The primary endpoint for the Phase III trial was met in the Phase 2b trial. The mean change in Hgb was .639 in the Phase 2B trial and it only needs to be greater than .5 in the Phase III trials to show effectiveness. There was a .177 drop in Hgb for the placebo side and a .462 gain in Hgb on the SFP side.
The Phase 2B trial was very short so people in the placebo side did not use up their stored iron so the Hgb drop was small. Because of the Prime study data we can expect that data from the Phase III trials (being a much longer study than the Phase 2B trial) will show a much greater drop in Hgb on the placebo. Remember in the Prime study ESA’S had to be increased 35% to keep Hgb the same in the placebo group. Now in the Phase III trials ESA’s will be kept the same so the drop in Hgb should be much greater than the Phase 2B trial. Remember the phase 2B trial showed effectiveness and the phase III should be significantly better.
Phase III trial designed to succeed! All the talk about Phase IIb is misguided, misplaced and noise. Anyone who understands SFP and specifically the design of Phase III, is feeling good and very confident holding into CRUISE results in July. No worries at all...
Sentiment: Strong Buy
Sorry for the confusion i've re read now.. However isn't your statement false? Primary endpoint for the P3 trial is decrease by 1.0 or more correct? So .639 is still a failure.. you're just doubling it since it's a 12 month instead of 6 month study? Doesn't work like that
Google "Rockwell" and "Katie McQue" and read the first link that pops up (since I can't post it here), focusing on the section titled Phase III. Postive Phase III results are a lock. have 16K share position, btw, as of today and have zero concerns. You think the investor that just put up $40M to purchase the secondary is half as concerned as the nervous longs sweating their tiny positions. what a joke. relax, or sell and move on.
I thought the primary endpoint was not met, but possibly due to the fact that the placebo changed their dosages and the trial was so short.. isn't it supposed to have a decrease by 1.0 or more?