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
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https://www.regulations.gov/docket/FDA-2020-P-1689/document?sortBy=postedDate
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Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-971
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