Thanks for your comments Billy.
Not disputing that they will have various paths available to get to market faster with fast track, orphan and potentially Breakthrough therapy. Agree on that with you. However I am convinced that this is a small molecule class drug and not a biologic drug.
It is produced by chemical synthesis. see this http://nzic.org.nz/CiNZ/articles/CiNZ Jul 2011_brimble.pdf
https://neurogram.wordpress.com/2014/11/11/neurens-phase-ii-success-in-rett-syndrome/
http://adisinsight.springer.com/drugs/21885
http://www.**ionline.net/Biosimilars/Research/Small-molecule-versus-biological-drugs
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