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The sponsor was informed of the above immunogenicity PMRs in the 9/23/2016 letter of labelling PMR/PMC comments and that PMR 3 through 6 are conditional based upon PMR3117-2 clinical results of ADA analysis. 3117-11 Assess development of anti-drug antibody ADA responses in plecanatide studies SP304203-00 and SP304203-03 and SP304203-01. 5 Endogenous mammalian peptides such as guanylin uroguanylin and lymphoguanylin have been demonstrated to bind to and activate GC-C. Use the validated assay...
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