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The analysis method determined the likelihood of obtaining a statistically significant treatment effect at study completion, based on the data observed at this interim time point. Enrollment in the 60-patient open label Phase 3 trial is expected to complete mid-2017 with a read out in 2H CY 2017. Based on guidance from the FDA, Mesoblast believes that positive data from this Phase 3 trial may be sufficient for filing for accelerated approval of MSC-100-IV in the United States. Mesoblast plans to broaden the use of its technology platform in adult patients with high-risk steroid-refractory acute GVHD. Financial Results for the Six Months Ended 31 December 2016 (the half-year) (in U.S. Dollars) The Company has executed a range of cost reduction initiatives in order to offset the incremental costs of the MPC-150-IM program in FY2017. In line with this objective, operating cash outflows for the half-year FY2017 excluding MPC-150-IM for CHF were reduced by 22% (US$11.5 million) compared with the half-year FY2016. These reductions comprised: $3.4 million within Research and Development; $7.2 million in Manufacturing Commercialization; and $0.9 million within Management and Administration. Loss before income tax for the half-year FY2017 increased by $10.6 million primarily due to non-cash revenue items that do not affect our cash reserves, compared with the half-year FY2016. The main items which impacted the loss before income tax movement were: Revenues for the half-year were reduced by $10.6 million, of which $7.5 million was a reduction in a non-cash item. This non-cash item was deferred revenue recognized in half-year FY2016 related to our MPC-150-IM product. The remaining decrease reflects a one-off $3.5 million milestone payment in the half-year 2016 for TEMCELL [(R)] HS Inj. Research and Development expenses increased by $5.4 million, and were $29.0 million for the half-year FY2017 compared with $23.6 million for the half-year FY2016.