Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-971

I note Lassman Law haven't lodge any additional supplements after their 5 December 2022 protest submission, which jumped the gun by the way given they claimed that the 2 October IND File submission was insufficient through this sentence:


"including data submitted in Mesoblast’s most recent filing - fails to meet the rigorous standards necessary to qualify as “substantial evidence” of effectiveness under the Public Health Service Act (“PHS Act” and Food and Drug Administration (“FDA” policies."


Sound familiar ? Making claims that data submitted to the FDA was insufficient without actually knowing just what that data was - I mean how could they ? lol


.... perhaps even Lassman Law now think it would be difficult to argue against the independent 4 year survival data ?


GLTAH






https://www.regulations.gov/docket/FDA-2020-P-1689/document?sortBy=postedDate