Replies to post #131901 on Biotech Values

[acgood]

Thanks - I don't follow this trial/company closely either, but your statistically-informed takeaways closely mirror my gut-feeling reaction based on this PR.

[TastyTheElf]

And these results should put a damper on that thinking since 0.69 is a HR that would have been passed had the trial been running as long as contended (factor of >=2x was the contention) due to treatment being a miraculous cure.

It certainly means that RFA has improved a lot in the last 5 or so years... if the HR was higher than .69 at the interim look, and the modeling is roughly correct (assuming constant hazard rate), I think it forces median control PFS comfortably over 18 months.

That would be consistent with the Chinese meta-analysis we talked about awhile back.

[pcrutch]

Curious what the CEO is trying to say here.

The DMC evaluated data from 613 patients in its review, and also conducted a formal interim analysis. A total of 380 events of progression, which are projected to occur in late 2012, are required to reach the planned final analysis of the study. An important element of the independent committee's review was the statistical method used to conduct the analysis. During the opening session of the interim analysis meeting with the DMC, the Company defined and the DMC implemented a monitoring boundary for interim and final analysis. In the closing session it was noted by the DMC that additional interim efficacy analyses could be conducted with a de minimis statistical penalty if the company so chooses. As a result, the company is pursuing an additional preplanned efficacy review prior to the final PFS efficacy review at 380 events, and will seek to amend our Special Protocol Assessment (SPA) Agreement with the FDA accordingly. We are encouraged by what may be another opportunity for unblinding, assuming of course, FDA agreement.