The Dendreon Corp. (DNDN) announced today it has completed the submission of its amended biologics license application (BLA) for Provenge to the U.S. Food and Drug Administration (FDA) (http://tinyurl.com/yzmx9qo).
Dendreon is seeking to have Provenge licensed for men with metastatic castrate-resistant prostate cancer (CRPC). Should the FDA follow the data this time around, Provenge would be the first product in the new therapeutic class known as active cellular immunotherapies.
Given Dendreon's announcement today, I hereby amend one of the statements in my Probabilities and the Financial Markets blog post: Basically, I now believe there is a high probability the FDA will be compelled to OK Provenge as a treatment for patients with metastatic CRPC by May 2 of next year.
Related Blog Posts
Probabilities and the Financial Markets (http://tinyurl.com/yzv7689)
Dendreon's Provenge: Maximum IMPACT (http://tinyurl.com/yzr2dor)
Congressmen Request Probe of FDA's Provenge Delay (http://tinyurl.com/ygfukge)
Sentiment Analysis: How Do You FEEL About It? (http://tinyurl.com/y93o7jy)
Dendreon CFO Pulls a Rabbit Out of the Hat, Again (http://tinyurl.com/yzrg33c)
Synchronicity! And Three Cheers for Ralph M. Steinman! (http://tinyurl.com/ylzxcm6)
Patient Advocates Plan Protest of Dysfunctional FDA (http://tinyurl.com/yk3qwvv)
Hey, Hey, FDA, How Many Dads Did You Kill Today? (http://tinyurl.com/ykuxrw2)
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November 2, 2009
Edited: November 2, 2009
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