Lykiri and Iwas, just to clarify the process in the UK a little more for those of us who know little about it, what does the UK call their equivalent to a BLA and when did NWBO start this filing? I presume that this is what you are referring to about hearing news before November in response to this filing - I assume that the RA in the UK is the MHRA?
The expected timeline for their answer for approval would be like a PDUFA date? What exactly does the NICE recommendations cover and is that from the MHRA as well, and is this something different than a plain vanilla approval?
Lykiri and Iwas, just to clarify the process in the UK a little more for those of us who know little about it, what does the UK call their equivalent to a BLA and when did NWBO start this filing? I presume that this is what you are referring to about hearing news before November in response to this filing - I assume that the RA in the UK is the MHRA?
The expected timeline for their answer for approval would be like a PDUFA date? What exactly does the NICE recommendations cover and is that from the MHRA as well, and is this something different than a plain vanilla approval?