Are they serious going into a Phase 2 trial with this data?
How can they go into a larger Phase 2 with this totally inconsistent data? Sorry NBIX, you need to do the trial over. This is a mess. Also, who the heck is in charge of organizing your trials? Pathetic. Thank God Abbott is running the Phase 3's in endometriosis. This was a mess.
I have been a huge NBIX supporter but come on everyone.
37 patients....3 trial sites. It doesn't work if you include all three sites because of the mess-up so you remove one site.
12.5mg doesn't work and also there isn't much statistical difference between the data set that keeps the bad site and the data site that gets rid of it. There were 17 patients in the 12.5 mg group.
Drawing statistical meaning from 15 patients in the 50mg group is basically impossible and you're removing a site to make it happen so it's like looking at 10 patients!. On top of this, the 12.5mg dose actually performed worse after you removed the other site! You could say the extra site made the drug more effective for 12.5mg's. Saying it's more effective without the extra site at 50 mg's is just as silly. You're also seeing akathisia at 50 mg's which is basically very uncomfortable movements that are impossible to suppress. Not good for a patient population that already suffers from uncontrolled movements.
Honestly speaking, this sounds like a mess to me. There is no need to spend a ton of money in a large Phase II for something that already has super flawed data. Do another study and actually prove that this works before spending time and tons of money on something that is inconclusive at best.
I honestly cannot believe this company would issue a press release based on roughly 10 patients in a 50 mg dose cohort (out of 37 total) to state that a drug works and justifies huge spending. Unreal and not acceptable.
>>On top of this, the 12.5mg dose actually performed worse after you removed the other site! You could say the extra site made the drug more effective for 12.5mg's. Saying it's more effective without the extra site at 50 mg's is just as silly. <<
I think you looked at the results wrong here, not what I see them saying
The total number of sites is actually 8. So removing one site from 8 sites due to "measurement error" (especially with clear discrepancy between AIMS score and video recording) may not be a major concern. It is better to find such measurement "error" in phase II instead of phase III.