$heff's $tation of $tocks & $olid DD

[gambler2075]

$SPHS Here is why I think the P3 will succeed.
I believe they just need to reach statistical significance, rather than the arbitrary 2.0 IPSS point difference that the admin interim analysis tried to reach.

Most SPHS bears seem to believe that the Triumph (phase 2) trial was not significant at 12 months, and further, the 12 month data was worse than at 3 months. Both of these points are true. As a result, they assume that the Phase 3 (PLUS-1) trial will almost certainly fail, as the 3 month interim data failed, and the 12 month data in the P2 was worse than the 3 month data in P2, so if the 12 month PLUS-1 data is worse than the 3 month PLUS-1 data, and the 3 month interim failed, then the 12 month is certainly going to fail.

Right?

Well, here is why I think that line of reasoning is faulty.

I believe that the primary endpoint of the Phase 3 trial is actually statistical significance, and NOT the same as the admin interim analysis.

Here's a screenshot of my DD and thoughts on that topic:

http://www.bilderload.com/daten/plus1endptRT2B0.jpg

GLTA. DYODD.
g