When a company like Anavex says something along the lines of:
“In parallel, we plan to proceed with the initiation of our confirmatory Alzheimer’s disease study,”
Such wording almost always refers to a new, prospectively controlled trial, not an open-label extension or ongoing long-term follow-up. Just like the FDA now insists on seeing initiated before granting an Accelerated Approval Mab. Boi would agree since this requirement is now found in guidance documents too.
You can of course always try to retrofit any statement to fit a sugar sandwich dream as this message board will and do all the time.