So still looks on track to receive scientific advice from EMA mid year and then they can go away and properly plan and design the trial for submission and hopefully approval Q3 ? Maybe Q4 ? depending how many times it has to go back and forth. Would be hoping all approved and underway with first patient dosed by end of year ?
There is a little question mark in there right at the end though - how much material do they actually have on hand ? enough to carry out the IIb ? last time they tried to manufacture more material it was a huge bottleneck from memory ?
Ann: Trial Met Primary & Exceeded Secondary Endpoint Expectations, page-7
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