Can someone remind me if this was debunked already? I thought ATL or someone confirmed we were not being reviewed under Orbis...I'd love to be wrong. And has anyone reached out to MHRA lately to see if their standard response has changed?
Gary, I don't know about Orbis being in the mix. All I know is that Linda said when submission was delayed that she would use essentially the MHRA MAA for submissions to other countries and that's why it had to be perfect. And I know everything seems to be moving faster than I expected in the US!