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The FDA retains full discretion to accept, modify, or reject the recommendation, and formal inclusion on the 503A Bulks List requires a separate FDA rulemaking process with no announced timeline - legal analysts covering the vote have noted that a final rule could realistically take many months to over a year to materialize

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Studies have pointed to activation of the ERK1/ERK2 signaling pathways alongside VEGF as relevant to wound repair and regeneration, contributing to its use across burn, skin injury, and soft tissue damage models — though researchers note the dataset specific to wound healing remains comparatively limited

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