Surgcenter deserve a seat at the table, can they steer the ship...well SI is a hard nut to crack. Partners come and go...history shows. Seriousquestion is both the CLBP and CHF P3 trials failed to meet their primary endpoints so more expense to redesign and start trials, funds will soak up fast.
Data mining post hoc leads to secondaries becoming the new "cure" this means prove it again by way of more trials...was Surgcenters timing good or bad? They would have got north of 84 million stock at todays prices [they got 60million]...their investment saved MSB wheeling out the cap raise barrow again to insto's.
Surgcenter specialize in orthopaedics...MSB stated they would use funds to advance other candidates and increase inventory?? Why increase when you have no approved product to market?
June 30 - Mesoblast has filed a request and expects to hold a Type C meeting with the US Food & Drug
Administration (FDA) during the current quarter to discuss the pathway to US regulatory approval for
rexlemestrocel-L following the recently completed 404 patient Phase 3 trial in patients with chronic
inflammatory back pain due to degenerative disc disease.
Aug 31 2021 - Rexlemestrocel-L in the treatment of chronic heart failure and chronic low back pain:
• Mesoblast expects to receive feedback from the FDA in the next quarter on the potential
pathways to US regulatory approval for its rexlemestrocel-L technology platform following the
recently completed Phase 3 trials in patients with chronic heart failure and chronic low back
pain (CLBP) due to degenerative disc disease
• Mesoblast and its partner for CLBP in Europe and Latin America, Grünenthal, amended their
collaboration agreement in line with a strategy to achieve regulatory harmonization, cost
efficiencies and streamlined timelines aiming to leverage the results from a planned US trial in
support of potential product approvals in both US and EU
Planned US trial plain and simple so 2 yrs from now after trial design,recruitment readouts etc etc. No sure where the SP will be then could be 50c could be $5.00 but the product to market timelines are over the horizon. I'm a bit over the hype machine after the black n white showed a red light. Consequently reduced holding alot to a toe in the water and directed my funds elsewhere after bailing most at 2.75. From star pupil to naughty chair, all imo.
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