back in March 2010
| b*****h
发帖数: 783 | 5 FDA要求他们做两个clinical trail来比较Restanza和目前市场上的macrolid
antibiotic比较治疗CABP的效果，很严竣的任务。他们cash不够，大概会大量稀释股票
融资，目前clinical trial还没开始，感觉前途不定。
early
Inc.
2010
【在 t*******o 的大作中提到】
: 赌博股。
: 八月中旬之前， 是否进fast track出结果。公司就这么一个三期的药。其他的都early
: stage.
: ADLS: Turning things around
: Posted by Patrick On Saturday, July 31, 2010 0 comments
: It appears that after several months of decline, Advanced Life Sciences Inc.
: (OTC:ADLS.OB) appears to be headed in a positive direction. Recent
: developments in the Restanza(tm) pipeline are now starting to show their
: potential and have given investors a peek at their future. The more recent
: news follows on the heels of their initial conversations back in March 2010
| g******0
发帖数: 1165 | 6 谢谢
【在 b*****h 的大作中提到】
: FDA要求他们做两个clinical trail来比较Restanza和目前市场上的macrolid
: antibiotic比较治疗CABP的效果，很严竣的任务。他们cash不够，大概会大量稀释股票
: 融资，目前clinical trial还没开始，感觉前途不定。
:
: early
: Inc.
: 2010
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| 相关主题 |
|---|
| ● SNTS玩FDA pre-run? | ● kerx failed phase III | | ● 7月份药股FDA,NDA,试验数据公布时间表——7/15-7/31 | ● 每日股票分析5月16－－AEZS《案例分析》 | | ● 8月份药股FDA,NDA,试验数据公布时间表 | ● 癌症药太牛了 | | ● 9月份药股FDA,NDA,试验数据公布时间表 | ● 一个小生拉AEZS | | ● KERX up 18% BH | ● Extreme FDA Calendar Trades: 21 Stocks Under $5 | | ● [合集] Biotech Stocks Facing FDA NDA Clinical Trial Data | ● 4月份药股FDA,NDA,试验数据公布时间表 | | ● Re: 2012年的明星医药股，大家别错过哦 (转载) | ● 关于FDA与bio，看bio sector的精华区 | | ● kerx 看起来很有炒点。 | ● 6月份药股FDA,NDA,试验数据公布时间表 |
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