1333248--3/16/2009--CADENCE_PHARMACEUTICALS

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{product, candidate, development}

{product, liability, claim}

We rely on third parties to assist us with our regulatory submission and other important aspects of our product development program, and our ability to obtain regulatory approval and commercialize Acetavance may be delayed if their performance is substandard or delayed, Changes made in scaling-up or transferring the manufacturing processes for Acetavance may result in a lack of comparability between our commercial product and the material used in our clinical trials, which could delay regulatory approval of this product candidate, substantially increase our costs We rely on our contract manufacturer to complete pre-commercialization manufacturing development activities, comply with stringent regulatory requirements and, if Acetavance is approved and commercialized, to produce Acetavance in the volumes that we require, and if our contract manufacturer fails to perform adequately or on a timely basis, our costs would be substantially increased and we may lose potential revenues; Acetavance may be found to have undesirable side effects that could delay or prevent its regulatory approval or commercialization; Recent publicity concerning the safety of certain drug products has resulted in heightened scrutiny We will require substantial additional funding and may be unable to raise capital when needed, which would force us to delay, reduce or eliminate our commercialization efforts and result in the loss of substantial revenues.

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1333248--3/16/2009--CADENCE_PHARMACEUTICALS_INC