1. MRK formed an internal cross-discliplinary team in October to expedite FDA approval. Would’ve been nice for them not to wait 6 mos. after they received their “breakthrough” designation, but at least it is in place now. This sort of news also puts pressure on BMS.
2. MRK is partnering with GSK for a trial combining PD-1 with a GSK drug (not Tafinlar or Mekinist) for a clinical trial for another type of cancer. This is a huge risk prior to FDA approval. Further evidence in my mind that MRK thinks approval is forthcoming in the near term.