interesting how the FDA granted accelerated approval to a therapy
that is yet to demonstrate a clinical benefit.
Approval granted but with a confirmatory trial to be conducted so they can monitor results.
Mesoblast has proven clinical benefit , 4 year survival data and will run a confirmatory trial if approved. LVAD will chase AA and has proven clinical benefit. Both unmet needs .
At least pick examples that support your argument Doc, rather than ours.
Getting close to your $1.50 advice on approval too
Reg
2023 The Final Countdown, page-712
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