Nope.
The FDA are in charge of approvals, not random petitions. They have their own processes , checks and balances that need to be followed.
They will review the BLA in accordance with regulatory practices. If there are any valid points in the petition, they would have already been looked at by the FDA as part of the review, and approval will answer any questions the petition may have created.
As you can see the petition is literally full of confounded questions that make no sense whatsoever, and baseless accusations made by someone who is not privileged to even know what has been done as part of BLA
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- Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L
Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-996
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