Biotech Values

[DewDiligence]

FDA is rescinding BTD for MRK’s HCV cocktail:

http://www.mercknewsroom.com/news-release/corporate-news/merck-announces-fourth-quarter-and-full-year-2014-financial-results

On Jan. 30, 2015, the company received notification from the FDA of its intent to rescind Breakthrough Therapy Designation status for this combination treatment regimen, citing the availability of other recently approved treatments for Genotype 1 patients.

This is likely to mean the FDA will conduct a standard rather than a priority review, adding approximately four months to MRK’s FDA approval date.