- PPP had filed a RFD for PPP001 to be classified as a drug and assigned to the Center for Drug Evaluation and Research
- RFD enables the FDA to determine the product type and appropriate lead center.
OTTAWA, ONTARIO–(Sept. 26, 2016) - PhytoPain Pharma (“PPP“), a subsidiary of GrowPros Cannabis Ventures Inc. (“GrowPros” or the “Company” or “GCI“) (CSE:GCI), a pharmaceutical company focused on developing and commercializing therapeutic cannabis-based products for the treatment of pain and other medical conditions, received an Acknowledgement Letter from the U.S. Food and Drug Administration (“FDA“) after submitting a Request for Designation (“RFD“). PPP had filed a RFD for PPP001 to be classified as a drug and assigned to the Center for Drug Evaluation and Research (“CDER“). The RFD enables the FDA to determine the product type and appropriate lead center. If the FDA has not issued a designation letter within 60 calendar days of the filing of the RFD, PPP’s recommendation will become the designated classification and assignment.
According to Dr. G. Chamberland, Chief Scientific Officer, the RFD was submitted to establish the lead review for the PPP001-kit. He stated, “PPP recommended that the product PPP001-kit (PPP001 drug component and PPP-titanium pipe device component) be regulated as a Combination Product and that based on the Primary Mode of Action (PMOA) that primary jurisdiction be granted to CDER.” Dr. Chamberland further commented that this regulatory filing is part of PPP’s dedication to the commercialization of marijuana as a prescription controlled drug and the corporation’s plan to seek reimbursement by insurers for patients.
About PPP001-kit product
PPP001-kit product will be prescribed by physicians and available in pharmacies as two separate products packaged together in a single package and is comprised of the prescription controlled drug PPP001 (dried standardized cannabis sativa in a blister pack) and the fully assembled device PPP001-titanium pipe. The titanium pipe will be used to generate the smoke by combustion to deliver the active ingredients via inhalation. The drug component and device component will be linked together by the labelling of each component. Each blister of PPP001 drug pellet contains cannabis sativa with a standardized amount of delta-9-tetrahydrocannibinol. A single PPP001 drug pellet is pushed out of the blister by the patient and inserted into the PPP-titanium pipe for combustion and inhalation of the smoke.
“An RFD is also referred to as an applicant’s letter of request to the FDA (see 21 Code of Federal Regulations (“CFR”) 3.2(j)). It is a written submission to the Office of Combination Products (“OCP”). RFDs generally request a determination of (1) the regulatory identity or classification of a product as a drug, device, biological product, or combination product, and/or (2) either the component of FDA that will regulate the product if it is a non-combination product, or which Agency Center will have primary jurisdiction for premarket review and regulation if it is a combination product. A letter of designation, see 21 CFR 3.2(i), (alternatively referred to as a designation letter) is FDA’s formal response to an RFD and is a binding determination with respect to classification and/or center assignment that may be changed under conditions specified in Section 563 of the FD&C Act and 21 CFR 3.9 in the regulations.” For further information regarding the RFD process, please visit the FDA website, www.fda.gov. Text was taken from FDA’s Guidance for Industry – How to write a Request for Designation (RFD).
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Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words “may”, “will”, “should”, “continue”, “expect”, “anticipate”, “estimate”, “believe”, “intend”, “plan” or “project” or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company’s ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company, through its wholly-owned subsidiary, GrowPros MMP Inc., to obtain a licence for the production of medical marijuana; failure to obtain sufficient financing to execute the Company’s business plan; competition; regulation and anticipated and unanticipated costs and delays, and other risks disclosed in the Company’s public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.