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Accentia shares plunge on Phase III failure

Accentia Biopharmaceuticals disappointed its investors with a surprise announcement late Monday that a Phase III trial of SinuNase for chronic sinusitis had failed to hit its primary endpoint. The company's stock plunged 73 percent on the news, dropping to 81 cents a share. Officials for the company had expressed a significant amount of confidence in the therapy. The late-stage trial tested SinuNase in treating fluid buildup in sinuses.

But Accentia isn't abandoning the drug. "The company continues to believe that SinuNase is a viable product candidate for the treatment of chronic sinusitis, and a full data analysis of both the primary and secondary endpoints will be conducted in order to determine the next steps necessary in order to advance the product," Accentia said in a statement.

- see this release
- check out the AP report

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Comments

Abpi owns 70% of BVTI which has a market cap of $50 million, so at $1 ABPI is valuing its sinunase product and revimmune product at less than 10 million dollars. Either of these will produce $400 million a year in revenues when approved. This is a highly undervalued stock today. Sinunase will probably still be approved when it is tested against placebo in a pump spray formulation. The lavage study (80cc of fluid lavage would never be commercially acceptable to the public) showed superiority of sinunase to placebo, unfortunately, the washout of fungus by all that water in the placebo also had an effect. That is what all the fuss is about. When Accentia shows that sinunase does show objective and long term superiority to placebo in either a lavage or spray form, it will get approved. How could amphotericin not have more effect than plain water? But you don't have to wait til then to see ABPI pop. In a few weeks BVTI will announce its results on a novel treatment for non-Hogkins lymphoma. ABPI will follow BVTI up and look out shorts.

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