I Located this article following the approval from the advisory...

I Located this article following the approval from the advisory committee and just noted the following parts from the article got me a little nervous. Saying this, would have the below been addressed which resulted in the 9-1 support for approval? I just hope the FDA don’t stand firm on there below opinion and request further trials as supporting evidence. Any thoughts on this ? not down ramping. Currently a holder.

https://www.businessnewsaus.com.au/articles/major-breakthrough-for-mesoblast-as-fda-advisory-committee-backs-rynocil.html

“On Monday the FDA said while the product has shown apparent immunomlatory effects in in vitro experiments, its ability to "reduce inflammation as measured by inflammatory biomarkers in humans receiving the product has not been demonstrated"."A relationship between these in vitro lot release assays and the clinical effectiveness of the product has also not been demonstrated," the FDA said.The FDA also stated the critical quality attributes (CQA) of the therapy may not be sufficient to ensure the manufacturing process consistently produces remestemcel-L lots of acceptable quality."Characterisation of cell-based products in general is complicated by the complex nature of cells relative to other types of drugs, as well as heterogeneity among cells comprising the active ingredient," the FDA says.