|  Below is a summary of updates to the FDA decision calendar since my last article, which includes a total of 90 entries through today: 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 90 entries as of 2/23/09. The FDA Calendar includes the following information: company name, ticker, decision date, and description. The description includes a 1-3 sentence summary of the pending regulatory catalyst event with an example included below for BioDelivery Sciences (BDSI) with an expected decision date of 6/15/09: Onsolis (BEMA fentanyl) NDA Re-Submission for breakthrough cancer pain - $27M milestone payment if approved; small/dissolving polymer delivery system with opiate painkiller fentanyl designed for quick absorption through the cheek. The Clinical Trial Calendar includes 127 entries as of 2/23/09 and encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted. BioMedReports.com offers free and premium subscription options, with a $120 annual fee for access to over 200 entries for pending FDA decisions, clinical trial results, and pending re-submissions or new filings for FDA approval. The monthly average cost of just $10 is the same as an average online stock trading commission and compares favorably to competing reports at sites such as Revere Data , which charges $125 and $100 each per month for their FDA Approval and Biotech Pipeline research reports, respectively.
Aside from our much lower cost (at less than one-twentieth the cost of the two similar Revere Data monthly research reports ), the FDA and Clinical Trial Calendars at BioMedReports.com feature daily updates to the database and users have access on a dynamic basis through the website platform rather than a static PDF report which is issued on a monthly basis. Please note that many of the entries on these two calendars involve small and micro-cap stocks which represent high risk, high reward trades so it is prudent to avoid the temptation of going all-in, no matter how bullish you may be on the prospects for a company or new product. Also, many stocks begin to rise in price in anticipation of their PDUFA decision date or clinical trial results, presenting an opportunity to take profits ahead of the binary event. This risk-reduction strategy could involve selling out completely or just letting your profits ride through the binary event so your original investment is no longer at risk. Trading binary events (FDA decisions and clinical trial results) should be limited to the portion of your portfolio that is allocated for speculation and that you can afford to lose. 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 within three months of original decision date. A decision is now expected by 5/25/08 for the Company's resubmission of its Ampligen NDA, which is designated as an Orphan Drug for the treatment of chronic fatigue syndrome, which has no FDA-approved treatments on the market. Click here for a review article on the decades-long development of Ampligen and HEB will be presenting new clinical data at a medical conference on March 13. 3.) Schering-Plough (SGP): Saphris (asenapine) sublingual tablets response submitted 2/20/09 to the complete response letter from January 2009 for the acute treatment of schizophrenia in adults and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults as mono-therapy. SGP gave guidance for finalizing labeling discussions with FDA for approval, but no timeline was given for a final decision by the agency. 4.) Takeda Pharma (TKPHY) received FDA approval for the first new gout treatment in decades, which will be marketed as Uloric (febuxostat). 5.) Savient Pharma (SVNT) announced a three month delay in the review of its gout drug candidate Krystexxa (pegloticase) (formerly Puricase) with a new PDUFA date of 7/30/09 and a FDA Advisory Panel scheduled for 3/5/09. SVNT submitted additional data to the agency to improve its chances for approval, including a risk management plan, a bi-weekly dosing request, and more details on the cardiovascular side effects of the drug, which remain as the major overhang on the drug and focus of the upcoming advisory panel meeting. Below is a summary of updates to the Clinical Trial Results Calendar and pending FDA New Filings or Re-Submission with a total of 127 entries through today: 1.) Gilead Sciences (GILD): This past week, the FDA reiterated its stance on that GILD must conduct additional clinical trials before re-submitting the Aztreonam Lysine (inhaled formulation) NDA and there are currently two ongoing studies for the treatment of an opportunistic infection (P. aeruginosa) in cystic fibrosis patients. GILD expects to provide clarity on timelines for NDA re-submission at a later date. Complete Response Letters: 1.) Somaxon (SOMX) Silenor (doxepin) NDA - Filed under 505(b) Pathway - New Indication for an Approved, Generically Available Drug. Somaxon's new formulation of doxepin is at lower doses (1, 3, 6 mg) compared to existing generic products on the market at doses of 10mg-150mg to reduce the incidence of side effects - Complete Response Letter from FDA on 2/26/09 related to interpretation of efficacy data in the Silenor NDA - pending discussion with FDA to clarify next steps 2.) Theravance (THRX) Complete Response Letter (CRL) from FDA on 2/26/09 for telavancin in the treatment of complicated skin and skin structure infections (cSSSI). Telavancin is a once-daily injectable (IV) antibiotic for cSSSI and hospital-acquired pneumonia (HAP) caused by Gram-positive bacteria, including resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA). CRL requires a Risk Evaluation and Mitigation Strategy (REMS), data on patients with certain renal risk factors from the cSSSI and HAP studies, revisions to the draft label, and a safety update. The REMS will consist of a Medication Guide, a communications plan and a timetable for submission of assessments to ensure the benefits of the drug outweigh the risk of potential teratogenicity. A boxed warning related to this risk will be included in the package insert noting that females of childbearing potential should have a negative pregnancy test prior to administration. A post-approval registry of pregnant women exposed to telavancin will also be required. The letter indicates that telavancin, if approved, will be classified as pregnancy category C. The HAP data can be provided by cross reference to the recently submitted New Drug Application (NDA). The required revisions to the draft labeling include monitoring of renal function and cautionary language regarding the use of telavancin in patients with certain renal risk factors. | 
$44.02 (02/28/09)
