Looked up the patent and it seems to be running until 2013 only. http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=5506214.PN.&OS=PN/5506214&RS=PN/5506214 Merck didn't say what the FDA wrote in the RTF Letter but if it is another phase III trial, I doubt Merck are going to do it.