Do you realise that Dr Halabi voted in favour of approval?
I expected her to go the other way, but was pleasantly surprised.
So on top of the overwhelming support of the clinicians, we also had support from the only biostatistician on the committee.
The FDA's decision was shocking and is completely unfathomable.
What's needed now is some very vocal support from the doctors and families of current and former patients.
I expect the FDA will be bombarded with correspondence complaining about the decision and the suffering it will cause. How can the FDA credibly deny that it will be responsible for that suffering given the overwhelming vote (advice) of its own panel of experts?
What a crazy state of affairs.
Cheers.
Ryoncil: ODAC/FDA Meeting Discussion, page-2045
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