The FDA are copping it from all directions and I can understand them being under extreme pressure
to quickly tick a box to get some drug into the chemist shops against the normality of extensive
trial protocols....I can understand their hesitancy....
In reality, they only are asking for a bit more "proof (bad word) to give them the confidence
to tick that box....
They would have "canned" it if they had concerns, minor hiccup and deflating IMO..Nothing more...
MSB to dispute FDA finding in Type A meeting, page-86
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