Insightful Vinny.
Interesting closing statement by the head of Texas Heart Insitute - about THE FUTURE and the Use of allogeneic youthful cardiac stem cells.
Back on 1 July 2016, MSB provided an update on the3 CHF trial
" Based on observed HF-MACE event rates in the trial, the Company believes meaningful data will be generated by bringing forward to Q1 2017 a scheduled Interim Analysis to assess the trial’s primary endpoint between cell-treated and control patients. The results will be used to provide evidence based support for strategic decisions regarding the Phase 3 program, ongoing cardiovascular partnering discussions, and informed use of funds".
Vinny - what do you think "Based on observed HF-MACE event rates in the trial, " means ?
From my reading there have been MACE events ...enough to have an interim reading by QRT 1 2017. The question is where have the MACE events occurred ? In the placebo group or the MPC 150m control group ?No one knows the answer to this as we have been advised time over the results were not available to either MSB or TEVA.
On the one hand the DMBoard give the green light (based on 175 patients) for P3 to continue. On the other hand Teva hand back CHF to Meso (without ever explaining why ) – I can understand why people interpret this pessimistically.
Following FDA agreement , the P3 trial was enriched to treat the very sick patients ...
We know that in the P2 trial 15 patients were treated with the 150m MPC’s with no MACE at 36 months.
Make your own conclusions and determination.
Always DYOR and good luck to all.
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