It is a confirmation that Grünenthal are sticking around and...

It is a confirmation that Grünenthal are sticking around and funding the additional trial that was always planned ..... The meeting with the FDA will be interesting given the opioid crisis in the USA and the recent SurgeCenter collaboration

..... and all the naysayers continue to embarrass themselves by saying Mesoblast have no partners - seems to me Grünenthal are 100% committed now .... and as for the constant Capital Raise suggestions in their 'the sky is falling' posts; yeah I don't think so ... lol



This seems like a clever strategy to me and probably why the Grünenthal $ were reduced .... I wonder if SurgCenter will provide the trial sites for this trial - seems logical ?


Mesoblast plans to leverage the results from a planned US trial to support potential product approvals in both US and EU by including 20% EU patients in order to provide regulatory harmonization, cost efficiencies and streamlined timelines, without initiating an EU trial. In line with this strategy, Mesoblast and its partner in Europe and Latin America, Grünenthal, have amended their collaboration agreement, with Mesoblast being eligible to receive payments up to US$112.5 million prior to product launch in the EU, inclusive of US$17.5 million already received, if certain clinical and regulatory milestones are satisfied and reimbursement targets are achieved. Cumulative milestone payments could reach US$1 billion depending on the final outcome of Phase 3 studies and patient adoption. Mesoblast will also receive tiered double-digit royalties on product sales as per the original agreement.