Absolutely. Unfortunately, approval is now based on a subjective opinion on wording and application processes and the FDA holds all the cards and can play them as they fit - at the expense of the SP and BOT's bottom line. It should never have come to this. For all the objective data and results the product can provide, I'm very nervous about the FDA's ability to say "yeah, nah, go again" in 6-9 month's time.
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Ann: FDA Letter Requires Patient Instruction Update, page-124
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