RE: Expanded Access?4 Jan 2023 10:21
RAH - tend to agree that this isn't all that important. The FDA positively encourage expanded access to IND's and I suspect its not unusual for a developer to offer expanded access as part of a trial. It does strike me, however, that no physician is going to recommend a patient make use of expanded access without having at least some level of understanding about how safe it is and whether its actually doing anything, nor would I expect Avacta to allow it if they had any concerns (at least on safety/tolerability). I also wonder about the extent, if any, that data coming from anyone using expanded access might be used as part of the overall trial results.
Whatever, we don't actually know if any patient has made use of this potential so this is perhaps all a bit moot!