VITALITY BIOPHARMA, INC (OTCMKTS:VBIO) Files An 8-K Other Events

VITALITY BIOPHARMA, INC (OTCMKTS:VBIO) Files An 8-K Other Events
Item 8.01 Other Events.

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Management Letter to Shareholders

On March 16, 2018, the Company’s CEO sent a letter, attached hereto as Exhibit 19.1, to all shareholders of record, which described the Company’s current research and development efforts (the “Shareholder Letter”). In addition, the Company issued a press release, attached hereto as Exhibit 19.2 (the “Press Release”), which described the Shareholder Letter and included a link to the Shareholder Letter on the Company’s web site.

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.

The foregoing descriptions of the Shareholder Letter and the OOPD Letter do not purport to be complete and are qualified in their entirety by reference to the full text of each document. Copies of the Shareholder Letter and the OOPD Letter are attached to this Current Report on Form 8-K as Exhibit 19.1 and Exhibit 20.1, respectively, and each is incorporated herein by reference.

The information set forth under Item 8.01 of this Current Report on Form 8-K is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, and shall not be deemed incorporated by reference in any filing with the Securities and Exchange Commission under the Securities Exchange Act of 1934 or the Securities Act of 1933, whether made before or after the date hereof and irrespective of any general incorporation by reference language in any filing.

Portions of this report constitute “forward-looking statements” defined by federal law. Although the Company believes any such statements are based on reasonable assumptions, there is no assurance that the actual outcomes will not be materially different. Any such statements are made in reliance on the “safe harbor” protections provided under the Private Securities Litigation Reform Act of 1995. Additional information about issues that could lead to material changes in the Company’s performance is contained in the Company’s filings with the Securities and Exchange Commission and may be accessed at www.sec.gov.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.


Vitality Biopharma, Inc. Exhibit
EX-19.1 2 ex19-1.htm   Exhibit 19.1        To the Shareholders of Vitality Biopharma,…
To view the full exhibit click here

About VITALITY BIOPHARMA, INC (OTCMKTS:VBIO)

Vitality Biopharma, Inc., formerly Stevia First Corp., is engaged in the development of cannabinoid prodrug pharmaceuticals. The Company unlocks the power of cannabinoids for the treatment of serious neurological and inflammatory disorders. Its product pipeline includes cannabosides, VITA-100 and VITA-210. Cannabosides are cannabinoid glycoside prodrugs. VITA-100 is an oral cannabinoid formulation containing cannabosides that is being developed for treatment of inflammatory bowel disease, epilepsy, schizophrenia, and other disorders. VITA-210 is a cannabinoid glycoside prodrug being developed primarily for treatment of pain and muscle spasticity in multiple sclerosis and in rare white matter disorders. The Company’s facilities include laboratories and a manufacturing suite for good manufacturing practices (GMPs) production, which will be used for pharmaceutical-grade production of products to be tested in clinical trials.

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