I have studied DME trial data from Genentech, REGN, Allegro, Ozurdex (Allergan), and many others. Never have any of these referred to BMI. Never have seen data reported in this way before. This looks totally cherry picked.
Just give them time to get on their feet and time to analyze the data as it must be. In research studies, things are not as easy as they look.
Only AMPE seems to feel that BMI is an important criterion for efficacy.
This report seems suspiciously like cherry picking.
They reported on 106 of 359 patients in the trial.
I agree that success with a subgroup could be important but what common characteristics does this subgroup have?
Do they all have the same complement factor -- which can be key?
Need much more information.
"I think we need a fuller report on the data."
I think you're right.
106 eyes is 53 people if both eyes were affected. Given management's history of massaging released data and FDA's aversion to data mining( based on BMI? body mass index?) I think this is going to be an opportunity to further disappoint shareholders.
"Furthermore, we successfully identified a subgroup of patients based on BMI (n= 106 eyes) in which treatment with the optimal Optina dose resulted in significant improvements in both vision and retinal swelling."
They only need a sub group of people this works on to be sucessful. Now they can go to FDA and finalyze a trial that works for the people it should work on. The previous group the FDA requested was too big now they have what they need to produce a drug for the right people. And expensive drug that is.
So they found 106 people who did the best and that's who they reported on.
How many TOTAL people were in the study and why didn't they report overall numbers?
I think we need a fuller report on the data.
this subset of people could amount to a big $ drug.
Furthermore, we successfully identified a subgroup of patients based on BMI (n= 106 eyes) in which treatment with the optimal Optina dose resulted in significant improvements in both vision and retinal swelling.