y*****l
发帖数: 5997 | 1 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 Pharmac... 阅读全帖 |
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g****e
发帖数: 1426 | 2 Current price: $2.68
Catalyst event: Pfizer earning call at 10:00AM ET on 01/29/2013
PTIE has a partnership with Pfizer on Remoxy, FDA issued a complete response
letter on 6/23/11, and Pfizer is working to understand and
address the issues raised in the letter. Once Pfizer provides any updates on
Remoxy re-submission in later 1st Half of 2013, PTIE will fly.
1. PTIE has over 90m in cash
2. Remoxy will have huge market potential.Remoxy will competes with
Oxycontin, which generated over $3bn of an... 阅读全帖 |
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B*D
发帖数: 481 | 3 说说为什么会涨？
是不是这个原因:
Acura Pharma rises as Pfizer's Remoxy is delayed
Associated Press, 06.24.11, 01:58 PM EDT
NEW YORK -- Shares of Acura Pharmaceuticals Inc. climbed Friday after
regulators delayed approval of a potential competitor to its pain drug
Oxecta.
THE SPARK: Pfizer Inc. ( PFE - news - people ) said the Food and Drug
Administration has asked for more information on its drug candidate Remoxy.
The drug won't be approved until Pfizer can respond to the FDA's concerns
and the agency can revi... 阅读全帖 |
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w****a
发帖数: 12 | 4 Biotech Calendar: 2011 FDA Drug Approvals
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_... 阅读全帖 |
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g****e
发帖数: 1426 | 5 Yes, it is why we need catalyst event to drive the public attention. The
current share price looks to me have no value priced in Remoxy. |
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y*****l
发帖数: 5997 | 6 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 |
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y*****l
发帖数: 5997 | 7 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... 阅读全帖 |
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y*****l
发帖数: 5997 | 8 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
advis... 阅读全帖 |
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b*****h
发帖数: 783 | 9 原来你是这一行业的呵。。
不过外面的预计是peak sale 100m。 而acur的药的确没啥特色，被批准是顺应了fda对
止痛药要求tamper resistant.
加上PTIE/king/pfe 的REMOXY也马上也要出结果了，属于同一类型的药物。所以，搞定
1／10的市场是个wishful thinking. |
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J********e
发帖数: 341 | 10 你觉得Remoxy会过吗?
我觉得会过,但是不知道为什么最近PTIE的put交易的比call多? |
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t**u
发帖数: 1572 | 11 明天出结果? Pain Therapeutics, Inc. announced that the U.S. Food and Drug
Administration (FDA) has accepted a New Drug Application (NDA) resubmission
for REMOXY(R) (controlled-release oxycodone) and has classified it as a
Class 2 resubmission. With the Class 2 designation, the FDA has set a
corresponding Prescription Drug User Fee Act (PDUFA) goal date of June 23,
2011.
为什么 FDA CALENDER上没看到?
怎么查找明年年初的FDA CALENDER? 多谢 |
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