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SVNT Analysis & Videos »
SVNT: Bull or Bear?
FDA Calendar Updates: BDSI, SVNT Deadlines Approach
SVNT
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+0.00%
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12 hours
(closed on 06/12/09)
<> Below is a summary of updates to the <font> BioMedReports.com FDA Calendar </font> , which includes a database of over 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of <font> BioMedReports.com </font> , the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-st...
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Updated Clinical Trial and FDA Decision Calendars
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-41.53%
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104 days
(closed on 06/12/09)
<> <> <> <>  Below is a summary of updates to the FDA decision calendar since my last article, which includes a total of 90 entries through today: <> The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA deadline dates. The entries are updated on a daily basis as new information becomes avai<><><><><><><><><>< />< /><><><><><><><><><><><><><><><><><><><>...
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Updated Clinical Trial and FDA Decision Calendars
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+18.32%
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6 days
(closed on 02/28/09)
Updated FDA and Clinical Trial Calendars By Mike Havrilla on 2/22/09 BioMedReports.com Below is a summary of updates to the FDA decision calendar since my last article, which includes a total of 90 entries through today: 1.) Nuvo Research (NRIFF.PK) (Canada: NRI.TO) NDA re-submission for Pennsaid - A topical NSAID for arthritis pain/inflammation - along with Paladin Labs (Canada: PLB.TO) <> 2.) Hemispherx Biopharma (HEB) Ampligen (Poly I: Poly C12U) NDA (three month PDUFA date delay announced 2/18/09 as additional data was submitted w...
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Updated Clinical Trial and FDA Calendar
SVNT
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+17.26%
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25 days
(closed on 02/22/09)
Updated Clinical Trial and FDA Calendar The tables at my website link below feature an updated calendar of 78 expected FDA new product decisions and 92 pending clinical trial result estimates + pending FDA re-submissions or new submissions for regulatory approval. Click here for a link to my previous calendars and below is a summary of FDA and clinical trial news since my last article. <> 1.) Watson Pharma (WPI): WPI received FDA approval for Gelnique, which represents the ...
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FDA Calendar: Allergan's New Rx for Eyelashes
SVNT
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-23.26%
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30 days
(closed on 01/28/09)
<> 
The accompanying table [click to enlarge] includes an updated FDA calendar of 65 expected decision dates included in the ETF Innovators [ETFI] New Drug Regulatory Catalyst Index, with six companies listed in red with overdue decisions and the possibility for five decisions during the coming week. Click here for my previous FDA calendar articles and below is a review of recent decisions + a preview of the coming week:
1.) Allergan (AGN) received FDA approval on Friday for Latisse (bimatoprost solution 0.0...
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Emerging Biotech & Pharma Index: 36 More Companies
SVNT
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-48.38%
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35 days
(closed on 12/28/08)
<> 
The accompanying table [click to enlarge or download] includes the 36 remaining companies in the ETF Innovators [ETFI] Emerging Bio-Pharma Index with market caps between $150M-$1.5B, which were not included in the previous two articles I wrote about the group – featuring the Top 40 Rated Companies and companies below the $150M market cap cutoff.
However, several of the companies included in the remaining group of 36 have been in the news recently due to FDA related news . Late last week, Ligand Phar...
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A Backlog of Decisions is Building at the FDA
SVNT
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+33.14%
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16 days
(closed on 11/23/08)
<> 
The accompanying table presents 70 FDA product approval decision dates along with the market caps and one year stock price change for the underlying companies. A note of caution for investors and traders is that the most common outcome from the FDA in the past year has been a delay in decisions due to understaffed conditions at the agency. However, several companies have pending decisions which are likely to occur either before year-end or early next year and will have a major impact on their stock prices.
Disco...
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Savient Pharmaceuticals Inc
SVNT
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-48.22%
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495 days
Savient Pharmaceuticals, Inc., a specialty biopharmaceutical company, focuses on developing, manufacturing, and marketing pharmaceutical products that target unmet medical needs. The company sells and distributes branded and generic versions of oxandrolone, which are used to promote weight gain following involuntary weight loss. It distributes the branded version of oxandrolone in the United States, under the name Oxandrin and authorized generic version of oxandrolone through an agreement with Watson Pharmaceuticals, Inc. The company is also developing Puricase, a Phase III clinical trial p...
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SVNT shorts will run for cover, but when?
SVNT
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-31.44%
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662 days
Short interest at over 11 million shares exceeds the float and would take more than 10 days to cover, at current volume. Any positive news at the Merrill Lynch Global Biopharmaceutical conference will place the short positions at greater risk. Will they cover or will they short more as the price rises? Eventually, they must cover. <> Near term news flow might include:
additional results from the two successful, recently completed Phase 3 studies;
a near term date for meeting with FDA
a firm date for BLA filing;
sublicensing Puricase(R) for < /><>...
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