re Svalis' postThat FDA guidance was issued in February 2018...

re Svalis' post

That FDA guidance was issued in February 2018 about 7 months prior to the commencement of the RCH trial (8/9/2018). It provided an opportunity for the company to act on the FDA suggestions in the guidance that companies planning trials for Duchennes consult with them about their plans. Unless I'm reading the HC threads wrong, it seems Sarepta probably did that without delay to help get their drug approved quickly, but there is no indication that ANP did. Had they done so it seems possible that the opportunity of arranging an extension of the RCH trial could have been taken up at that time ?