IRENE KRISTAL, I, Plaintiff, v. MESOBLAST LIMITED, SILVIU ITESCU, and JOSH MUNTNER, Defendants., page-26

Has anyone thought that this could be a perfect outcome for mesoblast? If the FDA in previous discussions with mesoblast had in fact stated that the single arm study was sufficient for approval and mesoblast followed the fda guidance on the trial design, instead of mesoblast having to sue the FDA for not following their own guidelines, the FDA will be shown to have moved the goalposts as well as being biased in issuing a crl. Mesoblast will be able to disclose all the communication, minutes of conversations, letters of correspondence, in the writ and defence of its possible, and potentially put public pressured on the FDA to approve the product.
I do not for one minute believe mesoblast has made any misstatements in any of its communication.
The trial finished around while2016 in children they could easily at that point created a new trial for adults and we:d already have those results.
I personally think the FDA haven't been forthright in their workings for the CRL, and had probably hoped the committee would vote negatively but instead they had a 9-1 vote in favour and we now know the potential reason for the 1 negative vote.
Dyor not financial advise.