As I mentioned, wish I knew the questions, so thanks for your sharing with me; I am outside waiting for the workers to show up as promised! Nice today & my daughter & son-in-law return this afternoon from Arizona where he had an event...thanks!
There are plenty of details for the rapporteurs to attend to besides whether they should have allowed a single trial MAA to be submitted in the first place.
You really have it backwards on regulatory standards, which lay upon the applicant and not the agency. And if there are no regulatory standards set forth by the agency in some regard, it will not magically appear during review.
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