the day is young.
my take is that we know more than we did last week. We have confirmation that the most challenging approval hurdles have been met. We are facing a technical delay re: user instructions which is frustrating, especially the bureaucratic nature of addressing it. But this is an approvable product.
so I see this as: it’s de-risked relative to last week. Buy.
Ann: FDA Letter Requires Patient Instruction Update, page-111
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