dennisdave,
NWBO hired contractors and experienced former regulatory consultants to help them put this together recognizing that they indeed had no experience doing this. What this tells me from the lengthy time it took to put everything together and prepare for possible questions with that help is that even experienced folks know they are breaking new ground and it just takes time to work through it all.
You and others seem to keep forgetting that this L trial, manufacturing processes and product release tech adjustments are likely being utilized as a likely template for all future similar treatment types that follow since one of the goals from oversight groups has been to create standardized guidance and standards for future reviews. Whether this has resulted in additional RFIs because that’s an MHRA option or just a slow overall process with back and forth will likely be made known at a later date but the clarification given recently about RFIs sure gives MHRA lots of room to work with as they try to figure out what they are going to do and how and when THEY are going to do it; ). That may mean they want to consider a little leapfrog with regard to additional evidence procured in the interim by NWBO and others too.
You, I believe, we’re legitimately concerned about NWBO trying to change the PIP while this application was under review but what If MHRA was willing to expedite the change now for the sake of getting an improved outcome for pediatric patients sooner after their MAA decision because of clinician support? When I try to think my best thoughts about all these folks that’s what I come up with. Best wishes.
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