|
S*P
发帖数: 7575 | 2 赌博的童鞋要小心了：
1/16 SNTS PDUFA
1/17 PATH PDUFA
1/21 IPXL PDUFA
1/23 HPTX PDUFA
1/27 FURX PDUFA
1/29 ISIS PDUFA
1/29 AEGR PDUFA
2/2 HEB PDUFA |
|
S*P
发帖数: 7575 | 3 赌博的童鞋要小心了：
1/16 SNTS PDUFA
1/17 PATH PDUFA
1/21 IPXL PDUFA
1/23 HPTX PDUFA
1/27 FURX PDUFA
1/29 ISIS PDUFA
1/29 AEGR PDUFA
2/2 HEB PDUFA |
|
y*****l
发帖数: 5997 | 4 Pre market up.
Spectrum Pharmaceuticals Announces Record Revenue and Record Profit in First
Quarter 2011
28 minutes ago - BIZ via Comtex
BusinessWire--Anticipate Reporting a Record Quarterly Profit in the First
Quarter 2011 Second Consecutive Profitable Quarter
--FUSILEV(R) sNDA For Use In Advanced Metastatic Colorectal Cancer is
Currently Under Review by the FDA PDUFA Action Date -- This Week -- April 29
, 2011
--ZEVALIN(R) Prior Approval Supplement for the Removal of the Bioscan
Requirement Cu... 阅读全帖 |
|
d******8
发帖数: 1972 | 5 好像没有什么影响。
http://finance.yahoo.com/news/amarin-reports-first-quarter-2012
BEDMINSTER, N.J., and DUBLIN, Ireland, May 8, 2012 (GLOBE NEWSWIRE) --
Amarin Corporation plc (Nasdaq:AMRN - News), a late-stage biopharmaceutical
company focused on cardiovascular disease, today announced financial results
for the quarter ended March 31, 2012 and provided an update on company
operations.
Amarin noted the following highlights since the quarter ended December 31,
2011:
Received Notice of Allowance for paten... 阅读全帖 |
|
e****1
发帖数: 207 | 6 来自主题: _pennystock版 - IMGG 很看好这只,希望能翻倍后FREE RUN等它的FDA结果而不是希望它不过后接飞刀.
分享一下自己摸索的BIO经验.
510(K)的因为没有固定PDUFA DATE还比较难捉摸.
那些有PDUFA DATE的比如10月份的ARNA,ALXA,AVNR,BIOD,ISTA最正确的操作是预先埋伏
,象今天开市就是个进场的好时机,然后补一个10月份的PUT,等差不多到PDUFA DATE的时
候肯定有不少RUN UP的了,卖掉一部分拿回本金那利润赌FDA结果,过了就翻几倍,不过那
PUT也会进帐不少然后还能捉准机会接飞刀赚个反弹随时也能翻倍.
希望对大家有用. |
|
y*****l
发帖数: 5997 | 7 Latest News Headlines for Spectrum Pharmaceuticals Incorporated
Spectrum Pharmaceuticals Board Approves Replacement of Stockholder Rights
Agreement
Tuesday 11/30/2010 7:00 AM ET - Businesswire
Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI) announced today that on
November 29, 2010 its Board of Directors met with its legal and financial
advisors to consider Spectrum Pharmaceuticals' current stockholder rights
agreement, which originally was adopted in 2000 and is scheduled to expire
on December ... 阅读全帖 |
|
b******h
发帖数: 777 | 8 这是个大牛股. 不知道为什么没有太多的人注意. 看来现在正好的BUY DIP 的时候. 如
果FDA 批准, 我的估计是股价应该在30-40之间.
ANALYSTS好象对它有很高的评价:
"XenoPort PDUFA date extension a net positive, says RBC Capital
RBC views the PDUFA date extension for XP-13512 as a net positive since it
believes expectations were very low and REMS is a minor issue, suggesting
FDA approval is likely. The firm expects shares to trade up on the news and
keeps an Outperform rating on the stock."
现在只有两星期的时间就到approval date.
Current target price: $31
Disclosures:我在18.5进了4K |
|
j*****7
发帖数: 4348 | 9 Zalbin的PDUFA是在十月四号， 没有人认为FDA会批； Benlysta的PDUFA是在十一月，
绝大多数人相信FDA会给过。
公司被收购的前景嘛， 我暂时不看好。 |
|
s********s
发帖数: 259 | 10 文学城抄来的。不管对否，觉得比较有水平。
投资预测和决策同等重要：一个SPPI实例
看到大家在楼下为“投资不是预测，而是决策”的帖子在热烈讨论、甚至争论，各方都
有一定道理，只
是各有所侧重而已。http://bbs.wenxuecity.com/finance/2452032.html
根据我最近1个多月做SPPI的实例，我认为股票投资，预测和决策同等重要。分析预测
是决策赢利的
前提，而决策赢利是分析预测的目的。
1. SPPI投资热点分析、预测及决策参考（策略）
来源: sunning 于 2011-03-22 01:29:13
http://bbs.wenxuecity.com/finance/2409490.html
（1） SPPI现金富裕, Approximately $104 Million。（Ref: 当前SPPI市值 $400
Million）
（2）两个治疗癌症的药品去年以来一直销售旺盛，利润可观。2010 Consolidated
Revenue
$74 Million。
（3）下个月4/29 SPPI - PDUFA Date for Fusilev sNDA... 阅读全帖 |
|
u********e
发帖数: 4950 | 11 ☆─────────────────────────────────────☆
sixdegrees (savvy woman wanna be) 于 (Sun May 1 00:29:58 2011, 美东) 提到:
文学城抄来的。不管对否，觉得比较有水平。
投资预测和决策同等重要：一个SPPI实例
看到大家在楼下为“投资不是预测，而是决策”的帖子在热烈讨论、甚至争论，各方都
有一定道理，只
是各有所侧重而已。http://bbs.wenxuecity.com/finance/2452032.html
根据我最近1个多月做SPPI的实例，我认为股票投资，预测和决策同等重要。分析预测
是决策赢利的
前提，而决策赢利是分析预测的目的。
1. SPPI投资热点分析、预测及决策参考（策略）
来源: sunning 于 2011-03-22 01:29:13
http://bbs.wenxuecity.com/finance/2409490.html
（1） SPPI现金富裕, Approximately $104 Million。（Ref: 当前SPPI市值 $400
Milli... 阅读全帖 |
|
t********t
发帖数: 5415 | 12 今天盘前差点到8了，中午左右到了5.7，现在回到6.4了。第一天taking profit的肯定
一把一把的，媒体消息还没跟上，等到周末几个大妈节目吹吹风，周一就上来了。ARNA
的PDUFA date比VVUS提前一个月，哪来的ARNA比VVUS后approve？AdCom说到底也只是“
建议”，批文还是要从FDA拿。但是有一点不能忽视：VVUS的PDUFA被延迟了3个月，这
个事个人觉得有40%左右的可能也发生在ARNA身上。ARNA的副作用研究需要大量新数据
（因为是新药），非要pre-marketing的时候搞研究的话一时半会搞不到那么多患者的
。 |
|
g****e
发帖数: 1426 | 13 HZNP is running like ARNA, will run to 7 as approach Pdufa date 07/26.
Dvax lower low and higher high, expecting FDA Announcement about NDA
acceptance next week. Just had dilution at 4.25 and Pdufa date 10/26. Don't
miss them, do you own DD. |
|
s******i
发帖数: 350 | 14 最近有公司药物PDUFA日子接近，我觉得大概被FDA批准的可能有一半的药，可能借此东
风，后面的药股会有些上升。现在买最近的待批药风险较大，觉得买十月份或以后的待
批药目前会便宜点，有利润可涂。CRTX 's PDUFA 在十月. 主席认为如何？什么价位买
入和卖出合适？ |
|
S*P
发帖数: 7575 | 15 既然开帖，就有始有终
PATH
PDUFA Date of January 17, 2013
CONSHOHOCKEN, PA--(Marketwire - Jul 31, 2012) - NuPathe Inc. (NASDAQ: PATH)
, a biopharmaceutical company focused on the development and
commercialization of branded therapeutics for diseases of the central
nervous system, today announced that the company's New Drug Application (NDA
) resubmission for its migraine patch (NP101) has been accepted for filing
by the U.S. Food and Drug Administration (FDA). NuPathe has received a
Prescription Drug User... 阅读全帖 |
|
g****e
发帖数: 1426 | 16 Current price: $2.97
Lymphoseek FDA decision target date: April 30th
NAVB got a CRL due to only manufacturing issues. These problems were fixed
before EU submission. So FDA approval could be earlier before PDUFA date.
The company is very optimistic on the approval. Per financial update PR on
12/11/2012: ".... prepare for Lymphoseek commercialization, as we
confidently anticipate US approval.”
Technically, it is in uptrend and tested $3 resistance level many times(
warrant exercise explained in a... 阅读全帖 |
|
g****e
发帖数: 1426 | 17 Current price: $2.97
Lymphoseek FDA decision target date: April 30th
NAVB got a CRL due to only manufacturing issues. These problems were fixed
before EU submission. So FDA approval could be earlier before PDUFA date.
The company is very optimistic on the approval. Per financial update PR on
12/11/2012: ".... prepare for Lymphoseek commercialization, as we
confidently anticipate US approval.”
Technically, it is in uptrend and tested $3 resistance level many times(
warrant exercise explained in a... 阅读全帖 |
|
d******5
发帖数: 4273 | 18 今天早上曾在鼓板发了个关于FDA药物审批日程的链接，供喜欢药股的同学参考，但此
贴很快被人删除了，不明原因。
其中包括PDUFA和委员会投票日期，会定期更新。如感兴趣，有关讨论可参考我的博客
文章：
http://mitbbs.org/pc/pccon_14439_321123.html
6月PDUFA
6/7/14 BDSI
6/10/14 OREX
6/16/14 NAVB
6/20/14 CBST
6/28/14 NPSP
提醒：
1、药股尤其是小药股追涨杀跌者，需要了解相关药物临床试验进展和FDA审批情况；
2、赌临床试验和FDA审批，风险巨大，要慎重！ |
|
j***u
发帖数: 836 | 19 前不久MRK买IDIX整出那么大的动静来。GILD也不过跌到79马上就回来了。
这次是SB俄勒冈政府和英国NICE还在考虑Insurance付账的事（SB们宁可付更高的住院
费和肝移植的费？）
我看再见到80以下的价很难了。
大家都想着76到78，MM会让你如意？
7月24日盘后Q2，然后9月10月好几个PDUFA （将要有更多像Sovaldi一样的Doorbuster
出来）。看看日历：
http://www.biopharmcatalyst.com/pdufa-calendar/
我感觉现在是MM在故意打压好低价进货。到十月涨到90多因该不成问题。风险几乎为0.
刚刚从MB上看到最新Sovaldi 处方数回升了：
Sovaldi scripts in week ending 6/6: TRx +14%. NRx +16%
Bouncing back to pre-Memorial Day levels
Q2 10有89又是个大BEAT |
|
发帖数: 1 | 20 28号宣布PEUFa结果
DVAX
$10.06
+0.46 (+4.73%) HEPLISAV-B
Hepatitis B
PDUFA 07/28/2017
CRL February 25, 2013 and November 14, 2016. New PDUFA August 10, 2017.
Advisory Committee Meeting July 28, 2017. |
|
发帖数: 1 | 21 二楼可拍砖
DVAX
$21.70
+1.45 (+7.16%) HEPLISAV-B
Hepatitis B
PDUFA 11/10/2017
CRL February 25, 2013 and November 14, 2016. Original PDUFA date set for
August 10, 2017 but noted August 3, 2017 a 3-month extension to August 10.
Advisory Committee Meeting July 28, 2017 voted 21 -1 in favor of
recommending approval. |
|
s**********8
发帖数: 25265 | 22 来自主题: MedicalDevice版 - FDA The Food and Drug Administration (FDA or USFDA) is an agency of the United
States Department of Health and Human Services, one of the United States
federal executive departments. The FDA is responsible for protecting and
promoting public health through the regulation and supervision of food
safety, tobacco products, dietary supplements, prescription and over-the-
counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals,
blood transfusions, medical devices, electromagnetic radiati... 阅读全帖 |
|
s**********8
发帖数: 25265 | 23 A Special Protocol Assessment (SPA) is a declaration from the Food and Drug
Administration that an uncompleted Phase III trial's design, clinical
endpoints, and statistical analyses are acceptable for FDA approval.
Three types of protocols related to PDUFA products are eligible for this
special protocol assessment under the PDUFA goals:[1]
1.animal carcinogenicity protocols,
2.final product stability protocols,
3.clinical protocols for phase 3 trials whose data will form the primary
basis for an... 阅读全帖 |
|
f**********g
发帖数: 2252 | 24 HGS and GlaxoSmithKline announce extension of PDUFA date for SLE drug
Monday 12/06/2010 9:47 AM ET - Datamonitor
Related Companies
Symbol Last %Chg
HGSI 25.95 1.37%
As of 10:18 AM ET 12/6/10
Human Genome Sciences, Inc., or HGS, and GlaxoSmithKline PLC have announced
that the FDA has extended the Prescription Drug User Fee Act, or PDUFA,
target date for its priority review of the Biologics License Application, or
BLA, for Benlysta as a potential treatment for systemic lupus erythematosus
from Dec... 阅读全帖 |
|
v**********m
发帖数: 5516 | 25 来自主题: _pennystock版 - sppi http://www.businesswire.com/news/home/20110421006626/en/Spectru
April 21, 2011 02:42 PM Eastern Daylight Time
Spectrum Pharmaceuticals Announces FDA Approval of FUSILEV®’s Ready-to
-Use Formulation (RTU)
* Until Now FUSILEV® Has Been Available Only As A Lyophilized
Product
* FUSILEV® sNDA For Use In Advanced Metastatic Colorectal Cancer is
Currently Under Review By The FDA
o PDUFA Action Date – April 29, 2011
* FUSILEV® Is Currently FDA Approved and Mark... 阅读全帖 |
|
s********s
发帖数: 259 | 26 【 以下文字转载自 Stock 讨论区 】
发信人: sixdegrees (savvy woman wanna be), 信区: Stock
标 题: (ZT)投资预测和决策同等重要：一个SPPI实例
发信站: BBS 未名空间站 (Sun May 1 00:29:58 2011, 美东)
文学城抄来的。不管对否，觉得比较有水平。
投资预测和决策同等重要：一个SPPI实例
看到大家在楼下为“投资不是预测，而是决策”的帖子在热烈讨论、甚至争论，各方都
有一定道理，只
是各有所侧重而已。http://bbs.wenxuecity.com/finance/2452032.html
根据我最近1个多月做SPPI的实例，我认为股票投资，预测和决策同等重要。分析预测
是决策赢利的
前提，而决策赢利是分析预测的目的。
1. SPPI投资热点分析、预测及决策参考（策略）
来源: sunning 于 2011-03-22 01:29:13
http://bbs.wenxuecity.com/finance/2409490.html
（1） SPPI现金富裕, Approximately $104 ... 阅读全帖 |
|
y*****l
发帖数: 5997 | 27 这篇文章不错, 刚稀释过,钱还够烧一阵.看图形也不错,盘小,可以少量埋伏.
请生物专家们补充.
http://finviz.com/screener.ashx?v=341&t=ALXA
Alexa Pharmaceuticals (ALXA) Market Cap $102.4 Million 05/13/11 at 1.42 PPS
Alexa received its CRL on October 11, 2010 for its lead product, AZ-004, for
reducing agitation in patients with schizophrenia or bipolar disorder. The
active ingredient in their Staccato device that emits an aerosol spray to be
inhaled by the patient is loxapine, a drug already approved for use as an
antipsychotic medication. Th... 阅读全帖 |
|
v**********m
发帖数: 5516 | 28 http://seekingalpha.com/article/270094-biotech-some-crl-recipie
Alexa Pharmaceuticals (ALXA) Market Cap $102.4 Million 05/13/11 at 1.42 PPS
Alexa received its CRL on October 11, 2010 for its lead product, AZ-004, for
reducing agitation in patients with schizophrenia or bipolar disorder. The
active ingredient in their Staccato device that emits an aerosol spray to be
inhaled by the patient is loxapine, a drug already approved for use as an
antipsychotic medication. The two Phase III trials leadin... 阅读全帖 |
|
v**********m
发帖数: 5516 | 29 Arna pump新文。
http://seekingalpha.com/article/292994-is-arena-s-lorcaserin-on
Is Arena's Lorcaserin On Track For Approval In 2012?
28 comments | by: KLLJ Investments September 12, 2011 | about: ARNA
Arena Pharmaceuticals (ARNA) investors have had a tough road over the last
12 months since a negative vote by an Advisory Committee called to review
Arena’s lead drug candidate for the treatment of obesity – lorcaserin. The
stock was trading close to $7.00 a year ago heading into that fateful
Advis... 阅读全帖 |
|
v**********m
发帖数: 5516 | 30 http://seekingalpha.com/article/894061-delcath-systems-an-exclu
Delcath Systems: An Exclusive Interview With ROTH Capital Senior Analyst
September 28, 2012 | about: DCTH
Disclosure: I am long DCTH. (More...)
Today I have the pleasure of publishing an exclusive interview that took
place this week between me and one of the leading senior analysts for
medical technology, Mr. Matt Dolan of ROTH Capital Partners. Mr. Dolan has
followed the industry for nearly a decade and has been the senior analys... 阅读全帖 |
|
l******5
发帖数: 3030 | 31 Contact the recruiter directly please
Principal Research Scientist-PK/PD- Indiana -
The Principal Research Scientist functions as a project leader in a
multidisciplinary team environment with primary responsibility for the early
preclinical development of antibodies and protein molecules.
KEY OBJECTIVES/DELIVERABLES:
- Integrate pharmacokinetics and PK/PD with discovery biology to define
structure activity relationships to guide protein engineering strategies and
to help optimize development of ... 阅读全帖 |
|
j*****7
发帖数: 4348 | 32 Below are 12 extreme FDA trades for 11 companies with market caps below $
200M which have pending new drug product decisions or other meetings/
milestones scheduled with the FDA that are expected to have a major impact
on each of the underlying stock prices as the PDUFA decision dates approach
and the decision is ultimately announced. A high risk/reward trading
approach to consider for speculative traders is investing a small amount of
money that you can afford to lose in a basket of stocks incl |
|
E***X
发帖数: 885 | 33 The MAA is the second major regulatory filing by InterMune to seek approval
to market pirfenidone for the treatment of patients with IPF. The New Drug
Application (NDA) for pirfenidone was filed by InterMune in the United
States in early November 2009. The U.S. Food and Drug Administration's (FDA)
Pulmonary-Allergy Drugs Advisory Committee (PADAC) is scheduled to discuss
the company's NDA for pirfenidone on March 9, 2010. Based on the
Prescription Drug User Fee Act (PDUFA), the FDA has set an ac |
|
c****x
发帖数: 127 | 34 "２周内有FDA 决定的药股不能参赛。" ITMN has FDA PDUFA date of 5/4. |
|
z*****8
发帖数: 132 | 35 “Human Genome Sciences And GlaxoSmithKline plc Announces FDA Extension of
BENLYSTA PDUFA Target Date To March 10, 2011”
完了。。。。 |
|
T**M
发帖数: 658 | 36 PDUFA date is Jan 22, right? |
|
f*********8
发帖数: 130 | 37 CORRECTION ON $SPPI - approval for new formulation, sNDA for new indication
still pending w/ 29-Apr pdufa |
|
n**********8
发帖数: 340 | 38 老牛看好ais吗？ 他明天有pdufa?
thanks! |
|
l**********y
发帖数: 2050 | 39 ☆─────────────────────────────────────☆
KeepBuying (雁过留声) 于 (Wed Dec 7 10:47:38 2011, 美东) 提到:
AMRN, IMGN, ARIA.
医药股风险大哦，小心哦。亏了别找我，赢了也别给我发包子
☆─────────────────────────────────────☆
dayandnig1 (蝶来风有致) 于 (Wed Dec 7 11:09:53 2011, 美东) 提到:
铁牛有啥分析，分享一下呗
☆─────────────────────────────────────☆
KeepBuying (雁过留声) 于 (Wed Dec 7 11:17:03 2011, 美东) 提到:
AMRN，大家都知道哦，AMR101，主要用于心脏病的，效果很好。唯一的缺点是Patent没
申请下来的问题。不过药明年被FDA批准的问题不是太大。
IMGN，很好，药TP，癌症的福音，估计批准的可能性极大。明年应该会申请NDA
ARIA，癌症药，几次的临床效果都不错。明年应该会... 阅读全帖 |
|
c*******d
发帖数: 353 | 40 Their lib-gel female viagra failed, that's true. But they still have a
couple of potential drugs:
Cancer in pipeline:
They have an upcoming T gel waiting for PDUFA date feb 14, 2012. This is a
partner product with TEVA with 5 mil license fee & royalty.
Well, it's still got some juice, I think. |
|
d******8
发帖数: 1972 | 41 February 13, 2012 8:10 AM EST
Amarin Corporation plc (Nasdaq: AMRN) announced today that it was informed
by the U.S. FDA that no advisory committee meeting will be scheduled in
connection with the FDA's review of the NDA seeking approval for the use
AMR101 in the treatment of patients with very high triglycerides (≥500mg/dL
), the company's lead product candidate. The FDA has previously assigned a
Prescription Drug User Fee Act (PDUFA) date of July 26, 2012 for completion
of its review of the AM... 阅读全帖 |
|
g****e
发帖数: 1426 | 42 On 06/21 when HZNP was under $5 I called to buy, a few days later it reached
$7 with huge return.
Now all money from ARNA are reinvested in HZNP and ready for the next run-up
to $9 before PDUFA date 07/26.
Do you own DD on the NDA, and double digits increasing sales of new FDA
approval drug DUEXIS, Analyst coverage and current market cap.
Welcome any comments and enjoy trading!!
If you followed my call last call and made huge money, please comment here
if you are going to buy back shares for the... 阅读全帖 |
|
g****e
发帖数: 1426 | 43 I bought back today at $6.2 which I think was a good entry point. Still not
late if you think all the money from ARNA. All is about hypes around PDUFA
date 07/26 which I think HZNP will a very favor recommendation from the
advisory panel. |
|
S*********t
发帖数: 620 | 44 July has some other drugs waiting for PDUFA decision, any comments for those
? For example, PGNX didn't get much boosted like HZNP. |
|
S*********t
发帖数: 620 | 45 I am also watching a penny stock TLON. PDUFA date: 08/12. Both price and
volume started increasing recently ... |
|
g****e
发帖数: 1426 | 46 Don't hold your shares if you don't feel comfortable with.
I am currently holding 1000 shares of HZNP which I bought at $6.2. I believe
the company and it's products and 07/26 PDUFA catalyst.
Next week is very critical, I will sell them on Thursday if the price goes
up to my target or at least upper 8s. Otherwise, I will hold it and consider
a mid term investment. Also please note that HZNP will have EU approval
decison in August. BTW, I am not dt and don't care about too much daily drop
and gai... 阅读全帖 |
|
g****e
发帖数: 1426 | 47 Bought it today. Great buying opportunity. It has cash more then $100m, and
Pdufa next January. Don't miss it!!!!! |
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g****e
发帖数: 1426 | 48 Due to the high risk and reward, it is hard to resist to gamble. But never
play up and down like MM!! Since MM have insider knowledges and huge funds
to manipulate share price! The only advantage we have is time. We know the
FDA decision event is coming and should buy these stocks
When the price is low ahead of time! The price will eventually go up when
the catalyst event is approaching and then we sell for gains.
Currently I have long position on AMRN, DCTH, AEGR & DVAX. Among these 4,
AMRN is ... 阅读全帖 |
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m********m
发帖数: 99 | 49 I long Impax (IPXL). Endo just got rejected by the court for trying to stop
the introduction of tempering-resistance Opana ER. Impax also waits for a
decision on its Parkinson's disease treatment and PDUFA date is late January
. The best of all. the company is making money and has over $300 Million on
its balance. Allen Chao is also sitting on its board, for those who don't
know who Allen Chao is, he is the co-founder of Watson Pharmaceuticals. |
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g****e
发帖数: 1426 | 50 Current price: $17
Catalyst evetn: Leerink Swann Global Healthcare Conference 2:30 p.m. ET on
Thursday, February 14, 2013
Its price is at Bottom with two more catalyst events:
1. Auxilium's drug Xiaflex for indication Frozen Shoulder Phase IIa. Top-
line data due in the first quarter of 2013.
2. Xiaflex indication for Dupuytren's disease have PDUFA on 09/06/2013.
Do your own DD before investing. Good luck!! |
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