858803--12/18/2006--AVANIR

related topics

{product, candidate, development}

{acquisition, growth, future}

{stock, price, share}

{regulation, government, change}

{regulation, change, law}

The FDA s safety concerns regarding Zenvia for the treatment of PBA/IEED may extend to other clinical indications that we are pursuing, including diabetic neuropathic pain. If our clinical trials for our product candidates are delayed, we would be unable to commercialize our product candidates on a timely basis, which would materially harm our business. If we fail to comply with regulatory requirements, regulatory agencies may take action against us, which could significantly harm our business. It is difficult to integrate acquired companies, products, technologies and personnel into our operations and our inability to do so could greatly lessen the value of any such acquisitions. We expect to rely entirely on third parties for international sales and marketing efforts. We depend on third parties to manufacture, package and distribute compounds for our drugs and drug candidates. The failure of these third parties to perform successfully could harm our business. Our stock price has historically been volatile and we expect that this volatility will continue for the foreseeable future.

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858803--12/18/2006--AVANIR_PHARMACEUTICALS