“FDA’s Fast Track designation will enable an expedited regulatory review process for our proprietary formulation of CBD in the treatment of pediatric patients with Prader-Willi syndrome, a debilitating condition which currently does not have any approved products available,” said
The most common known genetic cause of life-threatening obesity in children, Prader-Willi syndrome has a prevalence of approximately 1 in 15,000, according to the
“We are very encouraged by the FDA’s decision to put CBD for Prader-Willi on the Fast Track and believe it is good news for these young patients, their families and clinicians,” said
This news release contains forward-looking statements including regarding (i) our belief that FDA’s Fast Track designation will enable an expedited regulatory review process for our proprietary formulation of CBD in the treatment of pediatric patients with Prader-Willi syndrome, (ii) our belief that Prader-Willi syndrome currently does not have any approved products available and that our proprietary CBD formulation has potential to be a viable treatment option and (iii) our plan to start the clinical development program for this promising therapy in late first quarter of 2018. These forward-looking statements are based on management’s expectations and assumptions as of the date of this news release; actual results may differ materially from those in these forward-looking statements as a result of various factors, many of which are beyond our control. These factors include, but are not limited to, risk factors described in our filings with the United States Securities and Exchange Commission, including those factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended Dec. 31, 2016 and subsequent updates that may occur in our Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date of this news release, and we undertake no obligation to publicly update or revise these statements, except as may be required by law.
Alpha IR Group