Ann: FDA grants Orphan Drug designation for Prader-Willi syndrome, page-23

Thanks, Hottod, we'll see what the FDA decides, then there's the DCCR of advanced Soleno Therapeutics, but it looks like FDA wants another study, who knows if after Levo changes his mind, by the way, Soleno has Vanderblit Partnership, which is the same one that Acadia made:

https://investors.soleno.life/news-...ics-announces-positive-data-showing-continued

Soleno will submit these data to the FDA as part of an ongoing discussion with the Agency regarding the clinical data necessary to support the submission of a New Drug Application (NDA) to market DCCR for the treatment of PWS. The FDA has previously conveyed to Soleno that another clinical trial will likely be needed and that open-label data and comparisons with natural history sources such as PATH for PWS may have statistical and other limitations, but it has agreed to review the data to determine whether it is appropriate for the Company to submit an NDA.

https://soleno.life/dccr/

https://soleno.life/clinical-trials/

https://investors.soleno.life/news-...erapeutics-announces-collaboration-vanderbilt

https://news.vanderbilt.edu/2020/06...atments-for-central-nervous-system-disorders/