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jaybe

02/04/15 9:36 AM

#186984 RE: DewDiligence #186981

A little background on FDA's guidance for rescinding BTD's...

http://www.lexology.com/library/detail.aspx?g=5316130e-d527-42ea-89e4-b6063687e494

jq1234

02/04/15 11:57 AM

#186999 RE: DewDiligence #186981

What about BMY's BTD for Daclatasvir +  asunaprevir +  BMS-791325? I assume it will be rescinded as well.

jq1234

02/06/15 9:52 PM

#187166 RE: DewDiligence #186981

MRK just posted this non-inferiority ph3 study of 2-DAA FDC vs Sovaldi + PI + R in GT1/4/6. It seems very likely to me FDA had requested comparator non-inferiority study for future HCV drug approval based on their previous comment/guidance:

https://clinicaltrials.gov/ct2/show/NCT02358044