Apologies if this has been noted already, but The Australian's report on this includes comment from a Cantor Fitzgerald note on the ODAC questions predicting they will be adequately addressed by the company.
But analysts from Cantor Fitzgerald believed Mesoblast had sufficient data to allay the FDA’s concerns. “MESO has potency assays and experience from clinical trials to correlate this potency to measurable clinical outcomes,” the analysts said in a note to investors.“We think MESO will be able to address the concerns that were raised in the briefing materials. The topics of discussion were already anticipated by the company, and MESO has been preparing for the AdCom (advisory committee).”
https://www.theaustralian.com.au/business/companies/mesoblast-shares-plunge-after-us-fda-questions-covid19-treatment/news-story/dc53ea9b10c9de83c23b062e4572bc91
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Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L, page-549
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