An important note missing in the article, the FDA approved this with the Fast Track designation [1].
I'm still looking for the safety and efficacy study done. I also haven't yet found the justification for fast tracking this. An alternative to an epipen injection seems reasonable, but why rush it through when we already have the epipen?
I'm still looking for the safety and efficacy study done. I also haven't yet found the justification for fast tracking this. An alternative to an epipen injection seems reasonable, but why rush it through when we already have the epipen?
[1] https://www.fda.gov/news-events/press-announcements/fda-appr...