Eagle Pharmaceuticals Inc. (NASDAQ:EGRX) Q1 2018 Earnings Conference Call - Final Transcript
May 10, 2018 • 08:30 am ET
then we'll let everybody know what the product was and we'll file it with the agency.
Okay, that's helpful. And then in terms of just -- if I may sneak in a follow up on RYANODEX. Has the FDA given you specifics on how many exposures, human exposures that it wants in EHS?
So, David, I would phrase it this way. Look, we all recognize that the difficulty of running a study like this is that you can't target a certain number of subjects because the Hajj is only four days. It comes to an end and you're done. We can only recruit what we can recruit. In this particular case, we've added a day to the beginning and we've expanded the time because it's so hot around the clock we're being told by the people who go the Hajj every year. The medical teams that we're working with is that you can get heat stroke patients later into the night. And so we've expanded to 12-hour days from eight-hour days. It would be -- in the perfect world we would wind up with a P value of 0.05 or better that would be the easiest way to quickest approval.
Our last study with only 34 patients was really strong. Our P value was at 0.08. And if you extrapolate out and when the statisticians do what they do, if we had somewhere between 70 and 100 patients, (inaudible) would have dropped down below 0.05. I think there's recognition at the agency as well that there's other really very positives in our data.
And so there's no real specific number. It would be great if we can get at least another 65 or so. Even if we round up with a number 35 and now we had two confirmatory studies with similar results, assuming that the results are similar, I think we have an excellent chance at approval. The key isn't so much around the numbers but the results. And if we wind up with a second study with similar response as we did the first time, I think we're in excellent shape and that's where the focus really should be. But if there's no stampede, if nothing happens this time, there's no reason to think that we shouldn't achieve more than enough subjects to make it extremely robust, add it to the first study and put us in a really strong chance of an approval and launch in the summer for next year.
Okay. Thank you.
Thank you. We'll go next to Randall Stanicky from RBC Capital Markets.
Great. Thanks. I have a few, Scott, let me just start with this though. How does the decision to launch big bag factor into the orphan exclusivity should you get it? I just find it interesting, the timing. The oral hearing was recently and the announcement or the intent to launch was announced today. So can you help us connect the two there?
Yeah, I think we can do