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Re: None

Tuesday, 06/27/2017 2:58:33 PM

Tuesday, June 27, 2017 2:58:33 PM

Post# of 44784
According to clinical trials dot gov, the Phase 1 trial for Incomplete HCT did not have an "actual study start date" until February 8, 2017. Yet according to their newest company presentation, they are expecting to have a data readout in H2/2017. This seems pretty ambitious. This trial is not estimated to be completed until May 2019. If this is the human safety data we are going to attach to our application for ARS approval, will we need to wait until this entire trial is completed? I don't think we will finish our final and larger NHP trial for ARS for at least 6mo-1yr, but where will the human safety data come from when we do and how much is needed? Will it come from early HCT trial participants, or Fukushima, NYBC, or all of them? Somewhere else?