Ann: DSMB Analysis Recommends to Continue P3 COVID-19 ARDS Trial, page-304

SIR-spheres = Was classed as a "device" so took an easier path thru the FDA minefield, compared to "drug" pathways. Got approved for CEmark TGA and FDA without too many hiccups.
Cell based therapy a new realm which the FDA have showed they seem somewhat adverse too.......understanding?? ODAC was convinced by Ryoncil cept for Hinrich who appears to have the FDA's ear/pocket.
FDA were correct in questioning single arm trial, but endorsed it previously enough to give BLA submission, Did not indicate that 69% survival success from Phase 3 in children would not be enough to sway he stats for efficacy till the final hurdle....then pulled the rug out.
FDA seem to be treating it like the Rosetta stone......no compredo. FDA adverse to gene/cell based treatment approval.
Other market approval strategy may work instead...don't know why this has not been addressed by the company already for CEmark/TGA for Ryoncil, new capital funds should already be earmarked for this......why not? I would ask this question at AGM.
Occurence of Leukemia is worldwide lets focus elsewhere and leave the FDA holding the empty cot so to speak.
Why not target 1st worl economies with more forward thinking heathcare? Why not China/Asia/Canada/European Union....even Russia. Get some alternatives happening for market in roads...don't pin hopes all in on a dinosaur riddled archaic approval system which has already higlighted that even with expert advice on proven treatment without side effects in a feild where there is little alternative cept death. They hum and haa and go now bout we start from scratch again.........fark that.
If Type A rejected, no accelerated pathway is agreed to I feel its time to pull up the stumps for USA and present a new direction.
Either the Pharma industry there see's disruptive treatment a real threat to their script based gravy train of ongoing cashcows or the FDA is to Prolife conservative mindset to introduce any new gene/cell treatments. ok vented.
Market down...screen blank KZA was off to the races then............halted. Pah!!
Also forgot to mention MSB recieved huge accolades from the peer voted Biotech awards - Fierce, no avail.