The Long and the Short of it All
July 15, 2009
We are presenting a list of companies which we believe are currently mispriced, based on our estimate of fair value, by the market. We develop our fair value ranges by projected free cash flow out one year and estimating an appropriate FCF multiple based on our assessment of risk and the strength of the balance sheet.
Cisco Systems [CSCO: 23.82, -0.1101 (-0.46%)] Recent Price $17.04 Value Range 21.86 – $38.41
Cisco Systems, Inc. designs, manufactures and sells Internet protocol (IP)-based networking and other products related to the communications and information technology (IT) industry, and provides services associated with these products and their use. Read more
FDA Calendar Updates: TRIB Awaiting Two Responses
June 23, 2009
Below is a summary of updates to the BioMedReports.com FDA Calendar, 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 BioMedReports.com, the FDA Calendar has expanded to include the following additional 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 pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval. Read more
BioMedReports FDA Calendar: Seven New Extreme Trades
June 22, 2009
Below are companies with market caps under $250 million from the BioMedReports.com FDA Calendar, which have either pending FDA decisions or pending clinical trial results 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 Extreme FDA and Clinical Trial Calendar Trades, which are highlighted in periodic articles at BioMedReports.com. Another approach is to simply buy such companies well ahead of their expected catalyst dates for a possible stock price increase as the date approaches and trading activity increases. Read more
FDA Calendar Updates: BDSI, SVNT Deadlines Approach
June 21, 2009
Below is a summary of updates to the BioMedReports.com FDA Calendar, 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 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 pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval. Read more
Access Pharma: Preparing to Advance Pipeline
June 21, 2009
Since I last wrote about Access Pharma [ACCP: 0.00, N/A (N/A)] two weeks ago as a cancer biotech call option trade, the Company has issued two updates on its clinical development pipeline and two updates for MuGard – which is an oral rinse product for the management of a common side effect of many cancer therapies, mucositis. In late May, Access announced that MuGard was launched in Germany, Italy, UK, Greece, and the Nordic countries by its European commercial partner, SpePharm, with expected launches in North America, Asia, and other regions slated for later this year. On 6/10/09, ACCP.OB also announced that the Company received issue notifications from the United States Patent and Trademark Office for two US patents (numbers 7,544,348 and 7,547,433). Read more
Seven Extreme FDA Medical Device Trades
June 20, 2009
Below is a sample of extreme FDA trades on pending medical device decisions (510k or PMA filings) among companies with market caps below $200 million which are taken from the BioMedReports.com FDA Calendar database. The FDA does not issue PDUFA decision date deadlines for medical device applications, which consist of the 510(k) and pre-market notification application (PMA) routes. The review period for PMA filings is typically more involved and longer than 510(k) applications. Read more
Stocks For An Economic Recovery – Healthcare
June 18, 2009
The medical equipment and supplies sub-sector of health care has come under significant pressure in the last 9 months or so. Big names such as Stryker Corp. [SYK: 47.43, -0.36 (-0.75%)], Zimmer Holdings Inc. [ZMH: 53.77, -0.73 (-1.34%)], and Medtronic Inc. [MDT: 37.97, -0.45 (-1.17%)] are trading at levels we have not seen in years. The whole aura of health care being “recession resistant” or “recession proof” is now thrown away and is an old folktale. Although these economic times are pretty much unprecedented, one thing is for certain: there has really been no safe place to hide in health care, except maybe to the likes of generic drug manufacturers such as Teva Pharmaceutical Industries [TEVA: 52.03, +0.41 (+0.79%)] or Mylan Inc. [MYL: 17.47, +0.05 (+0.29%)]. Read more
BioMedReports.com Extreme Trades: ACAD, ANPI, BSTC, RPRX, SNTS
June 16, 2009
Below are four companies with market caps under $200 million (all financial data current as of 6/9/09 during intraday trading) which have pending FDA decisions and/or clinical trial results 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 Extreme FDA and Clinical Trial Calendar Trades, which are highlighted in periodic articles at BioMedReports.com. Another approach is to simply buy such companies well ahead of their expected catalyst dates for a possible stock price increase as the date approaches and trading activity increases. Read more
NeuroSearch Experimental Obesity Drug to Begin Phase 3 Trials
June 14, 2009
As a trio of U.S. small-cap drug makers await crucial Phase 3 results later this year; NeuroSearch [NEUR: 0.00, N/A (N/A)] [NEUSF: 0.00, N/A (N/A)] is preparing to advance its own experimental weight loss drug to the final stage of clinical development following a successful End of Phase 2 meeting with the FDA which was announced earlier this week. Arena Pharma [ARNA: 3.49, -0.03 (-0.85%)], Vivus [VVUS: 7.39, -0.05 (-0.67%)], and Orexigen Therapeutics [OREX: 7.05, -0.01 (-0.14%)] are all awaiting Phase 3 clinical trial data expected during 3Q09 for their experimental weight loss drugs to support NDA filings for FDA approval, which are summarized and tracked in the BioMedReports.com FDA Calendar. Read more
FDA Calendar Updates: ABT, AFFY, AZN, LLY, MELA, PFE, SOMX, VPHM
June 13, 2009
Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of about 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 BioMedReports.com, the FDA Calendar has expanded to include the following additional 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 pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval. Read more
