Wow great article, spot on. One thing that could be improved though is you mentioned how the FDA will overlook the statistical insignificancies, as they have In the past. The FDA, if you do some research, explicitly stated that illuvien is not required to meet statistical significance through weeks 24-36.
Furthermore, Alimera has stated the manufacturing issues were resolved and inspections were completed.
Thanks for the info. You're right, I hadn't seen the FDA comments, so I should mention that the 36 month data does not change the 24 month primary efficacy endpoint of the study. I also didn't know Alimera had definitively resolved the manufacturing issues; I just assumed they had because they resubmitted the NDA, so that's good to hear.