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Biotech / Medical : sciclone pharmaceuticals -- Ignore unavailable to you. Want to Upgrade?

To: Guy Gordon who wrote (489)	3/23/2000 4:53:00 PM
From: AurumRabosa	Read Replies (1) \| Respond to of 1137

Excellent questions! If I answer them will you tell me how to make money in DWDM fiber optics ?:-) Does "orphaned drug" status affect how they get Zadaxin approved? No, they use the same FDA approval process. Does it make it any easier? Easier in the sense that a small company can feel safer in committing their funds to develop the orphan drug with minimal fear that someone else will beat them to market. Another drug can be approved later for the same ailment but I believe they would be held up to a tougher standard of safety, cost and efficacy. It also makes it easier because they can get grants to help fund the clinical trials. Are orphan products approved faster than other drugs? Historically the approval time for orphan products as a group has been considerably shorter than the approval time for all drugs. This is due to the fact that many orphan products receive expedited review because they are for serious or life-threatening disease. (From OOPD, see links below.) What is the difference between an orphan grant and an orphan designation? The orphan designation process is the mechanism by which sponsors of drugs and biologics for rare diseases qualify for the tax credit and marketing exclusivity incentives of the Orphan Drug Act. The Office of Orphan Products Development also administers a clinical research grants program, whereby researchers may compete for funding to conduct clinical trials to support the approval of drugs for rare diseases. (OOPD) Are orphan drugs exempt from FDA User Fees? Legislation reauthorizing FDA's user fees also created an exemption for orphan products from fees imposed when an application to approve the product for marketing is submitted. While orphans are not exempt from product fees or establishment fees, waivers can be requested where appropriate or necessary. (OOPD) Does it affect any of the "Phase..." studies? No. How does it affect the sales of the drug for other uses? It doesn't. The drug company is required to get an NDA approved for each indication they want to market the drug for. However, once the first NDA is approved doctors can prescribe it "off-label" for anything else they want. The only info the drug company can provide is what has been approved by the FDA. Read one of those flyers they insert in prescription drug packages filled with fine print, i.e. the label. How do you get tax benefits for its use against liver cancer, and also sell it for use against Hep. B & C? Orphan Drug Tax Credits The Orphan Drug Act encourages private research and product development for rare disorders, including many autoimmune diseases, by providing incentives both to ease the cost of drug development and to increase the prospects for capturing a reasonable profit from small markets. The two incentives used to encourage development of orphan drugs are (1) a research tax credit towards the costs of product development and (2) seven years of additional market exclusivity for approved products designated as orphan drugs. (AARDA) The Orphan Drug Act and Related Law and Regulations "...the credit determined under this section for the taxable year is an amount equal to 50% of the qualified clinical testing expenses for the taxable year." Doctors can prescribe it off-label for hepatitis B & C once SCLN gets an NDA approved for any indication. Maybe I should stick to DWDM fiber optics. At least I can understand that. I can understand the physics of fiber optics but what I could never understand is how broadband and fiber optics stocks can sell at such high P/S ratios. Your optical money making tips are welcome. Related Links: Office of Orphan Products Development fda.gov The Orphan Drug Act and Related Law and Regulations fda.gov American Autoimmune Related Diseases Association aarda.org Office of Rare Diseases (ORD) rarediseases.info.nih.gov The National Organization for Rare Disorders rarediseases.org NCBI - National center for Biotechnology Information ncbi.nlm.nih.gov Medical Transcription and Terminology Site mtdesk.com mtdesk.com