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BioDelivery Sciences (NASDAQ: BDSI): Restarting the Catalyst Cycle
BDSI
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-21.08%
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54 days
BioDelivery Sciences (NASDAQ: BDSI) is a specialty pharmaceutical company that develops new indications for approved drug compounds by applying its proprietary drug delivery technology platform, BEMA (BioErodible MucoAdhesive) Film Technology, while seeking FDA approval through the 505(b)(2) pathway, which represents a lower risk / cost and quicker route to commercialization as compared to the process of developing new chemical entities or biological agents. BDSI focuses on the niche market of pain management and supportive cancer care. <> <> <font> <>http://www.mikehavrx.com...
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FDA Calendar Updates: Still Waiting on BDSI
BDSI
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-8.30%
in
93 days
(closed on 10/15/09)
<> Below is a summary of updates to the <font> BioMedReports.com FDA Calendar </font> , which includes a database of 258 entries as of 7/14/09. 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 pendin...
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FDA Calendar Updates: BDSI is Worth the Wait, Zicam Warning
BDSI
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+3.27%
in
5 days
(closed on 06/21/09)
<> 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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Save money, give stock to charity!
BDSI
+35.03%
in
175 days
Filed under: Palm Inc (PALM), Teva Pharm Indus ADR (TEVA), Stocks to Sell  Surviving this recession is foremost on peoples' minds, but giving to charity is especially important in times like these. So how can you effectively give while preserving your net worth? If you plan on liquidating any profitable, or taxable, positions in the stock market thanks to the current uptrend and also want to give to your favorite charity, the strategy outlined below is key to optimizing your gift, as well as your capital. <>Though giving cash to causes is the most popular form of charity, desperate times call f...
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FDA Calendar Updates: BDSI, SVNT Deadlines Approach
BDSI
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+0.63%
in
4 days
(closed on 06/16/09)
<> 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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(BDSI) FDA decision Friday June 12, 2009
BDSI
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-32.89%
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181 days
<> BDSI is awaiting a June 15, 2009 FDA decision date on its Onsolis breakthrough cancer pain drug. Onsolis is a fast-dissolving film applied to the lining of the mouth that delivers the potent painkiller fentanyl. The FDA sent a complete response letter on Onsolis last August requesting a risk-management plan for the drug. BioDelivery resubmitted Onsolis to the FDA in December. Commercial rights to the drug in North America and Europe were licensed to Meda AB, a specialty pharmaceutical firm. If approved, BDSI will receive $30 million plus double digit royalties upon Onsolis approval and co...
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13 Extreme FDA Trades: BioMedReports.com 6/1/09 Update
BDSI
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+15.34%
in
11 days
(closed on 06/12/09)
Below are 13 companies with market caps below $200M which have pending new drug product decisions 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 investing a small amount of money that you can afford to lose in a basket of stocks included in <font> Extreme FDA and Clinical Trial Calendar Trades </font> , which are highlighted in periodic articles at BioMedReports.com . <> <> ...
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Updated Calendar of 12 Extreme Trades on Pending FDA Decisions
BDSI
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-1.25%
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13 days
(closed on 06/01/09)
<> Below are 12 extreme FDA trades of companies with market caps below $200M 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 investing a small amount of money that you can afford to lose in a basket of stocks included in extreme <font> FDA and Clinical Trial Calendar </font> trades, which are highlighted in ...
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A Dozen Extreme FDA Trades on New Product Decisions
BDSI
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+51.21%
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40 days
(closed on 05/19/09)
Below are 12 companies with market caps below $200M which have pending new drug product decisions at 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. BioMedReports.com FDA Calendar: <> 1.) Vion Pharma (VION.OB): Onrigin (laromustine) Injection (formerly known as Cloretazine or VNP40101M) NDA (filed with the FDA on 2/17/09) with priority review request as a single agent for remission induction ...
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Bullish on BDSI ...
BDSI
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+10.27%
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245 days
BioDelivery Sciences International, Inc. operates as a specialty biopharmaceutical company in the United States. Its patented drug delivery technologies include BEMA drug delivery technology and Bioral cochleate drug delivery technology. The company, using its drug delivery technologies, develops and commercializes formulations of proven therapeutics for acute conditions occurring in cancer and surgical patients in the areas of pain and fungal infections. Its lead product includes BEMA Fentanyl for the treatment of breakthrough cancer pain. The companyÂ’s lead Bioral formulation is an encoc...
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Trading FDA Decisions: 14 Extreme Trades
BDSI
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+28.37%
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29 days
(closed on 04/09/09)
Below is a summary of companies from the BioMedReports.com FDA Decision Date Calendar which have market caps below $200M, making them ideal candidates for extreme stock price volatility trades as their decision dates become imminent. http://biomedreports.com/blog/Trading-FDA-Decisions-14-Extrem... <> <> Dyax Corp. (DYAX) secured a narrow approval from a FDA Advisory Panel in early February (with a 6-5-2 vote) for its Kalbitor (ecallantide or DX-88) BLA with a PDUFA date of 3/23/09, which is designated for priority review in the treatment of acute attacks of hereditary a...
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BioDelivery Sciences: A Bet on FDA Approval of Onsolis
BDSI
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+2.85%
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6 days
(closed on 03/11/09)
Posted by: Mike Havrilla in Untagged on Mar 05, 2009 <!-- Post Teaser Text --> <> While pending FDA new product decisions are never a sure thing, BioDelivery Sciences (BDSI) appears to have the odds stacked in its favor for approval of cancer breakthrough pain drug candidate Onsolis. <> BDSI submitted a Risk Evaluation and Mitigation Strategy (REMS) for Onsolis (BEMA fentanyl) based on the feedback it received from a complete response ruling by the FDA last August. Since the FDA has informe...
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FDA Decision Calendar: Pain Drug Delays Likely
BDSI
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-15.36%
in
23 days
(closed on 03/05/09)
FDA Decision Calendar: Pain Drug Delays Likely By Mike Havrilla on 2/9/09 ETF Innovators The tables at my website link below include an updated calendar of 86 expected FDA new product decisions and 89 pending clinical trial result estimates + pending FDA re-submissions or new submissions for regulatory approval. Click here for a link to my previous calendars. New FDA Decision Calendar Entries: <> 1.) Biogen Idec (BIIB) and Genentech (DNA) have a PDUFA...
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FDA Decision Calendar: 16 Extreme Trades
BDSI
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+3.43%
in
6 days
(closed on 02/10/09)
FDA Decision Calendar: 16 Extreme Trades By Mike Havrilla on 2/4/09 ETF Innovators Click here for a link to my previous FDA calendars and the list below highlights 16 companies with pending new product decisions at the agency + market caps below $150M, making them ideal candidates for extreme stock price volatility trades. <> BioDelivery Sciences (BDSI) – Onsolis approval is possible by mid-2009 and the Company raised $6M in cash from partner Med<><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><>...
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