Will be interesting seeing early next year after meeting with FDA. If breakthrough status is granted there is every possibility this could be taken straight to market. Obviously there would still be some monitoring of patients but next year could get very exciting. We just don't know, we are all guessing at this stage. The only thing we know for certain is this company has not put a step out of place and as the results show they now how to conduct robust trials, unlike some other bio's.
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