The company said it expects demand for Provenge to outstrip supply at launch, so doctors who participated in the Provenge phase III studies plus leading academic medical centers will be the first to prescribe the cancer vaccine to their prostate cancer patients.
All advocates should join the call for expedited approval from the FDA! The FDA promised CareToLive three times in its response to our Citizen Petition that it would expedite review as soon as it received all the data from Dendreon. They have all of the data as of October 30, 2009. This is not a new application. It is an amended (aBLA) application of the original filed in November 2006.
According to the FDA itself this has been an ongoing process since November 2006. The time for approval is now! They can get the review done quickly if they want to...and why shouldn't they want to.
Kerry M. Donahue
6295 Emerald Parkway
Dublin, Ohio 43016
6295 Emerald Parkway
Dublin, Ohio 43016
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