And Dirk, who said anything about "shut down" or "refusal"? Not me. I have suggested the FDA will continue to be super cautious with ANDAs that involve third world country manufacturing by companies that demonstrate systemic problems with their systems and training. Like Dr Reddy's. No doubt they keep a close eye on GSK's "cheap" manufacturing done in Puerto Rico.
Re-read what I have written. I fear group-think is currently in action.
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