What am I not getting here? Why was this a "bad" result from the market reaction (or was the reaction good until AF raised his red flags)????
As I read this, it sounds like out of the 167 enrolled, only 118 were deemed valid for the analysis. I thought that this seemed strange but don't you always have differences in enrolled vs analyzed due to the enrolled either dropping out, non-compliance with the regimen/study, and passing away before the study can conclude. I agree with AF from The Street that this is a red flag, but I would expect someone to address this disparity (otherwise it is a big red flag).
AF also mentions the lack of OS numbers...the release did have it. Also worth mentioning, the 88 number looks to be only those that did not receive additional treatment after the study regimen. This makes sense to me as getting additional treatment would make determining if a specific treatment worked nearly impossible.
From the release below:
"A number of patients on study received additional treatments with other agents following discontinuation of study treatment in accordance with the clinical practices of individual enrolling centres. Thirty of the 118 patients in the loco-regional group received at least one therapy with other agents after study therapy was discontinued. A greater number of patients in the control arm received post-discontinuation therapy versus the test arm. This imbalance created a "confounding," or distorting, effect on OS (Pazdur; The Oncologist 2008, 13:19-21), as such additional therapy can extend the patients' lifespan beyond that expected from receiving the study therapy. Eighty-eight loco-regional patients did not receive additional therapy and an analysis of these patients showed a median OS of 150 days (21.4 weeks) in the test arm (n=50) versus 115 days (16.4 weeks) in the control arm (n=38). "