Document 6w4bGDXD85VXJo1oEdxRGxm46

PVJMEDICA Argus @-,ivision905 Sheehy Drive,Bidg,A @ Horsham, PA 19044 Tel2' @-,443.8)10 1Fox 215.443.8587 19 OCT 1 3 2n October 12,2000 Marvin T. Case,D.V.M., Ph.D. 'JM ToxicologyServices -'IMCenter,Building220-2E-02 St.Paul,N4innesota 55144-1000 Telephone: (651)7-'1')-5180 Telefax: (651) 7--)3-177--1 RE: Protocol418-009 - Combined Oral(Gavage)FertilitDye,velopmentaland Perinatal/PostnatRaelproductionToxicityStudyof N-ETFOSE inRats Dear Dr. Case: Enclosedisa copy of the issuedfinalReportAmendment I totheabove-referenced protocol. Ifvou have any questions,pleasedo not hesitatteo contactme. Sincerely, RGY:r2 Eric. Ray@mooiG. G. Yorkk,.Ph.D.,DABT AssociateDirectorof Research and StudyDirector Primedica Corporation 1 www.primedica-com Argus Research Laboratories,Inc. 905 Sheehy Drive,BuildingA Horsham, PA 19044 Telephone:(215)443-8710 Telefax:(215)443-8587 COMBINED PERRNATALIPOSTNATAL REPORT AMENDMENT 1 12 OCTOBER 2000 PROTOCOL 418-009 ORAL (GAVAGE) FERTILITY, DEVELOPMENTAL AND REPRODUCTION TOXICITY STUDY OF N-ETFOSE IN RATS FINAL REPORT AttachedisthecorrecteTdext FigureI totheabove-referencefdinalreport.Thischangereflects theadditionofa notationforthedosageadministrationftheF Igenerationratsand didnot affecttheresultsof thestudy. -L-I-@ Raa@o ond G. York, P DABT Associate Directoroffesearich and Study Director Date Nancy J.Gongliewski Date Manager of Regulatory Compliance cn cn E E cc cc cn 0 @.- CL 0 w LLI LLI LLJ 2 i2 zz 418-009-PAGE 1-4 REVISED PAGE M E E -2 z 'E 2