Let me summarize, why I think Tdox has a 20+ month median pfs. We know that it took aprx. 30 months for 380 events to occur after 380 patients were enrolled. We know that 320 patients were enrolled after the first 380. We know that some of the 320 contributed to the 380 events, so it follows that the actual time for the first 380 patients to event is substantially more than 30 months...at least 33 months, probably 40+ months, but lets just say 36 months. So, if it took 3 years for all 380 patients to event, what is likely to be the MEDIAN pfs of the overall trial at that point?...3 months NO, 36 months NO, 12 months NO, 30 months NO, between 15-25 months PROBABLY. Lets say 20 months in our conservative exercise. Thus, if the company's projection of a 12 month median placebo pfs is true, then Tdox must be at 28 months...if placebo is 15 then Tdox is 25 (ala Biopharm's prediction). Even if RFA only is 17 months we likely still succeed with a 23 Tdox pfs. But if company is way off and placebo is doing 18+ months than we likely fail. What excites me, however, is that the time lag between x enrollment and x events is increasing drastically (from 22 to 30 months). Given the increase in enrollment rate from 219 to 380 patients, this is probably due to Tdox outperforming placebo. Thus, 20 v. 21 or similar is probably not occuring.
My only concern is that taking only the first 380 eventees into consideration, and discounting the remaining (majority Tdox) patients who haven't evented will unnecessarily skew the trial towards failure. Since placebo and Tdox enrollment rates were on equal footing, I really wish they consider the current pfs periods of the non-eventing patients as well; that way all of those "cured," e.g., 30+ month free and clear Tdox patients will be counted. To exclude them, makes no sense and would be a travesty. That's like giving up on a close election before your favorable late arriving precincts are counted. If they will truly tabulate only eventees, then we could see the case where we fail at 380 events but easily succeed after 700 events.
Sentiment: Strong Buy
There would be no concern if most of the eventees were on the control arm.
And the remaining of the Tdox arm are mostly in the 320.
300 patients who evented were on RFA alone.
80 patients who evented were on RFA+Tdox.
Would not this scenerio favor Tdox arm with at least 33% improvement?
seeking alpha article also mentioned the "missing 321 patients" (701-380) and their status. so why did they increase the trial size and at first gance that looks to be positive? real good analysis by you and another poster i just read; lots of good discussion here; much appreciated
Sentiment: Strong Buy