oh my goodness @whytee. My heart!
I thought @wot had gone crazy by suggesting I was involved somehow. And then I said “ hold on one minute, wot is not crazy. Could it be but not limited to, Whytee.’
Took you off ignore & there your post was.
My humblest apologies wot for my initial reaction.
No, fda will make their decision on the letter’s request based on evidence. The BLA resubmission for approval is based on evidence & expert knowledge.
A Citizen’s Petition is simply one viewpoint. The FDA considers whether such petitions have merit, are factual (whether true or not) & applicable (within the FDA’s jurisdiction.
The link below takes you to a Citizen’s Petition that has been denied.
The letter from the FDA is addressed to a Mr Lassman.
https://downloads.regulations.gov/FDA-2021-P-0714-0008/attachment_1.pdf
Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-998
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