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Posted On: 10/10/2018 5:35:10 PM
Post# of 72440
PRV is usually awarded for Orphan Drug Designation diseases and other rarities as illustrated in Gamecock's link.
Also, the PRV is granted upon approval of the drug not upon awarding BTD or ODD. So even if B-OM was eligible, we wouldn't want to wait for B-OM NDA approval and then sale of the voucher to begin funding further trials.
Also, the PRV is granted upon approval of the drug not upon awarding BTD or ODD. So even if B-OM was eligible, we wouldn't want to wait for B-OM NDA approval and then sale of the voucher to begin funding further trials.
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