I think we are all a little confused on how the unblinding of the data works. I'm assuming it has to be done prior to meeting with FDA but not exactly sure of what the process is. Since the PR said they were confident they meet the enrollment protocol than maybe they can just have a call w FDA to unblind. Maybe they don't even need FDA approval to unblind.
Does anyone know how this process works? Might be worth asking Jody for those of you that can connect with her.
Michel- I don't know what arrangement they have with FDA now , Normally if protocol is for 30 patients study can be open after that . If they changed maybe until end of August we might have to wait couple more weeks , but I can not see we will need to wait until October 17 , but this is only IMO. If we don't have PE within few weeks I be really surprise !!!
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