You'd have to ask The Australian
https://www.theaustralian.com.au/business/companies/us-food-and-drug-administration-acceptance-of-mesoblast-data-bodes-well-for-growth/news-story/5fe42675a3f284ef0665af1e914f8f2b
https://hotcopper.com.au/threads/australian-newspaper-article.8043663/page-38?post_id=74249617
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