banter and General Discussion, page-7315

While we await the FDA decision on Remestemcel-L I have been re-reading some FDA documents in relation to FDA BLA resubmissions ....


Something that stood out given how often certain doctors on here have inferred that no real FDA review is done during the 60 days prior to the FDA issuing a Filing Letter was this in relation to the 74 day letter - a letter I might add that Mesoblast obviously didn't receive or they would have had to notify the market due to compliance of said 'deficiencies' contained within it, especially if they were major :


https://www.fda.gov/media/108895/download





Begs the question I guess that I am sure won't be answered - How could the FDA possibly 'identify deficiencies' in the Filing Letter if they didn't do some sort of review to ensure the resubmission was in fact a complete response to the original CRL prior to issuing same as outlined in the latest 8401.2 FDA SOPP document ? lol


Here's another short 5 page MAPP FDA document that might interest some to read while we wait detailing policy and procedures for FDA BLA resubmissions


GLTAH


https://www.fda.gov/media/72727/download