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Saturday, June 08, 2019 12:50:34 PM
“the FDA will strive to work with the industry to establish clarity around life-saving innovations in regenerative medicine."
this judgement gives a small “win” that FDA badly needed these days .. but in big picture it would be interesting to know what this KC’s “business as usual” line means! is it possible, USRM may’ve negotiated some favorable terms in an immediate leg up for their yrs of research work as it obviously working with undisputed success rate! all the argument was around it’s “drug” or not and if yes, there needs to be an approval.. so an edge there is all they need and it’s all be fully legit and widely accepted! just a speculation..
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