Hi @nippy,
I understand OTP senior management work closely with leal and regulatory specialists e.g. its internal Office of Review Management and Regulatory Review. But OTP's own top-level structure has a fair degree of regulatory oversight built into it now. De-bottlenecking and harmonising of conflicting objecives are a couple of the reasons why OTP was formed. I could be wrong but I'm not sure having an external legal person ask pointed questions would really move things along that much faster in Type A (much less Type C) meetings. Could even slow things down atm.
But I was heartened to read in the 'paper article words along the lines of "...we re-presented our data to a group of the leadership around a table... ". That indicated to me that, as a team, senior OTP regulatory oversight is likely making certain the process stays on the rails this time. @Lopez has (IMO properly) mentioned a couple of times the significance of Dr N. Verdun - the Super Office Director - attending a sponsor-review team meeting in person.
I suspect the number of product development review meetings that Dr Verdun attends in person could be counted on a very few hands. And maybe even fingers.
Cheers
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