This is interesting, just my opinion but this would have been raised prior to the FDA approval. Is this a delay tactic to keep drug off market for 3-6 months and allow a takeover at cheaper price? Yes this would imply the FDA is not impartial etc.....but this feels suss to me. I'm going to suggest a takeover will occur prior to the next FDA review.
This doesnt pass the pub test for me. SP wont suffer much, it's still virtually an approval. Interesting few months coming.
Ann: FDA Letter Requires Patient Instruction Update, page-36
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