Both and a lot more: "Barda is a 10 thousand pa
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"Barda is a 10 thousand page application one of technical and plans and trials in nature, it also covers manufacturing and distribution, in its entirety, everything covered, you don’t apply and then figure it out, you have to have everything done which is all partnerships complete, all manufactures committed with timelines and distribution partners like cvs and their clinics and pharmacies all in place and all need their deep plan included"