Someone not paying attention to the news.
MSB just got FDA RMAT designation in an area of orthopedics in its Mesenchymal treatments:
Melbourne, Australia; February 9 and New York, USA; February 8, 2023: Mesoblast Limited
(ASX:MSB; Nasdaq:MESO), global leader in allogeneic cellular medicines for inflammatory diseases,
today announced that the United States Food and Drug Administration’s (FDA) Office of Tissues and
Advanced Therapies (OTAT) has granted Regenerative Medicine Advanced Therapy (RMAT) designation
for rexlemestrocel-L in the treatment of chronic low back pain (CLBP) associated with disc degeneration,
in combination with hyaluronic acid (HA) as delivery agent for injection into the lumbar disc.
RMAT designations aim to expedite the development of regenerative medicine therapies intended to
treat, modify, reverse, or cure a serious or life-threatening disease or condition where preliminary
clinical evidence indicates that the drug has the potential to address unmet medical needs for the disease
or condition. An RMAT designation for rexlemestrocel-L provides all the benefits of Breakthrough and
Fast Track designations, including rolling review and eligibility for priority review on filing of a Biologics
License Application (BLA)
That suddenly makes RGS' IP a lot more valuable and this stock potentially a bit too cheap for all of its executives' shortcomings.
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