Will AVANIR Pharmaceuticals continue to trend higher? |
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By Patrick Crutcher | |
Tuesday, 02 November 2010 03:34 | |
![]() AVNR received FDA approval for NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate), which is indicated for the treatment of pseudobulbar affect (PBA). PBA is a neurologic condition characterized by involuntary, unpredictable and disruptive outbursts of laughing or crying in patients with certain underlying neurologic diseases or injuries. We should note that the FDA approved only the 20/10mg formulation, not the 30/10mg. Additionally, there was no patient populations restrictions to MS or ALS patients only. Now that NUEDEXTA is approved, it also has the potential to be used off-label for diabetic peripheral neuropathy pain. This is a future indication AVNR will eventually be pursuing. Off-label use is likely to be negligible given that Medicare or insurance will not likely cover it. Ideally, AVNR will discuss the pricing for NUEDEXTA so that investors can begin modelling future revenue. One thing to keep in mind is that AVNR has a $75M shelf offering waiting to eventually be exercised; this shelf was made effective on October 28th. Disclosure: Long AVNR Initial Coverage - http://biomedreports.com/2010070746667/investors-warming-up-to-avnr.html Recent Q&A about safety data - http://biomedreports.com/2010101958490/safety-data-explained-for-upcoming-fda-decision.html AVNR Announces FDA Approval of NUEDEXTA - http://bit.ly/df686Y NUEDEXTA FDA Approval Conference Call Webcast - http://bit.ly/bPEDHI "Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'. Add this page to your favorite Social Bookmarking websites ![]() ![]() ![]() ![]() ![]() ![]() ![]() ![]() ![]() ![]() ![]() |