|I had this conversation with Chau a couple of months ago. He said that until EV had full approval with their phase lll trial, irrespective of AA, 132 has a clear runway to AA. Once getting AA, it doesn’t matter if EV gets full phase lll approval, 132, buy virtue of AA, would get it’s review out of the phase lll trial and could be approved by meeting it’s primary endpoints. BTD simply greases the path somewhat, but has no bearing on approvals. |
If EV got full approval through the phase lll trial before 132 got AA, then 132’s trial end points for AA or approval wouldn’t be valid.