Yep, looks like I was spot on about the product labeling.
Short term blip. To be honest I'm used to this with Botanix. Never smooth sailing.
Certainly a character building stock.
However I have been in since the Bone Medical days. About as good as a CRL could be.
This will chop around today, but approval is near guaranteed now and only labelling is the issue.
Big pharma will certainly be watching.
But to miss the product use instruction.. if I don't laugh I'll cry.
Hold strong my friends.
Ann: Presentation- FDA Letter Requires Patient Instruction Update, page-11
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