Nektar Therapeutics (NASDAQ:NKTR) Q4 2015 Earnings Conference Call - Final Transcript
Mar 01, 2016 • 05:00 pm ET
Thank you. [Operator Instructions] Our first question comes from the line of Jonathan Aschoff with Brean Capital. Your line is open. Please go ahead.
Thanks. I'm a little bit confused about something guys. I was wondering why would you not have increased the trial size -- the 181 trial size if the powering was below 50%? I mean, wouldn't that have been low and bad? Could you help me understand that a little better?
Yeah, Jonathan, look, that's a good question. I think there's no right or wrong answer to, sort of, where you, sort of, decide to increase the power. But I think we picked 50% to 85% because our feeling was that, that was a good range, and we would be able to increase, not increase -- you would really have to put very large numbers into the trial if it was below 50%. And we didn't -- we felt that if it was below 50% power -- and of course it can be anywhere from 50% to 85% power, 50% is the low range, we'd like to hope we're close to the 85%, but anywhere within there, you're going to make a meaningful difference by adding 200 patients to the study.
You're going to, sort of, increase the likelihood of demonstrating statistical significance between the active agent and placebo. Our feeling was that going well below 50%, we'd have to put many, many more patients in, and we didn't feel it was worth the investment.
Okay. But if it was below 50%, you would have stopped the trial is what I'm reading from that, yet you said the only two outcomes were to add or not add patients. So, that's why I am confused.
Yeah, yeah. Sorry. Let me explain that. There are only two outcomes. So, the outcomes are, between 50% and 85%, we'd increase the number of patients. However, if it was below 50% or 85%, we would do nothing. However, we would not have known whether we hadn't added patients, because it was above 85% or because it was below 50%. So, giving us more -- we obviously didn't want to take an alpha hit, and we didn't -- and there was no unblinding. So, we preset these criteria. We know nothing else about this study, other than the fact -- we would have known nothing else other than the fact that it was between 50% and 85%, or essentially it wasn't between 50% and 85%. If it wasn't between 50% and 85%, we would have done nothing. We now know that it was between 50% and 85%, so clearly we added 200 patients. Does that help?
Okay. So, do you know which arm is outperforming which arm?
Do we know which arm is outperforming which arm? You mean the Type 2, but the statistical analysis would indicate -- the way that this -- we designed this, you have to be clear that the active arm would be outperforming the placebo arm.
You said it