Yeah, but limited availability for some reason. Why? Is it subject to ongoing scrutiny from the FDA or something? Why call it a 'De Novo' request - that's obviously different to a full throated application approval from the FDA for a new drug. "De Novo's" seem to be for a new 'device', so perhaps there is nothing new in the chemical being used, just how it is being applied? Also, they don't share cost/price on their website (I wouldn't expect them to) - but I wonder what a treatment would cost?
Yeah, but limited availability for some reason. Why? Is it...
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