Not sure if this has been posted here. This is fro

Not sure if this has been posted here. This is from Jesus, on YMB:

Chris Recknor mentioned we are working with Dunn Regulatory:

“ Our expert consultants are US and EU strategists, who have a proven track record of resolving even the most complex regulatory situations. We can:

-Develop pragmatic approaches to regulatory challenges
-Develop concise and thorough regulatory strategies
-Lead regulatory meetings and meeting package preparation
-Resolve complex pharmacology/toxicology, clinical or CMC regulatory issues
-Write, manage, and review all modules of the common technical document (eCTD) from IND to BLA or NDA
Negotiate with the FDA and EMA
-Strategically determine product placement
-Serve as your US Agent
Leverage expedited regulatory pathways
-Prepare Integrated Development Plans
Prepare Orphan Drug, Breakthrough Therapy, and Fast Track applications
-Perform Due Diligence
-Electronic Publishing Services (through the ESG)

Different statistical groups and neurological reporting

In result:

“We are discovering things about this molecule that weren’t discovered previously.” -Scott Kelly