Apologies if this has been posted or discussed previously as I...

Apologies if this has been posted or discussed previously as I don't have the time to keep up with all the posts here lately. This point in motley fool's advertising, "It points out that the timing of the correspondence coincides with refreshed leadership at the newly formed Office of Therapeutic Products at the FDA." I wasn't aware of this?
Mesoblast Ltd (ASX: MSB)

Another note out of Bell Potter reveals that its analysts have retained their speculative buy rating on this biotechnology company's shares with a significantly improved price target of $1.40 (from 58 cents previously). Bell Potter notes that the FDA has used carefully chosen words to inform Mesoblast that the available clinical data from its Phase 3 study MSB-GvHD001 in children with steroid refractory acute graft versus host disease (SR a GvHD) appears sufficient to support a resubmission of the Biological Licence Application (BLA) for Remestemcel. It points out that the timing of the correspondence coincides with refreshed leadership at the newly formed Office of Therapeutic Products at the FDA. In light of this, the broker has renewed confidence for a prospective approval for Remestemcel later this year. It feels that a first approval may represent a gateway to a series of label expansions in the ensuing period. The Mesoblast share price is fetching 86.7 cents on Friday."

Bold highlight is mine.