2023 The Final Countdown, page-2235

I will stick my neck out and say IMHO based on some of the FDA approvals I have seen this year (I have provided some examples previously but the obvious one is below) Mesoblast will receive at the very least an Accelerated Approval for <12 yo's ... this is not what the company wants but at this stage I would take this over a rejection any day ?


..... again IMO any lawyer 'should' be able to argue Remestemcel-L's case for an AA if a rejection was received based solely on this FDA Approval below ... if data from a mere 30 patients in total from 2 open label non-randomised single arm studies obtains a full approval then surely our data of more than 300 participants spread over the phase 3 trial and the EAP with now 4 year survival to boot would warrant at least an AA - we know there are no manufacturing issues now after the Lonza inspection so get on with it Mr FDA


GLTAH


https://www.fda.gov/news-events/pre...llular-therapy-treat-patients-type-1-diabetes

FDA Approves First Cellular Therapy to Treat Patients with Type 1 Diabetes


The safety and effectiveness of Lantidra was evaluated in two non-randomized, single-arm studies in which a total of 30 participants with type 1 diabetes and hypoglycemic unawareness received at least one infusion and a maximum of three infusions.




https://www.fda.gov/drugs/new-drugs...biological-products/novel-drug-approvals-2023

Novel Drug Approvals for 2023



https://www.fda.gov/vaccines-blood-...2023-biological-license-application-approvals


2023 Biological License Application Approvals