Business
Mesoblast shares tumble again as investors pre-empt FDA – afr.com
The biotech’s management team will argue the case for approval of its cellular therapy at a make-or-break meeting with the FDA on Thursday.
Remestemcel-L also showed early signs of helping seriously ill coronavirus patients.
If approved, it would be the first allogenic stem cell product launched in a mega US market, where regulators are traditionally more sceptical over stem cell science. Mesoblast’s product is already approved in Japan.
The stock price tanked after the FDA released two briefing documents on Tuesday, which cast doubt over the clinical evidence.
OneVentures managing partner Paul Kelly said the FDA had pinged Mesob…
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