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When Did Phase 3 Studies Begin for TMC435, BI201335, GS7977, BMS790052, and PegLambda and when will they finish & receive FDA approval.
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About 2 years is the length of time from beginning to end of the studies
most started in 2011 so 2013 will be when studies will begin the preparing for FDA approval, collecting final data and submitting to FDA
Tibotec Starts Global Phase 3 Clinical Trials Studying TMC435 in Adults With Chronic Genotype 1 HCV
-Phase 3 program for once-daily TMC435 includes treatment-naive population and patients who have relapsed after prior interferon-based treatment-
http://www.natap.org/2011/HCV/022211_01.htm
CORK, Ireland, Feb. 18, 2011 -- Tibotec Pharmaceuticals announced today that two global, registrational phase 3 trials are recruiting patients to examine TMC435, its investigational hepatitis C protease inhibitor, in treatment-naive adults with chronic genotype 1 hepatitis C virus (HCV). A third global phase 3 trial is being conducted in genotype 1 HCV patients who have experienced a viral relapse after prior interferon-based treatment.
Boehringer Ingelheim completes patient entry for Phase III trial programme in Hepatitis C
http://www.natap.org/2011/HCV/121011_03.htm
INGELHEIM, Germany, December 9th, 2011 - Boehringer Ingelheim today announced that the final patient has been randomised to treatment in the large-scale Phase III clinical trial programme for BI 201335, its investigational, oral protease inhibitor for the treatment of chronic hepatitis C virus (HCV).
Gilead Begins Single Pill Hepatitis C Study for 2014 Approval
http://www.natap.org/2012/HCV/072712_01.htm
July 27, 2012
we anticipate being able to file for regulatory approvals for GS-7977 by the middle of next year........If successful, the initial indication will for 12 to 16 weeks of treatment with GS-7977 and Ribavirin in genotype 2/3 infected patients, and for 12 weeks of treatment with GS-7977, peg-interferon and Ribavirin in genotype 1, 4, 5 and 6 infected patients......The fixed dose combination regulatory filings could, in that case, follow the initial GS-7977 filings a year later by mid-2014
The investigational direct acting antiviral BMS-790052 is now in Phase III development.
The investigational direct acting antiviral BMS-790052 is now in Phase III development.
PRINCETON, N.J.-Sept 17, 2011, The investigational direct acting antiviral BMS-790052 is now in Phase III development.
http://www.natap.org/2011/ICAAC/ICAAC_19.htm
BMS-790052 Plus Peginterferon Alfa and Ribavirin Demonstrated up to 83% Sustained Virologic Response 24 Weeks Post-Treatment (SVR24) in Phase II Study of Genotype 1 Hepatitis C Patients
Phase 3....Safety and Efficacy Study of Pegylated Interferon Lambda Versus Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C
http://clinicaltrials.gov/ct2/show/NCT01447394
Study Start Date: March 2012
Estimated Study Completion Date: August 2014
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