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FDA Calendar Update: Acusphere (OTC:ACUS), Cephalon (NASDAQ:CEPH)
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<> Below is a summary of updates to the <font> BioMedReports.com </font> database of over 200 entries included in the <font> FDA and Clinical Trial Calendars </font> . The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA fo>...
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Bullish on ACUS ...
ACUS
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n/a
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44 days
(closed on 06/25/09)
I'm seeing ACUS down at around $.37. After the recent run up to $.50 plus I'd consider this a bargain up until May 31st.
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Bullish on ACUS ...
ACUS
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Acusphere, Inc., a specialty pharmaceutical company, develops new drugs and formulations of existing drugs using its proprietary porous microparticle technology in the United States. Its porous microparticle technology enables to control the size and porosity of particles, including nanoparticles and microparticles. The company develops products in the areas of cardiology, oncology, and asthma. Its lead product candidate Imagify, a cardiovascular drug is in Phase III clinical development for the detection of coronary artery disease. The company?s products also include AI-850, a Phase I clin...
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Acusphere: A Closer Look at an Extreme FDA Trade
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(closed on 05/15/09)
The following article was contributed to BioMedReports.com by Michael Vlaicu and edited by Mike Havrilla for publication on 5/9/09. The article takes a closer look at an <font> upcoming extreme trade </font> on a pending FDA new product decision for Acusphere, Inc. (OTC:ACUS) . <> Continuing the FDA journey to riches, I have chosen ACUS as my next prime target. I see alot of benefit and potential in this company, not only from its currently cheap PPS, but also from the vast potential market. The time is now to load up on this company (if you haven’t already><>><><>>><>><><>><>><>>><>><><>>><>><>><>><>><>><>><>><>><>><>><>><>><>><>><>><>><>><>><>><><><><>>><><>>>>>...
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Blockbuster Potential!
ACUS
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508 days
<> For over ten years Acusphere has been working towards this day! Imagify, their lead product, has the potential to replace nuclear stress testing in the diagnosis of CAD(coronary artery disease). It costs less, is faster, can be done in the Cardiologists office with existing Ultrasound equipment and is radiation free! Over 1000 applications worldwide have proven that it is safe and diagnostically equivalent to nuclear. The NDA has been submitted AND accepted by the FDA. As we approach approval of this drug the price will soar. An announcement of a financial partnership should soon solve any><>><>><>><>>...
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From the Blogosphere
Updated FDA Calendar: Buying Cypress Bioscience
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The accompanying table [click to enlarge] includes a weekly update of 71 expected FDA decision dates as part of the ETF Innovators [ETFI] New Drug Regulatory Decision Catalyst Index. Since my article last week, the following action has taken place at FDA:
1.) Pain Therapeutics (PTIE) & King Pharma (KG) lost 21% and 7%, respectively, today after receiving a complete response letter from the FDA for their abuse-resistant form of controlled-release oxycodone, which is designed to deter the abuse and diversion of the blockbuster pain drug OxyContin sold by privately-held Purdue Pharma.
While deta...
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Updated FDA Calendar: Buying Cypress Bioscience
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The accompanying table [click to enlarge] includes a weekly update of 71 expected FDA decision dates as part of the ETF Innovators [ETFI] New Drug Regulatory Decision Catalyst Index. Since my article last week, the following action has taken place at FDA:
1.) Pain Therapeutics (PTIE) & King Pharma (KG) lost 21% and 7%, respectively, today after receiving a complete response letter from the FDA for their abuse-resistant form of controlled-release oxycodone, which is designed to deter the abuse and diversion of the blockbuster pain drug OxyContin sold by privately-held Purdue Pharma.
While deta...
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Eyeing Opportunities in Micro-Cap Bio-Pharma Index
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 <> The accompanying table profiles the 13 companies mentioned in this article and statistics for all 113 companies [click here for a link to the entire index] with market caps between $25M-$150M, which are included in the new ETF Innovators [ETFI] Micro-Cap Bio-Pharma Index as a complement to the ETFI Emerging Bio-Pharma Index of companies with market caps between $150M-$1.5B.
The Micro-Cap Bio-Pharma Index was hit especially hard over the past year, posting a decline over 41% while the Emerging Bio-Pharma Index fared somewhat better with a 30% loss. Over the past year, benchmark healthcare ETF>...
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Eyeing Opportunities in Micro-Cap Bio-Pharma Index
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 <> The accompanying table profiles the 13 companies mentioned in this article and statistics for all 113 companies [click here for a link to the entire index] with market caps between $25M-$150M, which are included in the new ETF Innovators [ETFI] Micro-Cap Bio-Pharma Index as a complement to the ETFI Emerging Bio-Pharma Index of companies with market caps between $150M-$1.5B.
The Micro-Cap Bio-Pharma Index was hit especially hard over the past year, posting a decline over 41% while the Emerging Bio-Pharma Index fared somewhat better with a 30% loss. Over the past year, benchmark healthcare ETF>...
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High-Risk Buy Rec for Acusphere
ACUS
+0.00%
in
3 hours
(closed on 06/30/08)
We still believe Imagify is a potential blockbuster product for the detection of coronary artery disease.
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