Rules manufactured to instill fear and parameters for companies and regulatory bodies to insulate and justify their actions similar to a Product Disclosure Statement "PDS" or warranty it carries very little weight its an attempt for companies to protect themselves and mitigate risk. I understand the series of meetings Mesoblast was engaged with the FDA however, an independent formal mediation attempt with the FDA would certainly provide the platform for Mesoblast to pursue litigation and would showcase their intent.
Ann: Change of Director's Interest Notice - Silviu Itescu, page-103
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