Gotta see it from our side. we got this quiet little board and all of a sudden PPS goes up a few cents and we get buried with a bunch of know-it-alls who think they're smokin us.
Goldie lox, for example, got here when you did. Why are you asking her anything??? Notice how she popped right back atch'ya with the answer to your question?! LMAO.
tleaf is alright. if anyone is considered the A-hole around here its probably me... lol
Look, orBec was purchased as a pipeline product back in around '03. At the time of purchase it was already in its PIII. So the 50 day mark had been designed into the trial by whoever designed the trial. At the end of the PIII which was toward the end of 2004, the data showed that statistical signifcance had not been achieved at day 50. This had less to due with efficacy and more to do with poor design as a strong dosage of prednisone was given to patients for approx. the first 10 days of the trial. That jolt skewed the numbers on the orBec data at day 50 and significance was missed. At the secondary endpoint of 80 days, everything was cool and statisical significance was achieved. OK, what now? The company decided to proceed with applications for the US and EU anyway. The review panel here shot orBec down due to the missed primary and the FDA foillowed suit. The company put a plan together with the fed who agreed to accept significance at day 80, now, as the new primary rather than secondary endpoint. Juicy (although this company does have a way of F'ng things up). So that's what's happening and that's where we're at. If statistical significance can be duplicated a second time at day 80, Europe will also approve.
Got it now?
Read the section discussing orBec near the beginning of the quarterly released in Nov. That'd be for PE 8/31/09. Read it twice. It'll take 10 minutes and then you'll have it.
Does Schaber's lackluster (to be nice) history with Discovery concern you? He spent just over 8 years there. "Dr. Schaber served from 1998 to 2006 as Executive Vice President and Chief Operating Officer of Discovery Laboratories, Inc., where he was responsible for overall pipeline development and key areas of commercial operations, including regulatory affairs, quality control and assurance, manufacturing and distribution, preclinical and clinical research, and medical affairs, as well as coordination of commercial launch preparation activities"
Also, why was prednisone part of the last trial? Are you saying that once the dose wore off, the Orbec kicked in at day 80? Lastly, as a newbie here, why would the panel choose to focus on day 50 versus day 80? Certainly the farther one goes out, the more meaningful the efficacy? thanks again.