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Message: Re: No answer yet on what the change in study protocol is....

Here's my take. They are likely still in step 3 in my opinion or nearing step 4

Step 1: FDA tells Resverlogix that they can include US patients in BETonMACE if they adjust their protocol to meet A,B and C.

Step 2a: Resverlogix relays this info about FDA decision via news release

Step 2b: Resverlogix relays this info about FDA required adjustments to the BETonMACE Clinical Steering Committee

Step 3: Resverlogix/Clinical Steering Committee discuss the various ways to change the BETonMACE protocol that both meet the FDA requirements and minimize impact on the previous BETonMACE protocol. Importantly, there are likely many ways to change the BETonMACE protocol that meet the FDA requirements. 

Step 4: Resverlogix/Clinical Steering Committee decide on final plan

Step 5: Update the ClinicalTrials.gov and EU Clinical Trials register listings, and activate US study sites. 

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