I was curious as to the ratio of BLA resubmissions that receive class 1 vs class 2 determinations. I found the answer in the FDA FY23 performance review.
For those also curious, in the last 5 years there's been less then 10 class 1 resubmissions in each year. Last financial year there were 9 class 1 and 64 class 2 which is just over 12% of resubmissions gaining class 1.
I would like to look up these class 1 resubmissions to determine any similarities between them and with our current situation but I can't find a list of them. If anyone has a shortcut to finding them I'd be all ears.
Be mentally prepared to hold for a further 6 months for the opportunity to be rewarded for your patience. Good luck all.
banter and General Discussion, page-9819
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