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Updated Calendar Report on Twelve Extreme Trades with Pending FDA Decisions - Biomedical news portal profiles 12 companies with FDA decisions pending - BioMedReports.com
Updated Calendar Report on Twelve Extreme Trades with Pending FDA Decisions

 

NewswireToday - /newswire/ - Pasadena, CA, United States, 2009/05/20 - Biomedical news portal profiles 12 companies with FDA decisions pending - BioMedReports.com.

   
 
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Today, in a new special report, BioMedReports.com- the news portal covering the biomedical news and financial sector- has researched and released the details of 12 extreme FDA trades for 11 companies with market caps below $200M- all of which have pending new drug product decisions or other meetings/milestones scheduled with the FDA that are expected to have a major impact on each of the underlying stock prices as the PDUFA decision dates approach and the decision is ultimately announced.

A high risk/reward trading approach to consider for speculative traders is covered in the report which features trades for:

• Hemispherx Biopharma (AMEX: HEB): Ampligen (Poly I: Poly C12U) NDA is an experimental treatment for chronic fatigue syndrome (which has no FDA-approved treatments) and the drug has an Orphan Drug Status with a PDUFA decision date of 5/25/09 (please note this is Memorial Day so the markets will be closed for a long weekend and re-open on Tuesday 5/26).

• Advanced Life Sciences (OTC: ADLS): ADLS has a pending NDA for cethromycin as a once-daily antibiotic for the treatment of adults with mild to moderate community acquired pneumonia (CAP) with a PDUFA decision date of 7/31/09. Also, the Anti-Infective Drugs Advisory Committee of the FDA is tentatively scheduled to meet on 6/2/09 to discuss the NDA for cethromycin and provide a recommendation for the final FDA approval decision.

• Spectrum Pharma (NASDAQ: SPPI): SPPI is a dual extreme trade with two pending decisions at the FDA. Zevalin sBLA (priority review) to expand the approved label to include consolidation therapy for follicular B-cell non-Hodgkin's lymphoma if a first-line treatment response is achieved with an expected PDUFA decision date of 7/2/09.

• Labopharm (NASDAQ: DDSS): A decision date of 7/18/09 is looming for the Company's rapid-onset formulation of trazodone (DDS-04A) for the treatment of depression through the 505(b)(2) regulatory pathway for new formulations drugs that are already on the market.

• Transcept Pharma (NASDAQ: TSPT): An expected PDUFA decision date of 7/30/09 is pending for Intermezzo (zolpidem sublingual lozenge) NDA for use as-needed to treat insomnia from middle of the night awakenings.

The full special report covering more details and profiles for all 11 companies can be found online.

About BioMedReports.com
BioMedReports.com is a news portal covering the biomedical news and financial sector. It features its own blog, discussion forum, stock research reports, news feeds, videos, press release capability, stock commentaries, and other unique content - including FDA and Clinical Trial Calendars.

Disclosure: No positions.

Certain sections of this report contain forward-looking statements that are based on our reporters' expectations, estimates, projections and assumptions. Words such as "expects," "anticipates," "plans," "believes," "scheduled," "estimates" and variations of these words and similar expressions are intended to identify forward-looking statements, which include but are not limited to projections of revenues, earnings, segment performance, cash flows, contract awards, FDA announcements, trial and drug approvals, and company stability. Forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. These statements are not guarantees of future performance and involve certain risks and uncertainties, which are difficult to predict. Therefore, actual future results and trends may differ materially from what is forecast in forward-looking statements due to a variety of factors including but not limited to the status or outcome of legal and/or regulatory proceedings.

All forward-looking statements speak only as of the date of this report or, in the case of any document incorporated by reference, the date of that document. All subsequent written and oral forward-looking statements attributable to the company or any person acting on the company's behalf are qualified by the cautionary statements in this section. BiomedReports.Com does not undertake any obligation to update or publicly release any revisions to forward-looking statements to reflect events, circumstances or changes in expectations after the date of this report.

 
 
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Updated Calendar Report on Twelve Extreme Trades with Pending FDA Decisions

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Publisher Contact: M. Garza - BioMedReports.com 
323-472-4480 garza[.]biomedreports.com
 
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