D****u
发帖数: 162 | 1 Spectrum Pharma affirms strong patent protection for FUSILEV through
December 31, 2019.
Co affirmed today that the FDA has granted FUSILEV "Orphan Drug" exclusivity
for use in combination chemotherapy with 5-fluorouracil in the palliative
treatment of patients with advanced metastatic colorectal cancer. In
addition, FUSILEV therapeutic compositions are protected under a US Patent
which expires at the end of December 2019. This is a composition of matter
patent claiming a therapeutically effectiv... 阅读全帖 |
|
b*****h
发帖数: 783 | 2 别烧，不清楚fusilev的patent，但从application到批很耗时。而且本来fusilev有
generic similar。dip感觉是机会。 |
|
v**********m
发帖数: 5516 | 3 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 |
|
y*****l
发帖数: 5997 | 4 sppi 最近要炒FDA吗？
Spectrum Pharmaceuticals Responds to FDA's Complete Response Letter for
Fusilev
Sunday 11/07/2010 1:04 AM ET - Close-up Media
Spectrum Pharmaceuticals, a biotechnology company with fully integrated
commercial and drug development operations with a primary focus in oncology,
announced that on Friday, October 29, it submitted a complete response to
the "Complete Response" letter issued by the U.S. Food and Drug
Administration (FDA), regarding its supplemental New Drug Application (s... 阅读全帖 |
|
f**********g
发帖数: 2252 | 5 FDA Accepts for Review Spectrum's Response on Fusilev as a Class 2
Submission
Thursday 12/02/2010 1:25 AM ET - Close-up Media
Related Companies
Symbol Last %Chg
SPPI 4.85 2.54%
As of 11:43 AM ET 12/3/10
Spectrum Pharmaceuticals, a biotechnology company with fully integrated
commercial and drug development operations with a primary focus in oncology,
announced that the U.S. Food and Drug Administration (FDA) has accepted for
filing and review the complete response regarding its supplemental New D... 阅读全帖 |
|
f**********g
发帖数: 2252 | 6 FDA Accepts for Review Spectrum's Response on Fusilev as a Class 2
Submission
Thursday 12/02/2010 1:25 AM ET - Close-up Media
Related Companies
Symbol Last %Chg
SPPI 4.85 2.54%
As of 11:40 AM ET 12/3/10
Spectrum Pharmaceuticals, a biotechnology company with fully integrated
commercial and drug development operations with a primary focus in oncology,
announced that the U.S. Food and Drug Administration (FDA) has accepted for
filing and review the complete response regarding its supplemental New D... 阅读全帖 |
|
y*****l
发帖数: 5997 | 7 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 |
|
s********s
发帖数: 259 | 8 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 | 9 ☆─────────────────────────────────────☆
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 |
|
s********s
发帖数: 259 | 10 【 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 |
|
b*****h
发帖数: 783 | 11 最近sppi比较热门，简单总结一下sppi的基本面。
sppi 是一家开发抗肿瘤药物的biotech，已经有两个产品在marketing
Fusilev for treatment of osteosarcoma
ZEVAlin for treatment of NHL
sppi 还有Apaziquone 用来治疗bladder cancer,
目前正在进行两个phase3 clinical trials.
(大概估计要2012年才能出结果）
公司还有一些其它处在clinical test早期的drug candidates。
公司的marketing情况对目前公司的价值起主导作用。
ZEVALIN 的salevs在慢慢增长，但总revenue还是比较小（4q of 2010, 9M).
FUSILEV的marketing 比较有意思。
上市后卖的量一直很小，不过最近一个季度(4q 2010)却猛增到23M. 是上一季度的几乎
4倍
这个突然增长是因为最近leucovorin供应不足。
leucovorin是用来治疗colorectal cancer 的generic drug。而F... 阅读全帖 |
|
b*****h
发帖数: 783 | 12 来自主题: _pennystock版 - SPPI 这次sppi 被AF 的那个报道迷惑了一下。
sppi 目前大部分value 来自fusilev. fusilev 本身没什么特别优势。 fusilev 卖的
好完全的起因是它的generic 生产短缺。
目前generic 供应在逐步恢复，所以，很自然会觉得fusilev 未来sale 没什么前景.
而这个negative 的不确定一直存在。
这次sale 56.6M 基本进入flat 平台，低于wk 预测。
sppi 花了大力气开拓zevalin市场，但是zevalin和rituxan 比有明显缺点，能否成功
要看head to head 试验和它的market 能力，这一点很不确定。sppi 其他pipeline 比
较早期，
目前这个价格不贵，但是negative 东西比较多，除非跌到特别便宜，不然还是考虑其
它的吧。。 |
|
y*****l
发帖数: 5997 | 13 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 |
|
y*****l
发帖数: 5997 | 14 Date Company Name Ticker Drug Event Outcome Details
04/30/2011 GlaxoSmithKline PLC GSK, GSK.L Lamictal-XR (sNDA) FDA
decision on Lamictal-XR for conversion to monotherapy for treatment of
partial seizures FDA approved Lamictal XR for conversion to monotherapy
for treatment of partial seizures on Apr.25
-Drug Status
-Approved in Other Countries
04/29/2011 Spectrum Pharmaceuticals Inc SPPI Fusilev (sNDA) FDA
action on Fusilev for additional use in c... 阅读全帖 |
|
O**I
发帖数: 776 | 15 【 以下文字转载自 pennystock 俱乐部 】
发信人: OSCI (TX), 信区: pennystock
标 题: FDA Drug Approvals in 2011
发信站: BBS 未名空间站 (Sat Jan 8 17:29:50 2011, 美东)
http://www.thestreet.com/story/10944267/1/biotech-calendar-fda-
BOSTON (TheStreet) -- An early Christmas present for biotech investors: The
first (overstuffed) FDA drug approval calendar of 2011.
More from Adam Feuerstein
Dendreon Bringing Provenge to EuropeBiotech Stock Mailbag: Best Stocks to
Watch in '11Merck Beats Vertex to FDA Hep C Filing
Market Activity
... 阅读全帖 |
|
f*******1
发帖数: 1308 | 16 它们卖得最好的一个药刚吃官司了。估计要去5刀以下走走了，本来就费了九牛二虎之
力刚把底部建好，现在要建地下室了。
A Nevada court has ruled claims 1 and 2 of Spectrum Pharma's (NASDAQ:SPPI) '
829 patent, which covers its Fusilev cancer drug, are invalid. Spectrum had
sued generic drugmaker Sandoz for allegedly infringing the claims.
The court has also denied Spectrum's request for an order declaring the
effective date of the approval of Sandoz's application for a generic version
of Fusilev won't be earlier than the expiration of the '829 patent.
Spectr... 阅读全帖 |
|
b*****h
发帖数: 783 | 17 SPPI的重头产品Apaziquone的三期结果要2012年才出来，
sppi 目前有两个药在卖，目前的revenue还不大，不过正处于增长的趋势，能增加到多
少不太清楚。
FDA 2009年批准了ZEVALIN的扩展用途，这个会在后面的sale中体现出来，
FUSILEV的sNDA FDA会在2011年四月底给结果，如果批准，那也会增加FUSILEV的sale,
sppi目前应该风险不大，增长点主要来自这两个药的revenue，但这个需要时间。 |
|
O**I
发帖数: 776 | 18 http://www.thestreet.com/story/10944267/1/biotech-calendar-fda-
BOSTON (TheStreet) -- An early Christmas present for biotech investors: The
first (overstuffed) FDA drug approval calendar of 2011.
More from Adam Feuerstein
Dendreon Bringing Provenge to EuropeBiotech Stock Mailbag: Best Stocks to
Watch in '11Merck Beats Vertex to FDA Hep C Filing
Market Activity
Orexigen Therapeutics Inc.| OREX
DOWN
Dendreon Corporation| DNDN
InterMune Inc.| ITMN
For easy reference, I've organized this regulatory ... 阅读全帖 |
|
O**I
发帖数: 776 | 19 http://www.thestreet.com/story/10944267/1/biotech-calendar-fda-
BOSTON (TheStreet) -- An early Christmas present for biotech investors: The
first (overstuffed) FDA drug approval calendar of 2011.
More from Adam Feuerstein
Dendreon Bringing Provenge to EuropeBiotech Stock Mailbag: Best Stocks to
Watch in '11Merck Beats Vertex to FDA Hep C Filing
Market Activity
Orexigen Therapeutics Inc.| OREX
DOWN
Dendreon Corporation| DNDN
InterMune Inc.| ITMN
For easy reference, I've organized this regulatory ... 阅读全帖 |
|
w*******0
发帖数: 13 | 20 BOSTON (TheStreet) -- An early Christmas present for biotech investors: The
first (overstuffed) FDA drug approval calendar of 2011.
For easy reference, I've organized this regulatory calendar in chronological
order based on the drug approval decision date. I've also included
information on pending FDA advisory panels. At the end of the calendar is a
list of companies with potential regulatory milestones in 2011 based on
expected but not yet completed drug approval filings.
In all, this calendar ... 阅读全帖 |
|
w*******0
发帖数: 13 | 21 BOSTON (TheStreet) -- An early Christmas present for biotech investors: The
first (overstuffed) FDA drug approval calendar of 2011.
For easy reference, I've organized this regulatory calendar in chronological
order based on the drug approval decision date. I've also included
information on pending FDA advisory panels. At the end of the calendar is a
list of companies with potential regulatory milestones in 2011 based on
expected but not yet completed drug approval filings.
In all, this calendar ... 阅读全帖 |
|
y*****l
发帖数: 5997 | 22 http://www.thestreet.com/story/11016605/1/biotech-calendars-201
By Adam Feuerstein 02/22/11 - 07:36 AM ES
Stock quotes in this article:HGSI, OPTR, XNPT, SPPI, DRRX, PATH
BOSTON (TheStreet) -- I've updated the 2011 FDA drug approval calendar.
For easy reference, I've organized this regulatory calendar in chronological
order based on the drug approval decision date. I've also included
information on pending FDA advisory panels. At the end of the calendar is a
list of companies with potential regul... 阅读全帖 |
|
X*****s
发帖数: 2767 | 23 Fusilev is, in fact, non-inferior to generic leucovorin.
it is likely the US regulators will finally approve Fusilev for mCRC in the
US.
这些用词都很模糊，哪里能查到具体的trial data? |
|
y*****l
发帖数: 5997 | 24 希望SPPI和XNPT一样，过了也大涨。
Xenoport(XNPT_) and GlaxoSmithKline(GSK_)
Drug/indication: Horizant for restless leg syndrome
Approval decision date: April 6, 2011
This is the second FDA review cycle for Horizant. The original new drug
application was filed to FDA in January 2009.
Spectrum Pharmaceuticals(SPPI_)
Drug/indication: Fusilev for colon cancer
Approval decision date: April 29, 2011
This is the second review for Fusilev in colon cancer. The drug is already
approved as a treatment for a form of bon... 阅读全帖 |
|
y*****l
发帖数: 5997 | 25 来自主题: _pennystock版 - SPPI Spectrum Pharmaceuticals Announces ZEVALIN(R) and Belinostat Abstracts to Be
Presented at the American Society of Clinical Oncology Annual Meeting
4 hours 16 minutes ago - BIZ via Comtex
BusinessWireSpectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology
company with fully integrated commercial and drug development operations
with a primary focus in oncology, today announced ZEVALIN(R) (ibritumomab
tiuxetan) and Belinostat abstracts will be presented at the 2011 Annual
Meeting of the American... 阅读全帖 |
|
b*****h
发帖数: 783 | 26 sppi 现在position很强，以前担心FUSILEV的sale会在generic 恢复供应时大受影响，
现在情况相反，
第三季度的FUSILEV的sale已经增加到41M, sppi 的revenue 如能稳定在200m/year, 那
它的cap至少要1b。 |
|
b*****h
发帖数: 783 | 27 be careful about that, most current value of sppi is coming from the sales
of Fusilev. If there is any sign of dropping of Fusilev's sale, SPPI price
will tank a lot.
once |
|
b*****h
发帖数: 783 | 28 来自主题: _pennystock版 - SPPI AF 说了Fusilev 6月的销量，如果这个数据确切，那Fusilev 地位基本确立。
SPPI 被严重低估。。 |
|
b*****h
发帖数: 783 | 29 来自主题: _pennystock版 - SPPI 这个基本不用赌， 他的sale 一定增加，只是增加多少的问题。
fusilev 能买好完全是sppi 的运气。如果六月份sale 真是double了，说明fusilev 市
场占有率很高了。
赚钱的公司股价跌不下去的。。 |
|
b*****h
发帖数: 783 | 30 来自主题: _pennystock版 - SPPI longer 和 shorter 在sppi 上正在准备对决。
sppi 的short rate 已经接近50％。 支持shorter 的信念就是fusilev 的sale 会在
generic 供应恢复后迅速下降，但在过去的一年一直延续到现在，fusilev的销量再不
断增加。
SPPI 要正真能进multiple B 的行列，核心还是看他能否将Zevalin 进行逆转。 |
|
b*****h
发帖数: 783 | 31 来自主题: _pennystock版 - SPPI 总体情况没变，brand 药理论上是搞不过generic药的。中短期看空的占多数。但
fusilev 失利还没有成事实，所以要看下一个er. 目前long 短期的risk 比较大。 长
期的话， sppi cash 比较足，pipeline 也比较丰富，Zevalin, 和他最近买回来的
anth 也许会成功，但是这个概率不大。如果他能把zevalin 做大，那这个公司就强大
了。
最好等大家把fusilev 这个negative future 的东西discount 掉，再看有么有机会。。 |
|
D******9
发帖数: 2665 | 32 SPPI 现在有两个产品在销售， 其中Zevalin是用于治疗淋巴癌，这个药以前用于治疗
复发或是对其它药不敏感的非霍奇金淋巴瘤， 去年夏天FDA批准用于新病人的治疗，
所以它的销量应该会上升， 但是非霍奇金淋巴瘤并不是常见的肿瘤， 所以他家从这个
药应该挣不到太多的钱， 另外这个药有射线， 用起来会比较麻烦。 另一个药Fusilev
现在可以忽略不计。
但是它现在有另一个用于治疗膀胱癌的药在进行三期临床实验，膀胱癌在美国一年就有
差不多10万新病人， 其它几个药厂已经给它一些PRE-PAYMENT， 一旦它能通过三期临
床， 它就发了。 我觉得它会被收购。
The next tentative earnings announcement is expected on 03/29/2010.
个人认为短期目标可以到6-7块，要是通过三期临床， 至少翻倍。 |
|
D******9
发帖数: 2665 | 33 SPPI 现在有两个产品在销售， 其中Zevalin是用于治疗淋巴癌，这个药以前用于治疗
复发或是对其它药不敏感的非霍奇金淋巴瘤， 去年夏天FDA批准用于新病人的治疗，
所以它的销量应该会上升， 但是非霍奇金淋巴瘤并不是常见的肿瘤， 所以他家从这个
药应该挣不到太多的钱， 另外这个药有射线， 用起来会比较麻烦。 另一个药Fusilev
现在可以忽略不计。
但是它现在有另一个用于治疗膀胱癌的药在进行三期临床实验，膀胱癌在美国一年就有
差不多10万新病人， 其它几个药厂已经给它一些PRE-PAYMENT， 一旦它能通过三期临
床， 它就发了。 我觉得它会被收购。
The next tentative earnings announcement is expected on 03/29/2010.
个人认为短期目标可以到6-7块，要是通过三期临床， 至少翻倍。 |
|
s*********s
发帖数: 318 | 34 治疗膀胱癌的药过的可能性多大？去年那个药没过，把ＳＰＰＩ搞掺了．
Fusilev |
|
l***u
发帖数: 294 | 35 谢谢分析，不知道版上还有多少兄弟拿着SPPI，如果现在要进一定要记得在FDA审批之
前抛掉，不然风险太大了。
Fusilev |
|
|
|
|
h***e
发帖数: 7320 | 39 我们开个主题，肥猪和哈密我每天更新，希望大家能找到好匹克
如果大家发现新的event, 也请及时跟帖update，非常感谢 :)
Event Thread 不是推荐股票，欢迎讨论。
先给大家总结10月份的，以后每月开一贴哈
====================================
发信人: justsing (飞天的猪), 信区: pennystock
标 题: Re: 【Biotech Event Thread】
发信站: BBS 未名空间站 (Thu Oct 15 22:23:05 2009, 美东)
potentially stock-moving biotech events for October:
Oct. 5-6
JMP Securities Healthcare Focus conference
Oct. 7-8
Cowen & Co. 12 th Annual Therapeutics Conference
Oct. 8
FDA approval decision date for Spectrum Pharmaceuticals'(SPPI Quo... 阅读全帖 |
|
y*****l
发帖数: 5997 | 40 FDA Action Dates and Clinical Trials
http://www.mitbbs.com/clubarticle_t2/pennystock/31231721.html
1季度FDA每日观察, 有图形，新闻链接：
http://finance.yahoo.com/q/cq?s=MNKD,OSIP,ACOR,WCRX,SPPI,PRX,DDSS,CADX,GILD,SHPGY,AMLN,SUPG,APPA,HGSI,SLXP,THOR,APPY,CLDA,SOMX,LLY&d=v2
1月, 2月
MNKD,OSIP,ACOR,WCRX,SPPI,PRX,DDSS,CADX,GILD,SHPGY
http://stockcharts.com/scripts/php/candleglance.php?MNKD,OSIP,ACOR,WCRX,SPPI,PRX,DDSS,CADX,GILD,SHPGY|B|E12,26,9
3月
AMLN,SUPG,APPA,HGSI,SLXP,THOR,APPY,CLDA,SOMX,LLY
http://stockcharts.co... 阅读全帖 |
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y*****l
发帖数: 5997 | 41 来自主题: _pennystock版 - sppi SPPI总算开始动了，今天逆势上涨应该是由于这条消息：
Spectrum Pharma Backs Fusilev, Belinostat, Apaziquone FDA Filings In 2010,
2011, 2012, Respectively
Monday 08/09/2010 4:19 PM ET - Dow Jones News
Trading Higher on Heavy Volume are Shares of Spectrum Pharmaceuticals on 1.
1x Above-Average Volume (SPPI)
Tuesday 08/10/2010 1:58 PM ET - Comtex Smartrend(r)
Related Companies
Symbol Last %Chg
SPPI 4.50 6.64%
As of 4:00 PM ET 8/10/10
Shares of Spectrum Pharmaceuticals (NASDAQ:SPPI) are trading up 4% to $4.39... 阅读全帖 |
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y*****l
发帖数: 5997 | 42 Spectrum Pharmaceuticals Ranked One of the Fastest Growing Companies in
North America on Deloitte's 2010 Technology Fast 500(TM)
Friday 11/12/2010 7:00 AM ET - Businesswire
Related Companies
Symbol Last %Chg
SPPI 4.45 -2.84%
As of 4:00 PM ET 11/30/10
Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI), a biotechnology company with
fully integrated commercial and drug development operations with a primary
focus in oncology, today announced that it ranked #23 on Technology Fast 500
(TM)... 阅读全帖 |
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b*****h
发帖数: 783 | 43 sppi 的FUSILEV 这个季度卖了23M, 几乎是上个季度的4倍（6M). 公司开始赚钱了。这
对一直烧钱生物公司来说是一个turn
around。 |
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b*****h
发帖数: 783 | 44 sppi 的FUSILEV 这个季度卖了23M, 几乎是上个季度的4倍（6M). 公司开始赚钱了。这
对一直烧钱生物公司来说是一个turn
around。 |
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b*****h
发帖数: 783 | 45 adam说的挺对，zevalin 才是sppi的主要产品，可惜他们卖的不理想。Fusilev 很难竞
争过generic。 |
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b*****h
发帖数: 783 | 47 来自主题: _pennystock版 - SPPI trade on rumor is not a good strategy. the sale of its key product ZEVALIN
was not good , and sale of FUSILEV
will drop as the supply of generic back. |
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b*****h
发帖数: 783 | 48 下一个er risk不小，如果Fusilev 卖不好，他们就会扭赢为亏。 |
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