On the 21/12 MSB announcement in regards to RMAT designation for HF with LVAD.
FDA has invited Mesoblast to have a multidisciplinary comprehensive discussion as soon as possible....
So when will these urgent discussions take place? And could they be expanded to include our wider product range, MPC - 300- IV in particular!
I understand that we would have considerable evidence to support a P3 trial for the treatment of inflammation. Such a trial should not only test for controlling inflammation which would have a short end date and could be bought to market quite quickly, it could be divided into many subgroups of various conditions that cause inflammation. There would also be a large number of people suffering from adverse opioid conditions that our cells could benefit.
One treatment,one person, three trials! Funding of this trial, MSB probably can't afford however it is amazing were funds can come from when a plan is put forward.
FDA DISCUSSION
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