If the 6-month review is because the target population has increased to include children up to 18 years old, then it's a good sign.
If the 6-month review is because there are too much additional data that the FDA need to review in details, then it's not a very good sign.
Also 7 January 2025 is during x-mas and new year holiday period, where few people are on duty at work.
If a decision is made by the FDA there'd be a high likelihood that it will be made in December before everyone starts going away.
Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-56
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