Replies to post #114803 on Biotech Values

[jq1234]

C'mon, seriously.

I am serious. When MRK doesn't talk about something, pay attention. For example, MRK partnered with CRME on vernakalant in early 2009. MRK filed MAA on IV version almost immediately, announced plan to initiate oral version phase III trial in 2010. MRK then stopped talking about oral vernakalant. Oral vernakalant is still in limbo today.

This is from ARIA press release, don't assume in biotech:

This trial remains active, and study participants continue to be followed to gather additional data on secondary endpoints, including overall survival and the safety profile of ridaforolimus. Merck currently plans to file for marketing approval of oral ridaforolimus in 2011, subject to final collection and analysis of all available data from the trial.

[DewDiligence]

…you actually think Merck wouldn't spend a few million more and file an NDA because they're waiting solely on OS? C'mon, seriously. They're going to file either way.

I agree with jq1234. In fact, I would go a step further and opine that, whether or not MRK ultimately decides to file, this NDA is not approvable without at least a positive trend in the OS data.