Since we have not received such a PR, it is my guess that the MAA was not referred to the CHM because it has been encumbered by major objections.
Perhaps, it was referred to the CHM to consider all solid tumors...That is what I believe and I will certainly get ridiculed for it.
That is why I believe, the request for RWE was requested...Submissions end Monday so it's interesting the timing coincides with the new regulation on patient specific manufacturing....All those special patients and positive results will be considered in the approval process. To ignore those results is tantamount to malpractice IMO.
Hi meirluc, how confident are you that they would release a PR if the MHRA referred them to the CHM? Is there any chance they could withhold that information somehow? I really hope that’s not the case—just asking to reassure myself.