y*****l
发帖数: 5997 | 1 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 regulatory milestones in 2011 based on
expected but not yet completed drug approval filings.
This FDA drug approval calendar updates and expands a similar calendar
published in December.
Pfizer(PFE_) and Protalix Biotherapeutics(PLX_)
Drug/indication: Uplyso for Gaucher's disease
Approval decision date: Feb. 25, 2011
Salix Pharmaceuticals(SLXP_)
Drug/indication: Xifaxan for irritable bowel syndrome
Approval decision date: March 7, 2011
Xiafaxan is already approved for travelers' diarrhea and hepatic
encephalopathy.
Human Genome Sciences(HGSI_)
Drug/indication: Benlysta for lupus
Approval decision date: March 10, 2011
If approved, Benlysta would be the first new drug for lupus patients in 50
years. GlaxoSmithKline(GSK_) will co-market Benlysta. The FDA's approval
decision date was pushed back three months from Dec. 9, 2010.
Bristol-Myers Squibb(BMY_)
Drug/indication: Yervoy (ipilimumab) for melanoma
Approval decision date: March 26, 2011
FDA cancelled and has no plans to reschedule an advisory panel meeting
originally set for Feb. 9. Bristol is seeking initial approval for
ipilimumab for patients who have previously received treatment for melanoma.
Dendreon(DNDN_)
Drug/indication: Provenge for prostate cancer (manufacturing expansion)
Approval decision date: March 2011
Dendreon is seeking FDA approval to expand Provenge manufacturing capacity
at its New Jersey facility. Two additional Provenge plants are under
construction outside Atlanta and in Orange Country, Calif. that are expected
to come on line in the middle of the year.
Cell Therapeutics(CTIC_)
Drug/indication: Pixantrone for aggressive non-Hodgkin's lymphoma
Approval decision date: First quarter 2011
Cell Therapeutics filed an appeal with FDA contesting the agency's April
2010 rejection of pixantrone.
Forest Laboratories(FRX_)
Drug/indication: Daxas for chronic obstructive pulmonary disorder
Approval decision date: First quarter 2011
This is the second FDA review cycle for Daxas.
Optimer Pharmaceuticals
Drug/indication: Fidaxomicin for Clostridium difficile infection
FDA advisory panel date: April 5, 2011
FDA approval decision date: May 30, 2011
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 bone cancer.
Merck(MRK_)
Drug/indication: Boceprevir for Hepatitis C
Approval decision date:May 2011
Merck will not disclose the exact FDA approval decision date, but it's
likely the first two weeks of May. An FDA advisory panel scheduled for April
27-28 is a likely venue for a boceprevir review.
Vertex Pharmaceuticals(VRTX_)
Drug/indication: Telaprevir for Hepatitis C
Approval decision date: May 23, 2011
An FDA advisory panel scheduled for April 27-28 is a likely venue for a
telaprevir review.
King Pharmaceuticals(KG_) and Acura Pharmaceuticals(ACUR_)
Drug/indication: Acurox, an abuse-resistant, immediate-release opioid.
Approval decision date: June 17, 2011
Pain Therapeutics(PTIE_), Durect Corp.(DRRX_) and King Pharmaceuticals(KG)
Drug/indication:: Remoxy, a abuse-resistant opioid for moderate to severe
pain.
Approval decision date: June 23, 2011
Seattle Genetics(SGEN_)
Drug/indication: brentuximab vedotin for Hodgkin's lymphoma
Approval decision date: Third quarter 2011 (estimated, based on the company'
s forecast for a first-quarter 2011 approval filing.)
Transcept Pharmaceuticals(TSPT_)
Drug/indication: Intermezzo for insomnia
Approval decision date: July 14, 2011
This is the second FDA review for Intermezzo following a complete response
letter in October 2009.
NuPathe(PATH_)
Drug/indication: Zelrix, a transdermal patch for migraines.
Approval decision date: Aug. 29, 2011
Adventrx Pharmaceuticals(ANX_)
Drug/indication: ANX-530 (exelbine) for non-small cell lung cancer
Approval decision date: Sept. 1, 2011
ANX-530 is a reformulation of the generic chemotherapy drug vinorelbine. The
FDA issued a refuse-to-file letter for ANX-530 in 2010.
MELA Sciences(MELA_)
Device/indication: MELAFind for diagnosis of melanoma
Approval decision date: Unknown
FDA rejected MELAFind in March 2010 but an FDA advisory panel in November
narrowly recommended the device's approval over the FDA's objection. The FDA
has not said when it will issue another approval decision for MELAFind.
Additional drugs with potential regulatory milestones in 2011:
Onyx Pharmaceuticals(ONXX_)
Drug/indication: carfilzonib for multiple myeloma
Status: FDA approval filing expected mid-2011
Alimera Sciences(ALIM_) and pSivida(PSDV_)
Drug/indication: Iluvien for diabetic macular edema
Status: FDA rejected Iluvien in December; Alimera intends to resubmit for
approval this year based on new, longer-term data.
Genzyme(GENZ_) and Isis Pharmaceuticals(ISIS_)
Drug/indication: mipomersen for severe hypercholesterolemia
Status: Genzyme is in the process of being acquired by Sanofi-Aventis, which
may affect the regulatory timelines for mipomersen. Genzyme had previously
suggested that the mipomersen approval filing could be delayed until the
second half of 2011, from the previous estimate of a filing in the first
half 2011.
MAP Pharmaceuticals(MAPP_)
Drug/indication: Levadex for migraines
Status: MAP intends to file for Levadex approval in the first half of 2011.
Vivus(VVUS_)
Drug/indication: Qnexa for obesity
Status: FDA rejected Qnexa in October. Vivus intends to resubmit Qnexa to
FDA in 2011.
Amylin Pharmaceuticals(AMLN_), Alkermes(ALKS_) and Eli Lilly(LLY_)
Drug/indication: Bydureon for diabetes
Status: Additional clinical work required by FDA after October rejection is
ongoing. Resubmission expected by end of 2011.
Alexza Pharmaceuticals(ALXA_)
Drug/indication: AZ-004 for agitation in patients with schizophrenia or
bipolar disorder
Status: Alexza plans to resubmit AZ-004 to FDA in July 2011. |
X*****s
发帖数: 2767 | |
N***e
发帖数: 263 | |
g**********1
发帖数: 399 | 4 ding~~
genz can be ignored... |
K**********r
发帖数: 2640 | |
K********g
发帖数: 9389 | 6 哈哈哈。明天PLX照样死
【在 K**********r 的大作中提到】
: SLXP今天死掉了吧。
: 明天看PLX的了。。。
|
K**********r
发帖数: 2640 | 7 完蛋了。你这么说，我今天真应该买点。。。
【在 K********g 的大作中提到】
: 哈哈哈。明天PLX照样死
|
K**********r
发帖数: 2640 | 8 哈，silly goose怎么长了个乌鸦嘴？好奇怪啊。。。
【在 K********g 的大作中提到】
: 哈哈哈。明天PLX照样死
|
f**********g
发帖数: 2252 | 9 KevinsFather & biofish,
How much % your think for HGSI? 3x.
【在 K**********r 的大作中提到】
: SLXP今天死掉了吧。
: 明天看PLX的了。。。
|
b*****h
发帖数: 783 | 10 hgsi 过的概率挺大，不过股价已经比较高了，用点call试试运气。呵呵
【在 f**********g 的大作中提到】
: KevinsFather & biofish,
: How much % your think for HGSI? 3x.
|
|
|
f**********g
发帖数: 2252 | 11 How much do u think it worth once approved? 28?
【在 b*****h 的大作中提到】
: hgsi 过的概率挺大，不过股价已经比较高了，用点call试试运气。呵呵
|
K********g
发帖数: 9389 | 12 我靠，28？50年的红斑狼疮药哦，那些鬼毛子最喜欢长这玩意了。
【在 f**********g 的大作中提到】
: How much do u think it worth once approved? 28?
|
K**********r
发帖数: 2640 | 13 怎么说呢，红斑狼疮是个比较复杂的系统疾病。一旦通过，价格肯定不只28。
现在的主要矛盾在于药效和市场需求。一方面这个药效果不是很好，另一方面是市场长
时间没新药，而是使用激素。FDA在手松的时候，一般会从市场来考虑，也就是说，虽
然这个药不是perfect，但是它能满足市场的需要，给患者带来福音，而且相对安全的
话，这个药就可能会批。可这几天看来看去，FDA手咋那么紧啊。。。 |
p****r
发帖数: 4348 | 14 thanks
chronological
a
【在 y*****l 的大作中提到】
: 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 regulatory milestones in 2011 based on
: expected but not yet completed drug approval filings.
: This FDA drug approval calendar updates and expands a similar calendar
|
K********g
发帖数: 9389 | 15 总要先拿几个替死鬼来充数，否则全部批准，岂不是显得FDA太容易过了。
不过PLX肯定不会过，这是肯定的。
HGSI过还是不过，很难说。我觉得过的支持点在于Panel Review的结果。不过的支持点
就很难说了
【在 K**********r 的大作中提到】
: 怎么说呢，红斑狼疮是个比较复杂的系统疾病。一旦通过，价格肯定不只28。
: 现在的主要矛盾在于药效和市场需求。一方面这个药效果不是很好，另一方面是市场长
: 时间没新药，而是使用激素。FDA在手松的时候，一般会从市场来考虑，也就是说，虽
: 然这个药不是perfect，但是它能满足市场的需要，给患者带来福音，而且相对安全的
: 话，这个药就可能会批。可这几天看来看去，FDA手咋那么紧啊。。。
|
h*****8
发帖数: 4754 | 16 我的PLX啊！我几天没看股市，把它给忘了。
谁发几个包子安慰安慰吧!
【在 K**********r 的大作中提到】
: 哈，silly goose怎么长了个乌鸦嘴？好奇怪啊。。。
|
b*****h
发帖数: 783 | 17 我赌30以上，，小赌娱乐。。
【在 K********g 的大作中提到】
: 我靠，28？50年的红斑狼疮药哦，那些鬼毛子最喜欢长这玩意了。
|
y*****l
发帖数: 5997 | 18 不过的话或跌到多少？风险收益大的话就值得一赌了。
【在 K**********r 的大作中提到】
: 怎么说呢，红斑狼疮是个比较复杂的系统疾病。一旦通过，价格肯定不只28。
: 现在的主要矛盾在于药效和市场需求。一方面这个药效果不是很好，另一方面是市场长
: 时间没新药，而是使用激素。FDA在手松的时候，一般会从市场来考虑，也就是说，虽
: 然这个药不是perfect，但是它能满足市场的需要，给患者带来福音，而且相对安全的
: 话，这个药就可能会批。可这几天看来看去，FDA手咋那么紧啊。。。
|
b*****h
发帖数: 783 | 19 杯具下跌空间巨大，，hold股票risk/return很不划算。
【在 y*****l 的大作中提到】
: 不过的话或跌到多少？风险收益大的话就值得一赌了。
|
K********g
发帖数: 9389 | 20 是的。不过肯定腰斩，甚至更多，呵呵。
【在 b*****h 的大作中提到】
: 杯具下跌空间巨大，，hold股票risk/return很不划算。
|
|
|
f**********g
发帖数: 2252 | 21 Lao niu do not buy it, hehe.
【在 K********g 的大作中提到】
: 是的。不过肯定腰斩，甚至更多，呵呵。
|
K**********r
发帖数: 2640 | 22 一旦杯具，这个药很可能连翻盘的机会都没有，因为最核心的因素是药效，你做再多的
临床试验也不可能提高药效。
【在 y*****l 的大作中提到】
: 不过的话或跌到多少？风险收益大的话就值得一赌了。
|
p********e
发帖数: 1960 | 23 Your OVTI makes up the "loss" on PLX....your entry price for PLX around 6
ba?
【在 h*****8 的大作中提到】
: 我的PLX啊！我几天没看股市，把它给忘了。
: 谁发几个包子安慰安慰吧!
|
h*****8
发帖数: 4754 | 24 NND，前几天把OVTI的股票到地方都被割了，就留了点CALL。
这下亏大发了！！！
【在 p********e 的大作中提到】
: Your OVTI makes up the "loss" on PLX....your entry price for PLX around 6
: ba?
|
p********e
发帖数: 1960 | 25 转帐完成
转给用户:hill168,现金(伪币):16.88,收取手续费:0.17
【在 h*****8 的大作中提到】
: NND，前几天把OVTI的股票到地方都被割了，就留了点CALL。
: 这下亏大发了！！！
|
h*****8
发帖数: 4754 | 26 谢谢，我的PLX倒是6.6买的，上次10.X卖了一半，剩下的能反弹到7.0x就卖了算了。
【在 p********e 的大作中提到】
: 转帐完成
: 转给用户:hill168,现金(伪币):16.88,收取手续费:0.17
|
b*****h
发帖数: 783 | 27 成本很低呵，
【在 h*****8 的大作中提到】
: 谢谢，我的PLX倒是6.6买的，上次10.X卖了一半，剩下的能反弹到7.0x就卖了算了。
|
h*****8
发帖数: 4754 | 28 呵呵，买的很早了。
刚才7.07卖了
好在两只部队都没亏。
MOVE ON了。
【在 b*****h 的大作中提到】
: 成本很低呵，
|
X*****s
发帖数: 2767 | 29 应该能过吧，该公司的ceo在1月份24块多进了6万股，总价1百多万，要是他没底，会这
么砸钱进去？
【在 b*****h 的大作中提到】
: hgsi 过的概率挺大，不过股价已经比较高了，用点call试试运气。呵呵
|
f**********g
发帖数: 2252 | 30 Cong HGSI!
BMY is next.
【在 b*****h 的大作中提到】
: hgsi 过的概率挺大，不过股价已经比较高了，用点call试试运气。呵呵
|
|
|
y*****l
发帖数: 5997 | 31 http://www.thestreet.com/story/11131722/1/biotech-calendar-2011
Biotech Calendar: 2011 FDA Drug Approvals
By Adam Feuerstein 05/25/11
BOSTON (TheStreet) -- The 2011 FDA drug approval calendar has been updated.
For easier reference, this regulatory calendar is organized in chronological order based on the drug approval decision date. Information on pending FDA advisory panels is also included.
Optimer Pharmaceuticals(OPTR_)
Drug/indication: Dificid for Clostridium difficile infection
FDA approval decision date: May 30, 2011
GlaxoSmithKline(GSK_) and Valeant Pharmaceuticals(VRX_)
Drug/indication: Potiga for partial seizures due to epilepsy
FDA approval decision date: June 14, 2011
Glaxo and Valeant submitted on April 15 a response to the FDA's complete response letter for Potiga which was delivered on Nov 30, 2010.
Bristol-Myers Squibb(BMY_)
Drug/indication: belatacept for kidney transplant rejection
FDA approval decision date: June 15, 2011
FDA initially rejected belatacept in May 2010.
Pfizer(PFE_) and Acura Pharmaceuticals(ACUR_)
Drug/indication: Acurox, an abuse-resistant, immediate-release opioid. Approval decision date: June 17, 2011
Regeneron Pharmaceuticals(REGN_)
Drug/indication: VEGF Trap-Eye for wet age-related macular degeneration
FDA advisory meeting: June 17, 2011
Approval decision date: Aug. 20, 2011
Salix Pharmaceuticals(SLXP_)
Drug/indication: Xifaxan for irritable bowel syndrome (IBS)
FDA meeting: June 20, 2011
Xiafaxan is already approved for travelers' diarrhea and hepatic encephalopathy but FDA rejected the drug for IBS in March, requesting additional retreatment data. Salix is expected to update investors on the timeline for Xifaxan's IBS resubmission following the June 20 meeting with FDA.
Fibrocell Science(FCSC.OB)
Drug/indication: laViv for treatment for nasolabial folds and wrinkles
Approval decision date: June 22, 2011
Pain Therapeutics(PTIE_), Durect Corp.(DRRX_) and Pfizer(PFE)
Drug/indication:: Remoxy, an abuse-resistant opioid for moderate to severe pain.
Approval decision date: June 23, 2011
Dendreon(DNDN)
Drug/indication: Provenge for prostate cancer (Orange County, Calif. manufacturing expansion)
Approval decision date: June 30, 2011
Dendreon is seeking FDA approval to expand Provenge's manufacturing capacity to a new facility in Southern California. A second, new manufacturing plant in Atlanta is also under construction, expected to receive FDA approval in late August or early September.
Cell Therapeutics(CTIC)
Drug/indication: Pixantrone for aggressive non-Hodgkin's lymphoma
Approval decision date: June 2011
Cell Therapeutics filed an appeal with FDA contesting the agency's April 2010 rejection of pixantrone.
Transcept Pharmaceuticals(TSPT)
Drug/indication: Intermezzo for insomnia
Approval decision date: July 14, 2011
This is the second FDA review for Intermezzo following a complete response letter in October 2009.
AstraZeneca(AZN)
Drug/indication: Brilinta, a blood thinner used in patients with acute coronary syndrome.
Approval decision date: July 20, 2011
FDA rejected Brilinta in December 2010.
Gilead Sciences(GILD)
Drug/indication: Btripla for HIV
Approval decision date: Aug. 10, 2011
Btripla is a single-pill treatment for HIV that combines Gilead's Truvada with Johnson & Johnson's rilpivirine.
NuPathe(PATH)
Drug/indication: Zelrix, a transdermal patch for migraines.
Approval decision date: Aug. 29, 2011
Seattle Genetics(SGEN)
Drug/indication: Adcetris for Hodgkin's lymphoma and anaplastic large cell lymphoma (ALCL)
Approval decision date: Aug. 30, 2011
Adventrx Pharmaceuticals(ANX)
Drug/indication: ANX-530 (exelbine) for non-small cell lung cancer
Approval decision date: Sept. 1, 2011
ANX-530 is a reformulation of the generic chemotherapy drug vinorelbine. The FDA issued a refuse-to-file letter for ANX-530 in 2010.
Corcept Therapeutics(CORT)
Drug/indication: Corlux for Cushing's Syndrome
Approval decision date: Oct. 15, 2011 (tentative, based on April 15 FDA filing date and request for a six-month priority review.)
Bristol-Myers Squibb and AstraZeneca
Drug/indication: dapagliflozin for diabetes
Approval decision date: Oct. 28, 2011
An FDA advisory panel may be convened on July 19 to review dapagliflozin.
Alimera Sciences(ALIM) and pSivida(PSDV)
Drug/indication: Iluvien for diabetic
Approval decision date: Nov. 13, 2011 (tentative, based on May 13 resubmission and expected six-month FDA review.)
Teva Pharmaceuticals(TEVA) and BioSante Pharmaceuticals(BPAX)
Drug/indication: Bio-T-Gel for male low testosterone levels
Approval decision date: Nov. 14, 2011
Spectrum Pharmaceuticals(SPPI)
Drug/indication: Zevalin for non-Hodgkin's lymphoma (removal of Bioscan requirement)
Approval decision date: Nov. 20, 2011
Antares Pharma(AIS)
Drug/indication: Anturol for overactive bladder
Approval decision date: Dec. 8, 2011
Pfizer
Drug/indication: crizotinib for non-small cell lung cancer
Approval decision date: Before end of 2011
Sources: BioMedTracker.com, TheStreet research and company reports.
--Written by Adam Feuerstein in Boston.
************************************************************************
发信人: KeepBuying (雁过留声), 信区: pennystock
标 题: 癌症药股列表
发信站: BBS 未名空间站 (Sun Apr 10 01:56:44 2011, 美东)
新鲜出炉，没有列出超大药股，都属于中小药股，有癌症药在Pipeline中的。四颗星属
于有PII或者PIII的研发，基本面也很好，3颗星还不错，最近有PII或者PIII的研发，
基本面过得去，2颗星有癌症药研发，基本面一般，1星的有癌症药的研发，但是公司的
FA不好。
也许有不对的地方，欢迎补充。大家也要相当小心，药股风险很大，大跌了捂几年都不
一定能回来，有的干脆就可能破产。所以要想当小心，买一点点玩可以，切忌不要投机
哦。大家亏钱了，不要怪我哦，我这里已经说了风险很大。赚钱了也恭喜你。
AEZS **
ALNY ***
ALTH ***
ANX *
ARAY (Not drug)
ARIA ****
ARQL ***
ARRY ***
AVEO ****
AVII *
BCRX *
CBLI **
CLDA *
CRIS ***
CYCC *
CYTK ***
CYTR **
DCTH ***
DNDN ****
ENDP **
ENZN ***
EXEL ****
GERN ***
GHDX **
HGSI ****
IMGN ****
IMMU ***
INCY ****
INFI ***
INO **
ISIS ****
KERX ****
LGND ***
MDVN ***
MITI ****
MYRX *
ONTY ***
ONXX ****
PCYC **
PGNX **
PPHM ***
REGN ****
RIGL ***
SCLN **
SGEN ****
SNTA ***
SPPI ***
SUPG **
THLD *
UTHR ***
VICL ***
************************************************************************
四星级(有PII或者PIII的研发，基本面也很好)：
http://finviz.com/screener.ashx?v=351&t=ARIA,AVEO,DNDN,EXEL,HGS
三星级(最近有PII或者PIII的研发，基本面过得去)：
http://finviz.com/screener.ashx?v=351&t=ALNY,ALTH,ARQL,ARRY,CRI
************************************************************************
发信人: KeepBuying (雁过留声), 信区: pennystock
标 题: Re: NND, 不该涨的都涨了, 该涨的不涨
发信站: BBS 未名空间站 (Fri Jul 8 00:31:03 2011, 美东)
首先，要做某个药股，要对该药股的基本面做扎实了。药到底如何，这当然也是主要看
数据，看分析了。但是比如Adam的分析还是参考一下，那还是很能到位的。
第二，药股和药有绝对重要的联系。否则死都不知道怎么死的。
第三，做药股不外乎就是做FDA审批,做重要的Trial的消息，这些都和基本面密切相关。
再说说你的几个观点，PATH为何会到9-11，你的基本依据是那些？
DCTH的结果非常Positive，是肝癌患者治疗的非常好的物理手段，你怎么就是Negative
?Adam都认为Positive，他只是觉得市场不够大而已。我也基本同意Adam的观点。算上
美国和欧洲市场，市场估计能达到200-300M，那么股价应该在10块以上。Adam根据美国
市场的估计是7块以上。DCTH只是因为需要补充规范的安全数据，所以被FDA推迟了而已。
另外ALMN的糖尿病药，明年估计有料，明年上20问题不是太大。BPAX，这个药，市场很
大，但是伟哥的专利期快过了，市场会受Generic的药冲击，不过今年年底必然有戏。
估计涨到5-6块问题也不大，就看各位的耐心了。
KERX,其实这个药去年的数据比ARIA还热度，我觉得三期数据出来后，如果好的话，就
会冲天。现在还不好说，但是是目前为数不多低价有前景的癌症药股了。其他好的有前
景的全他妈的飞了。
另外，药股的炒作，有几个热点也值得注意：癌症药，糖尿病，肝炎，心脏和心血管病
，艾滋病，帕金森等神经疑难杂症病药等等。
不是随便个药就可以玩的，比如那些镇痛药，就烂大街了，没啥意思。 |
X*****s
发帖数: 2767 | |
N***e
发帖数: 263 | |
g**********1
发帖数: 399 | 34 ding~~
genz can be ignored... |
K**********r
发帖数: 2640 | 35 SLXP今天死掉了吧。
明天看PLX的了。。。 |
K********g
发帖数: 9389 | 36 哈哈哈。明天PLX照样死
【在 K**********r 的大作中提到】
: SLXP今天死掉了吧。
: 明天看PLX的了。。。
|
K**********r
发帖数: 2640 | 37 完蛋了。你这么说，我今天真应该买点。。。
【在 K********g 的大作中提到】
: 哈哈哈。明天PLX照样死
|
K**********r
发帖数: 2640 | 38 哈，silly goose怎么长了个乌鸦嘴？好奇怪啊。。。
【在 K********g 的大作中提到】
: 哈哈哈。明天PLX照样死
|
f**********g
发帖数: 2252 | 39 KevinsFather & biofish,
How much % your think for HGSI? 3x.
【在 K**********r 的大作中提到】
: SLXP今天死掉了吧。
: 明天看PLX的了。。。
|
b*****h
发帖数: 783 | 40 hgsi 过的概率挺大，不过股价已经比较高了，用点call试试运气。呵呵
【在 f**********g 的大作中提到】
: KevinsFather & biofish,
: How much % your think for HGSI? 3x.
|
|
|
f**********g
发帖数: 2252 | 41 How much do u think it worth once approved? 28?
【在 b*****h 的大作中提到】
: hgsi 过的概率挺大，不过股价已经比较高了，用点call试试运气。呵呵
|
K********g
发帖数: 9389 | 42 我靠，28？50年的红斑狼疮药哦，那些鬼毛子最喜欢长这玩意了。
【在 f**********g 的大作中提到】
: How much do u think it worth once approved? 28?
|
K**********r
发帖数: 2640 | 43 怎么说呢，红斑狼疮是个比较复杂的系统疾病。一旦通过，价格肯定不只28。
现在的主要矛盾在于药效和市场需求。一方面这个药效果不是很好，另一方面是市场长
时间没新药，而是使用激素。FDA在手松的时候，一般会从市场来考虑，也就是说，虽
然这个药不是perfect，但是它能满足市场的需要，给患者带来福音，而且相对安全的
话，这个药就可能会批。可这几天看来看去，FDA手咋那么紧啊。。。 |
p****r
发帖数: 4348 | 44 thanks
chronological
a
【在 y*****l 的大作中提到】
: http://www.thestreet.com/story/11131722/1/biotech-calendar-2011
: Biotech Calendar: 2011 FDA Drug Approvals
: By Adam Feuerstein 05/25/11
: BOSTON (TheStreet) -- The 2011 FDA drug approval calendar has been updated.
: For easier reference, this regulatory calendar is organized in chronological order based on the drug approval decision date. Information on pending FDA advisory panels is also included.
: Optimer Pharmaceuticals(OPTR_)
: Drug/indication: Dificid for Clostridium difficile infection
: FDA approval decision date: May 30, 2011
: GlaxoSmithKline(GSK_) and Valeant Pharmaceuticals(VRX_)
: Drug/indication: Potiga for partial seizures due to epilepsy
|
K********g
发帖数: 9389 | 45 总要先拿几个替死鬼来充数，否则全部批准，岂不是显得FDA太容易过了。
不过PLX肯定不会过，这是肯定的。
HGSI过还是不过，很难说。我觉得过的支持点在于Panel Review的结果。不过的支持点
就很难说了
【在 K**********r 的大作中提到】
: 怎么说呢，红斑狼疮是个比较复杂的系统疾病。一旦通过，价格肯定不只28。
: 现在的主要矛盾在于药效和市场需求。一方面这个药效果不是很好，另一方面是市场长
: 时间没新药，而是使用激素。FDA在手松的时候，一般会从市场来考虑，也就是说，虽
: 然这个药不是perfect，但是它能满足市场的需要，给患者带来福音，而且相对安全的
: 话，这个药就可能会批。可这几天看来看去，FDA手咋那么紧啊。。。
|
h*****8
发帖数: 4754 | 46 我的PLX啊！我几天没看股市，把它给忘了。
谁发几个包子安慰安慰吧!
【在 K**********r 的大作中提到】
: 哈，silly goose怎么长了个乌鸦嘴？好奇怪啊。。。
|
b*****h
发帖数: 783 | 47 我赌30以上，，小赌娱乐。。
【在 K********g 的大作中提到】
: 我靠，28？50年的红斑狼疮药哦，那些鬼毛子最喜欢长这玩意了。
|
y*****l
发帖数: 5997 | 48 不过的话或跌到多少？风险收益大的话就值得一赌了。
【在 K**********r 的大作中提到】
: 怎么说呢，红斑狼疮是个比较复杂的系统疾病。一旦通过，价格肯定不只28。
: 现在的主要矛盾在于药效和市场需求。一方面这个药效果不是很好，另一方面是市场长
: 时间没新药，而是使用激素。FDA在手松的时候，一般会从市场来考虑，也就是说，虽
: 然这个药不是perfect，但是它能满足市场的需要，给患者带来福音，而且相对安全的
: 话，这个药就可能会批。可这几天看来看去，FDA手咋那么紧啊。。。
|
b*****h
发帖数: 783 | 49 杯具下跌空间巨大，，hold股票risk/return很不划算。
【在 y*****l 的大作中提到】
: 不过的话或跌到多少？风险收益大的话就值得一赌了。
|
K********g
发帖数: 9389 | 50 是的。不过肯定腰斩，甚至更多，呵呵。
【在 b*****h 的大作中提到】
: 杯具下跌空间巨大，，hold股票risk/return很不划算。
|
|
|
f**********g
发帖数: 2252 | 51 Lao niu do not buy it, hehe.
【在 K********g 的大作中提到】
: 是的。不过肯定腰斩，甚至更多，呵呵。
|
K**********r
发帖数: 2640 | 52 一旦杯具，这个药很可能连翻盘的机会都没有，因为最核心的因素是药效，你做再多的
临床试验也不可能提高药效。
【在 y*****l 的大作中提到】
: 不过的话或跌到多少？风险收益大的话就值得一赌了。
|
p********e
发帖数: 1960 | 53 Your OVTI makes up the "loss" on PLX....your entry price for PLX around 6
ba?
【在 h*****8 的大作中提到】
: 我的PLX啊！我几天没看股市，把它给忘了。
: 谁发几个包子安慰安慰吧!
|
h*****8
发帖数: 4754 | 54 NND，前几天把OVTI的股票到地方都被割了，就留了点CALL。
这下亏大发了！！！
【在 p********e 的大作中提到】
: Your OVTI makes up the "loss" on PLX....your entry price for PLX around 6
: ba?
|
p********e
发帖数: 1960 | 55 转帐完成
转给用户:hill168,现金(伪币):16.88,收取手续费:0.17
【在 h*****8 的大作中提到】
: NND，前几天把OVTI的股票到地方都被割了，就留了点CALL。
: 这下亏大发了！！！
|
h*****8
发帖数: 4754 | 56 谢谢，我的PLX倒是6.6买的，上次10.X卖了一半，剩下的能反弹到7.0x就卖了算了。
【在 p********e 的大作中提到】
: 转帐完成
: 转给用户:hill168,现金(伪币):16.88,收取手续费:0.17
|
b*****h
发帖数: 783 | 57 成本很低呵，
【在 h*****8 的大作中提到】
: 谢谢，我的PLX倒是6.6买的，上次10.X卖了一半，剩下的能反弹到7.0x就卖了算了。
|
h*****8
发帖数: 4754 | 58 呵呵，买的很早了。
刚才7.07卖了
好在两只部队都没亏。
MOVE ON了。
【在 b*****h 的大作中提到】
: 成本很低呵，
|
X*****s
发帖数: 2767 | 59 应该能过吧，该公司的ceo在1月份24块多进了6万股，总价1百多万，要是他没底，会这
么砸钱进去？
【在 b*****h 的大作中提到】
: hgsi 过的概率挺大，不过股价已经比较高了，用点call试试运气。呵呵
|
f**********g
发帖数: 2252 | 60 Cong HGSI!
BMY is next.
【在 b*****h 的大作中提到】
: hgsi 过的概率挺大，不过股价已经比较高了，用点call试试运气。呵呵
|
|
|
y*****l
发帖数: 5997 | 61 http://www.rttnews.com/CorpInfo/FDACalendar.aspx?Node=B8
Date Company Name Ticker Drug Event Outcome Details
08/20/2011 Regeneron Pharmaceuticals REGN VEGF Trap-Eye (BLA)
FDA decision on VEGF Trap-Eye for neovascular form of age-related macular
degeneration (wet AMD).
-News
08/10/2011 Gilead Sciences Inc. GILD Truvada/TMC278 (refiled NDA)
FDA decision on Truvada/TMC278 for HIV-1 infection in adults
-Drug Status
07/28/2011 Pacira Pharmaceuticals, Inc. PCRX Exparel (NDA) FDA
decision on Exparel for postsurgical pain management
-Market Potential
07/20/2011 AstraZeneca PLC AZN, AZN.L Brilinta (NDA class II
resubmission) FDA decision on Brilinta for treatment of acute coronary
syndrome (ACS
-Rival Drugs
-Market Potential
-Approved in Other Countries
07/14/2011 Transcept Pharmaceuticals, Inc. TSPT Intermezzo (NDA
resubmission) FDA decision on Intermezzo as a sleep aid for use in the
middle of the night at the time a patient awakens and has difficulty
returning to sleep
-News
06/23/2011 DURECT CORP DRRX REMOXY (NDA resubmission) FDA
decision on REMOXY for moderate-to-severe chronic pain
-News
06/23/2011 Pfizer Inc. PFE REMOXY (NDA resubmission) FDA
decision on REMOXY for moderate-to-severe chronic pain
-Drug Status
-News
06/23/2011 Pain Therapeutics Inc PTIE REMOXY (NDA resubmission)
FDA decision on REMOXY for moderate-to-severe chronic pain
-News
06/22/2011 Fibrocell Science, Inc. FCSC.OB LaViv (BLA Complete
Response Resubmission) FDA decision on LaViv for the treatment of
moderate to severe nasolabial folds and wrinkles
06/20/2011 Johnson & Johnson JNJ Abiraterone (Zytiga) (NDA) FDA
decision on Zytiga for treatment of castrate resistant prostate cancer
FDA approved Zytiga for treatment of castrate resistant prostate cancer on
April 28, 2 months ahead of schedule
-Rival Drugs
-Market Potential
06/17/2011 Acura Pharmaceuticals Inc ACUR ACUROX (oxycodone HCl)
Tablets (NDA) FDA decision on ACUROX for the relief of moderate to severe
pain
-Drug Status
-Rival Drugs
06/17/2011 Regeneron Pharmaceuticals REGN VEGF Trap-Eye (BLA)
FDA panel to review VEGF Trap-Eye for neovascular form of age-related
macular degeneration
-Drug Status
05/30/2011 OPTIMER PHARMACEUTIC OPTR Fidaxomicin (NDA) FDA
decision on Fidaxomicin for the treatment of Clostridium difficile infection
-Drug Status
-News
05/23/2011 Vertex Pharmaceuticals Inc. VRTX Telaprevir (NDA)
FDA decision on Telaprevir for hepatitis C FDA approved Telaprevir (
Incivek) for hepatitis C
-Market Potential
-Approved in Other Countries
-News
05/16/2011 Merck & Co Inc. MRK Boceprevir (under the trade name
VICTRELIS) (NDA) FDA decision on Boceprevir (VICTRELIS) for hepatitis C
(mid-May decision date) FDA approved Boceprevir (VICTRELIS) for hepatitis
C on May 13
-Approved in Other Countries
-News |
y*****l
发帖数: 5997 | 62 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 combination chemotherapy in advanced
metastatic colorectal cancer. FDA approved Fusilev for expanded use in
colorectal cancer on Apr.29
-Approved in Other Countries
-News
04/28/2011 Vertex Pharmaceuticals Inc. VRTX Telaprevir (NDA) FDA
panel review of Telaprevir for chronic hepatitis C genotype 1 infection
FDA panel unanimously recommended approval of Telaprevir for chronic
hepatitis C
-News
04/27/2011 Merck & Co Inc. MRK Boceprevir (under the trade name
VICTRELIS) (NDA) FDA Committee to review Boceprevir (VICTRELIS) as
treatment for chronic HCV genotype 1 infection FDA panel unanimously
recommended VICTRELIS for treatment of chronic HCV genotype 1 infection
-Drug Status
-Approved in Other Countries
-News
04/13/2011 KV Pharmaceutical Co. KVA, KVb Makena (formerly known as
Gestiva) (NDA) FDA decision on Makena to prevent preterm births FDA
approved Makena ( formerly referred to as Gestiva) on Feb.4
-Rival Drugs
-News
04/12/2011 Novartis AG NVS Afinitor (sNDA) FDA panel review of
Afinitor for treatment of advanced neuroendocrine tumors of gastrointestinal
, lung, or pancreatic origin; Amended the submission to only seek approval
for advanced neuroendocrine tumors of pancreatic origin on April 8 FDA
panel voted unanimously recommending addnl. approval of Afinitor for
advanced neuroendocrine tumors originating in pancreas.
-Drug Status
-News
04/12/2011 Pfizer Inc. PFE Sutent (sNDA) FDA panel to review
Sutent for proposed addnl indication in treating unresectable pancreatic
neuroendocrine tumors (PNET). FDA Panel voted 8-2 recommending approval
of Sutent for proposed addnl indication in treating unresectable pancreatic
neuroendocrine tumors (PNET).
-Drug Status
-News
04/06/2011 XENOPORT INC XNPT Horizant -ER (Amended NDA) FDA
decision on Horizant-ER for treatment of moderate-to-severe primary Restless
Legs Syndrome FDA approves Horizant-ER for treatment of moderate-to-
severe primary Restless Legs Syndrome
-Rival Drugs
-News
04/05/2011 OPTIMER PHARMACEUTIC OPTR DIFICID (fidaxomicin) (NDA)
FDA panel to review DIFICID for the treatment of Clostridium difficile
infection FDA panel voted unanimously to recommend approval of Dificid
for Treatment of Clostridium difficile infection
-Drug Status
-News
04/01/2011 Novartis AG NVS Arcapta Neohaler or QAB149 (NDA) FDA
decision on Arcapta Neohaler (QAB149) for Chronic Obstructive Pulmonary
Disease FDA extends decision date by three months to July 2011
-News
03/26/2011 Bristol-Myers Squibb Co. BMY Ipilimumab or Yervoy (BLA)
FDA decision on Ipilimumab (Yervoy) for treatment of advanced melanoma
FDA approved Ipilimumab (Yervoy) for treatment of advanced melanoma
-Rival Drugs
-Market Potential
-News
03/14/2011 Bayer AG BYR.L, BAYRY.PK, BAYZF.PK Gadobutrol injection
(NDA) FDA decision on Gadobutrol (Gadavist) for use in diagnostic
magnetic resonance imaging FDA approved Gadavist (gadobutrol) Injection
for magnetic resonance imaging of the Central Nervous System on March 14
-Drug Status
03/10/2011 GlaxoSmithKline PLC GSK, GSK.L Lamictal-XR (sNDA) FDA
panel to review Lamictal-XR for additional approval as monotherapy in
patients 13 and older with partial seizures already on a single
antiepileptic drug. FDA panel recommended additional approval of
Lamictal-XR as monotherapy for treatment of partial seizures on March 10
-Approved in Other Countries
03/10/2011 Human Genome Sciences Inc HGSI Benlysta (NDA) FDA
decision on Benlysta as a potential lupus treatment FDA Approves Benlysta
for treating lupus
-Drug Status
-Rival Drugs
-Market Potential
-News
03/08/2011 Novartis AG NVS Arcapta Neohaler (NDA) FDA panel to
review Arcapta Neohaler for Chronic Obstructive Pulmonary Disease FDA
panel recommends approval of Arcapta Neohaler for Chronic Obstructive
Pulmonary Disease |
y*****l
发帖数: 5997 | 63 Date Company Name Ticker Drug Event Outcome Details
03/07/2011 Salix Pharmaceuticals Ltd SLXP Xifaxan 550 mg (sNDA)
FDA decision on Xifaxan 550 mg Tablets for the treatment of non-constipation
irritable bowel syndrome and IBS-related bloating. Salix received
Complete Response Letter for Xifaxan supplemental New Drug Application on
March 7th
-Approved in Other Countries
-News
03/01/2011 Forest Laboratories Inc FRX Daliresp (known as Daxas in
other countries) amended NDA FDA decision on Daliresp as treatment for
chronic obstructive pulmonary disease FDA approved Daliresp for chronic
obstructive pulmonary disease on March 1
-Rival Drugs
-Market Potential
-News
02/28/2011 Merck KGaA MKGAY.PK Cladribine Tablets (NDA) FDA
decision on Cladribine as a therapy for relapsing forms of multiple
sclerosis FDA issued complete response letter for Cladribine on March 2
-Market Potential
-Approved in Other Countries
-News
02/25/2011 PROTALIX BIOTHERAPEUTICS PLX Taliglucerase Alfa (NDA)
FDA decision on Taliglucerase Alfa for treatment of Gaucher disease FDA
issues complete response letter for Taliglucerase Alfa
-Drug Status
-Rival Drugs
-News |
y*****l
发帖数: 5997 | 64 http://www.thestreet.com/story/11131722/1/biotech-calendar-2011
Stock quotes in this article:SPPI, CTIC, TSPT, SGEN, ANX, PATH, OPTR
http://finviz.com/screener.ashx?v=341&t=SPPI,CTICD,TSPT,SGEN,AN
Biotech Calendar: 2011 FDA Drug Approvals
By Adam Feuerstein 05/25/11
BOSTON (TheStreet) -- The 2011 FDA drug approval calendar has been updated.
For easier reference, this regulatory calendar is organized in chronological
order based on the drug approval decision date. Information on pending FDA
advisory panels is also included.
Optimer Pharmaceuticals(OPTR_)
Drug/indication: Dificid for Clostridium difficile infection
FDA approval decision date: May 30, 2011
GlaxoSmithKline(GSK_) and Valeant Pharmaceuticals(VRX_)
Drug/indication: Potiga for partial seizures due to epilepsy
FDA approval decision date: June 14, 2011
Glaxo and Valeant submitted on April 15 a response to the FDA's complete
response letter for Potiga which was delivered on Nov 30, 2010.
Bristol-Myers Squibb(BMY_)
Drug/indication: belatacept for kidney transplant rejection
FDA approval decision date: June 15, 2011
FDA initially rejected belatacept in May 2010.
Pfizer(PFE_) and Acura Pharmaceuticals(ACUR_)
Drug/indication: Acurox, an abuse-resistant, immediate-release opioid.
Approval decision date: June 17, 2011
Regeneron Pharmaceuticals(REGN_)
Drug/indication: VEGF Trap-Eye for wet age-related macular degeneration
FDA advisory meeting: June 17, 2011
Approval decision date: Aug. 20, 2011
Salix Pharmaceuticals(SLXP_)
Drug/indication: Xifaxan for irritable bowel syndrome (IBS)
FDA meeting: June 20, 2011
Xiafaxan is already approved for travelers' diarrhea and hepatic
encephalopathy but FDA rejected the drug for IBS in March, requesting
additional retreatment data. Salix is expected to update investors on the
timeline for Xifaxan's IBS resubmission following the June 20 meeting with
FDA.
Fibrocell Science(FCSC.OB)
Drug/indication: laViv for treatment for nasolabial folds and wrinkles
Approval decision date: June 22, 2011
Pain Therapeutics(PTIE_), Durect Corp.(DRRX_) and Pfizer(PFE)
Drug/indication:: Remoxy, an abuse-resistant opioid for moderate to severe
pain.
Approval decision date: June 23, 2011
Dendreon(DNDN)
Drug/indication: Provenge for prostate cancer (Orange County, Calif.
manufacturing expansion)
Approval decision date: June 30, 2011
Dendreon is seeking FDA approval to expand Provenge's manufacturing capacity
to a new facility in Southern California. A second, new manufacturing plant
in Atlanta is also under construction, expected to receive FDA approval in
late August or early September.
Cell Therapeutics(CTIC)
Drug/indication: Pixantrone for aggressive non-Hodgkin's lymphoma
Approval decision date: June 2011
Cell Therapeutics filed an appeal with FDA contesting the agency's April
2010 rejection of pixantrone.
Transcept Pharmaceuticals(TSPT)
Drug/indication: Intermezzo for insomnia
Approval decision date: July 14, 2011
This is the second FDA review for Intermezzo following a complete response
letter in October 2009.
AstraZeneca(AZN)
Drug/indication: Brilinta, a blood thinner used in patients with acute
coronary syndrome.
Approval decision date: July 20, 2011
FDA rejected Brilinta in December 2010.
Gilead Sciences(GILD)
Drug/indication: Btripla for HIV
Approval decision date: Aug. 10, 2011
Btripla is a single-pill treatment for HIV that combines Gilead's Truvada
with Johnson & Johnson's rilpivirine.
NuPathe(PATH)
Drug/indication: Zelrix, a transdermal patch for migraines.
Approval decision date: Aug. 29, 2011
Seattle Genetics(SGEN)
Drug/indication: Adcetris for Hodgkin's lymphoma and anaplastic large cell
lymphoma (ALCL)
Approval decision date: Aug. 30, 2011
Adventrx Pharmaceuticals(ANX)
Drug/indication: ANX-530 (exelbine) for non-small cell lung cancer
Approval decision date: Sept. 1, 2011
ANX-530 is a reformulation of the generic chemotherapy drug vinorelbine. The
FDA issued a refuse-to-file letter for ANX-530 in 2010.
Corcept Therapeutics(CORT)
Drug/indication: Corlux for Cushing's Syndrome
Approval decision date: Oct. 15, 2011 (tentative, based on April 15 FDA
filing date and request for a six-month priority review.)
Bristol-Myers Squibb and AstraZeneca
Drug/indication: dapagliflozin for diabetes
Approval decision date: Oct. 28, 2011
An FDA advisory panel may be convened on July 19 to review dapagliflozin.
Alimera Sciences(ALIM) and pSivida(PSDV)
Drug/indication: Iluvien for diabetic
Approval decision date: Nov. 13, 2011 (tentative, based on May 13
resubmission and expected six-month FDA review.)
Teva Pharmaceuticals(TEVA) and BioSante Pharmaceuticals(BPAX)
Drug/indication: Bio-T-Gel for male low testosterone levels
Approval decision date: Nov. 14, 2011
Spectrum Pharmaceuticals(SPPI)
Drug/indication: Zevalin for non-Hodgkin's lymphoma (removal of Bioscan
requirement)
Approval decision date: Nov. 20, 2011
Antares Pharma(AIS)
Drug/indication: Anturol for overactive bladder
Approval decision date: Dec. 8, 2011
Pfizer
Drug/indication: crizotinib for non-small cell lung cancer
Approval decision date: Before end of 2011
Sources: BioMedTracker.com, TheStreet research and company reports.
--Written by Adam Feuerstein in Boston. |
