Friday, June 22, 2018 1:48:00 PM
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.
Recent RNGE News
- Form 8-K - Current report • Edgar (US Regulatory) • 06/20/2024 01:15:36 PM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 05/16/2024 01:36:56 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/15/2024 09:12:25 PM
- Form S-1 - General form for registration of securities under the Securities Act of 1933 • Edgar (US Regulatory) • 05/08/2024 06:54:30 PM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM
Dear Cashmere Group Holding Co. AKA Swifty Global Signs Binding Letter of Intent to be Acquired by Signing Day Sports • DRCR • Sep 19, 2024 10:26 AM
HealthLynked Launches Virtual Urgent Care Through Partnership with Lyric Health. • HLYK • Sep 19, 2024 8:00 AM
Element79 Gold Corp. Appoints Kevin Arias as Advisor to the Board of Directors, Strengthening Strategic Leadership • ELMGF • Sep 18, 2024 10:29 AM
Mawson Finland Limited Further Expands the Known Mineralized Zones at Rajapalot: Palokas step-out drills 7 metres @ 9.1 g/t gold & 706 ppm cobalt • MFL • Sep 17, 2024 9:02 AM
PickleJar Announces Integration With OptCulture to Deliver Holistic Fan Experiences at Venue Point of Sale • PKLE • Sep 17, 2024 8:00 AM