Why did SI used word 'For approval' in the title? I checked the Jan 23 announcement and it didnt have ápproval' word in it. As far as I know, approval word was never used in any of the previous BLA submissions (please correct me if I am wrong) See below.
Do I conclude that this time is guaranteed or some kind of assurance from FDA that approval is sure thing! Just my personal opinion and not a financial advice.Ann: Mesoblast to File BLA for Ryoncil FDA Approval Next Week (yesterday)
vs
MESOBLAST RESUBMITS BIOLOGIC LICENSE APPLICATION (BLA) TO FDA FOR
REMESTEMCEL-L IN CHILDREN WITH STEROID-REFRACTORY ACUTE GRAFT
VERSUS HOST DISEASE (SR-aGVHD) (January 23)
vs
MESOBLAST INITIATES ROLLING SUBMISSION OF BIOLOGICS LICENSE
APPLICATION (BLA) TO U.S. FDA FOR REMESTEMCEL-L IN THE TREATMENT OF
ACUTE GRAFT VERSUS HOST DISEASE (May 29)
Ann: Mesoblast to File BLA for Ryoncil FDA Approval Next Week, page-105
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