As per Red - trial put on hold pending outcome of pediatric BLA.
Risk management of worst case scenario
Third CRL issued
Only way to prove up Remestemcel-l is to conduct an RCT in adults.
Why delay the trial when it's 5 times the paediatric market and funded.
Delay is non sensical unless they plan to scrap the entire aGvHD program- result - share price devastation - impossible to raise funds .
Or they have delayed because an approval in kids will lead to a label expansion in adults - same disease - potency varies by weight only. Real world evidence from the EAP and CIBMTR long term survival data.
Im not pumping- trying to get in the mind of the board.
Why the delay - Why the debt retirement
Im all ears for counter arguments
Reg
As per Red - trial put on hold pending outcome of pediatric...
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