Range Impact Inc (RNGE)

[236T568]

FDA DENIES VBIO's request for orphan drug designation


https://ih.advfn.com/p.php?pid=nmona&article=76988662&symbol=VBIO


Letter from the FDA’s Office of Orphan Products Development

In a letter received March 15, 2018, from the U.S. Food and Drug Administration’s (“FDA’s”) Office of Orphan Products Development (“OOPD”), attached hereto as Exhibit 20.1, the OOPD informed the Company that its request for orphan drug designation was unable to be granted based on the Company’s existing submission. The FDA recently announced that it no longer intends to grant orphan drug designation to drugs for pediatric subpopulations of common diseases and also cited within its letter to the Company (the “OOPD Letter”) clinical data published in 2017 that suggests the overall prevalence in the United States of ulcerative colitis and pediatric ulcerative colitis may exceed 200,000, which is the upper limit to be considered an orphan condition. Although the company possesses additional preclinical and clinical data on use of cannabinoids and its drug products for treatment of colitis, which the Company expects could fulfill the OOPD’s separate requests for additional scientific data, the Company does not intend to further pursue orphan designation for treatment of this disease given recent FDA policy changes and the updated clinical data that suggests a high prevalence of ulcerative colitis and pediatric ulcerative colitis in the United States.