Led wrote: "The adjustments have been agreed to according to the PR, so there's nothing left to settle."

Actually, the PR reads: "Resverlogix has agreed to make adjustments to the existing BETonMACE study protocol......"

Not exactly the same thing. Perhaps now that FDA has made its decision to allow US patients, the BETonMACE Clinical Steering Committee in conjunction with other regulatory bodies (i.e. EMA, FDA) needs to collectively decide how they want to adjust the study protocol. Just because the FDA relayed the minimum info/changes that they'd like to see doesn't mean that the Clinical Steering Committee has made their final decision in how to change the BETonMACE protocol. Give it some more time Led. My guess is you haven't heard back because either they haven't decided on the final changes yet or the final changes are still in the final approval process by all involved. My guess is that they will PR the changes and/or list them on ClinicalTrials.gov and EU Clinical Trials Register when ready.

BearDownAZ