flipper44, you are correct, the compassionate use patient data will most likely be shared after the approval by MHRA, or as supportive appeal data if the MAA is refused, which I think is quite unlikely.
There are times there are dissenting medical opinions in the medical community about a trial's success and these are typically reviewed also by the RA which can take a little more time to investigate. Also when a trial has turns in it like when PFS was switched to OS, the review can be extended a little, though in this case there would have already been a decent review of the patient data at the time of the approval to change the endpoints. Final approval reviews are the be all and end all though for patient safety primarily as well as to catch anything else which may be questionable.
All in all this approval is a huge one for everyone involved including the MHRA. I had hoped for more rapid review based on the orphan and PIM designations but the backlog at MHRA has apparently swamped them for a while. NWBO will not rock any boats now if they have positive feedback from the RA and only take the approach to start to build a medical community support case if there is negative feedback. So I see the silence as good and as smart at this advanced stage.
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