Does anyone really think MRK isn't going to file an NDA this year
I ENTIRELY agree.
They have spent millions on the compound itself, millions more in clinical trial development. The drug showed p-value of .0001. At LEAST a 3 week PFS benefit (possibly more). As you and I have discussed, very likely subsets which are going to show tremendous benefit (others, not so much), and very likely a statistically significant benefit in OS. I'm sure there's more I am missing here, but....really. Considering all of the above, I cannot believe anyone actually thinks Merck would just abandon the indication because they would have 'reason to believe' ODAC would turn the indication down and Merck would get egg on their face in front of an FDA panel.
Merck is going to file, anyway you cut it. It would be foolishness for them not to, and, if they don't, I hope Ariad has some claw-back in the contract which would allow THEM to do it.
Technically speaking...I'm very disenchanted in the stock price, and lack of follow through and pessimism ARIA always gets. Mad I didn't sell at 7.00+? Yes. Think it's worth a lot more than $7.00+? Yes.
Does anyone really think MRK isn't going to file an NDA this year? After the rida cohort data is released at ASCO, imo, there isn't a chance that they won't file.
I respectfully disagree and think that the OS data have to show at least a strong trend in favor of the Rida arm for MRK to want to submit an NDA (#msg-60128136). Regards, Dew