Pediatric NASH Study

I'm super excited about the results from this study.  I believe, unlike Gemphire's gemcabene study in pediatric NASH which was terminated early due to safety concerns, ours will succeed.  Based on our NASH results last year, I believe we will absolutely hit the primary endpoint here, which is percent change in ALT level.  What's more, because of our drug's safety, I think the FDA would be a huge proponent of seeing IMM-124E approved for children with NASH.  And check this out, unlike with adult patients, the FDA is very open to a range of possible primary endpoints in children with NASH:

https://www.raps.org/news-and-articles/news-articles/2018/12/fda-issues-draft-guidance-on-nash-drug-development

"For NASH treatments granted accelerated approval on the basis of liver histology, FDA says that randomized, double-blind, placebo-controlled trials to verify clinical benefits should be underway when the marketing application is submitted. The guidance also provides some caveats for pediatric development, as “Pediatric NASH appears to have different histological characteristics as well as a different natural history when compared to adult NASH. For reasons that are currently unknown, disease characteristics and progression in pediatric patients may be different.” As such, FDA says that extrapolation of efficacy from adults “is not appropriate at this time,” and that longitudinal natural history data for pediatric patients are needed. FDA says it plans to further address issues related to pediatric noncirrhotic NASH in an upcoming guidance."

Anyone have any idea how enrollment is progressing here?  Topline data according to IMC is expected 2nd quarter 2019.

Finally, did anyone else know that the presitigious med tech company Advanced MR Analytics AB is collaborating with us in the pediatric NASH study?

https://clinicaltrials.gov/ct2/show/NCT03042767?cond=pediatric+nash&rank=3