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BioMedReports: FDA Calendar Updates SPPI

73%

+20.59% in 4 hours <> <font> Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 240 entries as of 7/6/09. 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 BioMedReports.com, 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-stage clinical trial results... Continue reading »

By  Mike Havrilla   (+1.04%  risk: conservative)  07/06/09

Comment

Lixte Biotech (OTC:LIXT): Key 2H09 Catalysts Await SPPI

73%

+2.86% in 13 days <> Since I first wrote about Lixte Biotech (OTC:LIXT) at <font> BioMedReports.com in early April </font> , the Company has provided an update on its development-stage cancer drug discovery operations as part of a SEC 10Q filing in mid-May for 1Q09. LIXT.OB was originally founded as a diagnostics company in 2005 evaluating biomarkers (indicators of disease at the molecular level), but has shifted its focus to cancer drug discovery research that is primarily focused on the development of compounds for malignancies with few effective treatment options – such as certain types of brain cancer<><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><>... Continue reading »

By  Mike Havrilla   (+1.04%  risk: conservative)  06/23/09

Comment

20 Extreme Trades on Pending FDA Decisions SPPI

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-13.10% in 2 days (closed on 06/23/09) <> Below are 20 extreme trades among companies with market caps under $500 million from the <font> BioMedReports.com FDA Calendar </font> (database includes 225 entries as of 6/21/09) which have pending FDA decisions for either new drug products or biological agents that may have a major impact on each of the underlying stock prices. 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 highlig... Continue reading »

By  Mike Havrilla   (+1.04%  risk: conservative)  06/21/09

Comment

Bullish on SPPI ... SPPI

62%

+29.74% in 41 days 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. SPPI also has a pending sNDA for Fusilev (levoleucovorin) for Injection to expand use of the drug in combination with 5-FU containing regimens in advanced metastatic colorectal cancer. The PDUFA decision date for the sNDA is 10/8/09. Continue reading »

By  Marian Filo   (-24.55%  risk: aggressive)  05/26/09

Comment

New Index of Cancer Diagnostic and Therapeutic Stocks SPPI

73%

+130.15% in 70 days (closed on 06/21/09) By Mike Havrilla on 4/12/09 at BioMedReports.com   The table at the link below includes statistics for the 40 companies in the ETF Innovators Emerging Cancer Diagnostic and Therapeutic Stock Index, which is featured at BioMedReports.com in the health indexes section of the site. The index will track the performance of stocks with market caps below $200M at the inception date of 4/12/09 from a starting value of 2,632.   http://biomedreports.com/articles/most-popular/803-new-index-...   <> A World Health Organization report released last year es... Continue reading »

By  Mike Havrilla   (+1.04%  risk: conservative)  04/12/09

Comment

A Dozen Extreme FDA Trades on New Product Decisions SPPI

73%

+2.75% in 3 days (closed on 04/12/09) 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: http://biomedreports.com/fda-calendar.html   <> 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 ... Continue reading »

By  Mike Havrilla   (+1.04%  risk: conservative)  04/09/09

Comment

A Resurgence in Cell Therapeutics SPPI

73%

+26.24% in 7 days (closed on 04/09/09) Since I profiled Cell Therapeutics (CTIC) two months ago as a cancer biotech that was down, but not out; the stock price has more than quadrupled from 8 cents to 36 cents during intraday trading today. CTIC continues to reduce operating expenses and sold its remaining stake in a joint venture to market cancer drug Zevalin to Spectrum Pharma (SPPI) for $16.5M last month (in addition to receiving $15M last December from SPPI for the initial 50% stake).   http://biomedreports.com/bloglist/542.html   <> CTIC reduced operating expenses in 2008 by 33% and prov... Continue reading »

By  Mike Havrilla   (+1.04%  risk: conservative)  04/02/09

Comment

FDA and Clinical Trial Calendar Updates SPPI

73%

-0.00% in 6 days (closed on 04/02/09) Below is a summary of updates to the BioMedReports.com database of 245 entries included in the FDA and Clinical Trial Calendars .   Bio-Med Calendars: http://biomedreports.com/fda-calendar.html   <> 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 available with a total of 106 entries through 3/27/09. The FDA Calendar includes the following information: company name... Continue reading »

By  Mike Havrilla   (+1.04%  risk: conservative)  03/27/09

Comment

Updated Clinical Trial and FDA Decision Calendars SPPI

73%

+30.32% in 33 days (closed on 03/27/09) 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... Continue reading »

By  Mike Havrilla   (+1.04%  risk: conservative)  02/22/09

Comment

FDA Decision Calendar: Extreme Trades SPPI

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+0.00% in 7 days (closed on 01/24/09) FDA Decision Calendar: Extreme Trades   The table at my website link below includes an updated calendar of 78 expected FDA new product decisions with more detailed comments for each entry. Click here for a link to my previous FDA calendars and the list below highlights companies with pending decisions + market caps below $100M, making them ideal candidates for extreme trading opportunities.   http://www.etfinnovators.com/2009/01/fda-decision-calendar-ex...   <> BioDelivery Sciences (BDSI) – Onsolis approval is possible by mid-2009 and <><><><><><><><><><><><><><><><><><><><><><><><><><><><>... Continue reading »

By  Mike Havrilla   (+1.04%  risk: conservative)  01/17/09

Comment

Bullish on SPPI ... SPPI

77%

+301.23% in 248 days SPPI just signed an exclusive collaboration agreement with Allergan, Inc. for the development and comercialization of aqaziuoine.  They will receive $41.5 million at closing and up to $304 million in milestone payments.  When they receive the $41.5 million they should have over $90 million in cash which should be almost $2.85 per share in cash.  Also, they should be filing a supplemental NDA with the FDA  for their FUSILEV drug for colorectal cancer by the end of October 2008. Continue reading »

By  Darth Vader   (+2.12%  risk: conservative)  10/30/08

Comment

Bullish on SPPI ... SPPI

80%

+591.49% in 255 days SPPI will be filing an ANDA before the end of October and should sign a agreement with a Pharma company before the end of 2008 Continue reading »

By  Leonora Piper   (+4.19%  risk: conservative)  10/23/08

Comment

People Bullish on SPPI

Mike Havrilla Principal 73% about 3 hours ago	yuris73 Analyst N/A 14 days ago	Marian Filo Principal 62% about 1 mo ago
zkzachariah Analyst N/A 2 mos ago	blackbirdk01 Analyst N/A 3 mos ago

People Bearish on SPPI

biotech92 Analyst N/A 9 days ago

... more »  

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