So in the July 25th PR, they said 'The assigned unblinded statistician team is currently analyzing the Data and the Company aims to submit the amended Study protocol to the FDA shortly thereafter'.
The Aug 16th PR indicates we are now in the 'shortly thereafter' timeframe. unfortunately terms like 'shortly' are relative. Could happen within a few days or shortly can be thought of as several weeks.
When the data access plan was submitted to the FDA for unblinding the 210, it (only) took them 18 calendar days to OK it. If they (FDA) have an idea what the new primary end point may look like it could be a similar timeframe once the new end points are submitted. I'm thinking the timeframe for approval of the amended Study protocol will put us around mid September. Hopefully the DSMB is looking at the updated end points and can have a recommendation ready as to whether to halt and unblind the overall study once the FDA approves. Maybe it will occur around the time that the u-Haul is loaded - say around Sept 19?
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