CHF Accelerated Approval !, page-74

Just a reminder of what this thread is about.... as I see the orginal post was censored. In the latest conference call, SI conveniently avoided questions about a possible new trial for CHF. But the latest CHF announcement makes it clear they are looking to get approval based on the already completed trial. From the December 6 announcement:

"FDA guidance states that reliance on a single study to provide the substantial evidence of effectiveness necessary to support a Biologic License Application (BLA) is generally limited to situations in which a trial has demonstrated a clinically meaningful effect on mortality, irreversible morbidity, or prevention of a disease with potentially serious outcome for which confirmation of the result with a second trial would be practically or ethically impossible. Mesoblast will submit for formal FDA review the new data analyses showing the reduction in mortality and irreversible morbidity by rexlemestrocel-L in HFrEF patients with diabetes and/or myocardial ischemia, to agree on a potential pathway to approval."

The market quickly forgot about this gem when Novartis pulled out of the ARDS partnership, but MSB management certainly hasn't forgotten!

See the impressive stats in the announcement here:

https://hotcopper.com.au/threads/6468455/