Nah. It's 50 patientsI hear ya, CDiddy. And you a
Post# of 148292
Quote:I hear ya, CDiddy. And you and I (and others) have broached this exact topic several times now.
Nah. It's 50 patients
So, you can imagine how surprised I was to hear this very different characterization from NP.
Here is the audio clip:
https://clyp.it/k0je2rm5
What I am hearing is that the interim results from the P2-3 can provided to the FDA at 50% (of enrollment) -- so the plan is to hopefully hit the primary endpoint of the P2, and then ask the FDA to do the interim analysis of the P2-3 for expanded label.
This explanation is even more curious in the context of my belief that the 50-patient interim results of the P2-3 will likely precede the P2 results.
I welcome any and all feedback that will get me to a definitive understanding of how exactly this will unfold.