MRK—how long you think this delays the [Suvorexant] approval?
It looks like no new clinical trials are needed; however, MRK has to design and manufacture new 5mg and 10mg tablets and test them for stability, so I figure the delay will be at least 9 months. (Earlier today I said 6-9 months, but I now realize that range is too low.)
MRK’s response to the Suvorexant CRL is expected in 1H14, according to today’s 2Q13 CC. The long response time is to allow MRK to develop 5mg and 10mg tablets (which did not previously exist) and test them for stability.