Neuren - Cracking the $200m m/cap again., page-82

Time to get back on topic.

As mentioned by Little T and also from the company releases, management are very excited about NNZ- 2591 given the strong pre-clinical results. We should have a response on the orphan drug applications recently submitted in the next 6-8 weeks. It also got me wondering if management would consider applying for a Breakthrough Therapy or Fast Track Designation at some point in time. The below FDA website link explains the FDA's various programs to expediate drug development and their criteria and differences:

https://www.fda.gov/regulatory-information/food-and-drug-administration-safety-and-innovation-act-fdasia/frequently-asked-questions-breakthrough-therapies

My understanding is the breakthrough therapy designation could be submitted anytime however no later than end of phase 2 meetings. The FDA responds within 60 days.