But JB - Your views never seem to consider
1 - Unmet need. 2 - No approved treatments.3 - High Mortility rate.4 - The efficacy that has been demonstrated through a mortality reduction.5 - The opinion of the treating doctor in an open label study.6 - The opinion of the ODAC who considered all of the above.
My question is - why don't you show how you have considered the above, in forming your opinion that you believe there is not enough evidence to approve.
banter and General Discussion, page-4700
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