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First, you proved my point. My argument refereed to use of the...

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    First, you proved my point. My argument refereed to use of the terms subsequent vs eventual.

    Second, are you sure it was ODAC? I done a quick search and found an article that revealed the following:

    "The prostate cancer community has been waiting for the FDA's decision to approve sipuleucel-T since March 2007 (Nature Rev. Drug Discov. 6, 333–334; 2007). At this time, the FDA's Office of Cellular, Tissue and Gene Therapies Advisory Committee voted 17–0 that sipuleucel-T was safe and 13–4 in favour of its efficacy. However, in an approvable letter that the company received in May 2007, the FDA requested more information, including additional clinical efficacy data." https://www.nature.com/articles/nrd3205

    Also, Provenge (sipuleucel-T) wasn't included in the JAMA paper. You can look at eTable 2 to find all treatments included in the analysis. Redectane was for diagnostic purposes, so was excluded.

    I didn't realise there was a 100% success rate for FDA approval following a positive ODAC vote, but the JAMA article indicates a 100% success rate between the year 2000-2014 with the methodology of the JAMA article looking at treatments. My estimation of a 100% likelihood of approval for remestelcel-l was based on the criteria the FDA must take into account in order to approve the treatment. The only criteria they couldn't satisfy was efficacy, which ODAC voted 9-1 in favour of it showing efficacy.




    Last edited by Zenox: 04/09/20
 
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