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poorgradstudent

06/28/17 2:14 AM

#212143 RE: Whalatane #212141

PRTO:

Their final P 3 tho is only with Radiocephalic fistulas and I believe at the highest ( 30ug ) dose .



From their own PR announcing Patency-1 failure, the description was:

"PATENCY-1 evaluated the safety and efficacy of a single dose of vonapanitase in patients with chronic kidney disease (CKD) receiving or expecting to receive hemodialysis who underwent surgical creation of a radiocephalic arteriovenous fistula."


From their PR regarding Patency-2, the description is:

"PATENCY-2 is a multicenter, randomized, double-blind, placebo-controlled study expected to enroll 500 patients in the United States and Canada with chronic kidney disease (CKD) undergoing surgical creation of a radiocephalic arteriovenous fistula for hemodialysis."


Both trials investigated 30 ug vonapanitase. So if the dosing is the same, and the patient population is the same, why should Patency-2 provide different data?