If "real world" treatments are to involve multiple infusions of injections of MPCs, phase 3 studies MUST incorporate this into their design (e.g. 4 arm study with 1 infusion placebo or MPC; multiple temporally-spaced infusions of placebo or MPC). They cannot do a single-treatment study which shows modest results then extrapolate that to persuade clinicians to prescribe multiple treatments outwith trial conditions.
I haven't seen any of Mesoblast's Ph3 study protocols so can't comment further, does anyone have a link?
Also, I would not refer to the phase 2 results as "jaw-dropping". They are positive and suggest safety and efficacy, but I would reiterate that there is still a long way to go!
credible critique or not?, page-10
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