Below are extreme trades among companies with stock prices under $5 from the BioMedReports.com FDA Calendar, which includes 238 entries as of 7/5/09. 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.
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. Another approach is to buy a basket of stocks well ahead of their expected binary events before the trading crowd arrives and causes an increase in the share price and trading volume. As with previous installments, this article is neither an endorsement of the companies profiled nor a complete list of extreme trades included in the FDA Calendar at BioMedReports.
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. Click here for more info at the FDA website regarding the regulatory approval process for medical devices.
On 6/30/09, AspenBio Pharma (NASDAQ:APPY) ($2.37) announced a 510(k) submission to the FDA for its AppyScore Test, which represents the first blood-based test designed as an aid in the diagnosis of human appendicitis with the proposed indication of use: AppyScore is an ELISA test system that is used to quantitatively measure S100A8/A9 heterodimer complex in blood. It is an in vitro diagnostic device that is intended to be used as an adjunctive tool for the diagnosis of acute appendicitis in conjunction with additional diagnostic modalities (such as clinical exam, basic lab testing, imaging) in patients with abdominal pain that is suspicious for acute appendicitis. This filing advances the Company's commercialization plan for AppyScore, which involves initially filing the 510(k) based on the ELISA test format.
Upon receiving market clearance for this device, the company plans to use the ELISA device as a predicate for a rapid assay device that includes a reader instrument. AspenBio plans to begin initial hospital testing of the rapid assay device in late 2009. Assuming the company receives FDA clearance of the AppyScore ELISA test and development work is completed, clinical trials of the rapid assay are planned to begin in early 2010. These follow-on trials will be designed to support a 510(k) submission for this rapid assay platform using the ELISA test as a predicate. The rapid assay system represents the format that APPY plans to ultimately commercialize.
In March 2009, BioForm Medical (NASDAQ:BFRM) ($2.07) announced the results of a clinical trial evaluating the mixing of lidocaine with RADIESSE dermal filler, which demonstrated an approximate 60% reduction of pain when RADIESSE dermal filler was mixed with lidocaine, and comparable safety and effectiveness of mixed and non-mixed RADIESSE dermal filler. The results were submitted to the FDA under a PMA supplement.
On 5/26/09, iCAD Inc. (NASDAQ:ICAD) ($1.23) announced it submitted data to the FDA seeking 510(k) marketing clearance of its VeraLook computer-aided detection (CAD) technology for CT colonography (CTC), or “virtual” colonoscopy. iCAD’s VeraLook product uses advanced algorithms to detect and highlight potential polyps warranting closer review by a radiologist. VeraLook has the potential to reduce oversight errors that could occur during review of a virtual colonoscopy exam, due to the large number of images (approximately 1500) generated by the CT system. By incorporating CAD with virtual colonoscopy, radiologists can use an image analysis tool that detects and marks potential polyps in an effort to improve detection of pre-cancerous polyps. VeraLook technology is currently available in Europe.
On 6/19/09, BioElectronics (OTCPK:BIEL) ($0.03) announced a corporate update, including the filing of two applications with the FDA. The first of these was for 510(k) marketing clearance for its Allay Menstrual Pain Relief Patch product seeking OTC marketing clearance and an indication for pain reduction associated with dysmenorrhea (period pain and cramps). The second FDA filing was for a reclassification of the Company's technologies from Class III to Class II. Over the next few weeks the management team expects to file two additional applications for 510(k) marketing clearance -- one for general plastic surgery recovery and one for foot/ankle/plantar fasciitis. After the general musculoskeletal disorder study is completed the Company expects to file an additional application covering all musculoskeletal disorders.
The Company also stated that it currently has about 720 million outstanding shares of common stock. On 6/15/09, BIEL announced that it is filing an application with the FDA for 510(k) clearance to market its Allay Menstrual Pain Relief Patch product. The Allay Menstrual Pain Relief Patch is drug-free and is based on Pulsed Electromagnetic Field (PEMF) therapy, which applies advanced semiconductor and micro-battery technologies into a very small form factor that has been packaged into a wafer thin patch that can be worn directly on the skin. BIEL.PK has experienced a major surge in its stock price and trading volume since the recent 510(k) filings and FDA Advisory Panel recommendations to lower the maximum daily dose of Tylenol (acetaminophen) and restrict higher-doses (500 mg or more) to prescription-only status.
On 11/14/08, Nephros (OTCQB:NEPH) ($1.40) submitted a 510(k) application to the FDA for approval of its HDF products for ESRD in the U.S. market. Following its review of the application, the FDA requested additional information, and Nephros replied to the Agency on 3/13/09. Per FDA guidelines, the FDA has 90 days to review the additional information provided by the Company, but a response from the Agency is still pending for the OLpur H2H Hemodiafiltration (HDF) Module and OLpur MD 220 Hemodiafilter. On 10/7/08, Nephros filed a 510(k) application for approval to market its Dual Stage Ultra-filter (DSU filters) to dialysis clinics for in-line purification of dialysate water. On 7/1/09, Nephros received approval of the DSU to be used to filter biological contaminants from water and bicarbonate concentrate used in hemodialysis procedures.
NeuroMetrix (NASDAQ:NURO) ($1.96): The ADVANCE NCS/EMG System is a comprehensive platform for the performance of traditional nerve conduction studies and invasive electromyography procedures. The system was launched during 2Q08 and is used primarily by neurologists, physical medicine & rehabilitation physicians, hand surgeons, and other specialists. NURO submitted a 510(k) application to the FDA on the (1) signal detector in December 2008 and filed an application on the (2) stimulator for the device in April 2009 for marketing clearance of a product designed to precisely deliver pharmacologic agents such as anesthetics and corticosteroids in close proximity to nerves for regional anesthesia, pain control, and the treatment of focal neuropathies.
On 3/9/09, Angiotech Pharma (NASDAQ:ANPI) ($1.65) presented complete data for the Bio-Seal study at the 2009 Society of Interventional Radiology in San Diego, CA. The trial hit its primary end point with clinical success in 85% of the treatment patients compared to 69% for the control patients (p=0.002). Based on info in the Company's 10Q filing on 5/8/09, data from this clinical trial study has been submitted to the FDA, which has responded to the submission with additional questions about the study. ANPI has responded to the FDA and upon further review by the agency, ANPI may either receive 510(k) clearance to market Bio-Seal in the U.S. or be required to respond to additional questions or conduct additional clinical studies. The product has already received CE Mark approval for marketing in Europe.
ANPI also has an FDA-approved dialysis catheter (HemoStream) that is sold through its direct sales force. A dialysis catheter is used for exchanging blood between a hemodialysis machine and a patient. Through the Company’s proprietary drug identification strategy, ANPI has identified 5-Fluorouracil (5-FU) as a compound that may help to prevent certain types of infection in patients receiving selected types of implantable devices, including certain dialysis catheters. ANPI is currently developing this 5-FU anti-infective technology for its HemoStream dialysis catheter line, and expects to file for a 510(k) clearance to market this product candidate in the U.S. during 2009.
Disclosure: No positions.