NSPDF - Naturally Splendid Responds to Health Canada's Information Request Notice
(TheNewswire)
Vancouver, British Columbia - TheNewswire - October 16, 2020 - Naturally SplendidEnterprises Ltd. ("NaturallySplendid", "NSE" or "the Company")(FRANKFURT:50N) (TSXV:NSP) (OTC:NSPDF) has responded through theirjoint venture Plasm Pharmaceutical ("Plasm") to HealthCanada's Information Request Notice ("IRN").
The questions as posed by Health Canada are considered a formality asPlasm Pharmaceutical, continues to prepare for a phase 2 clinicaltrial for a potential Covid-19 treatment utilizing the target drugCavaltinib TM .
Biologic founder and Plasm Pharmaceutical lead researcherFranco Cavaleri states, " ThisCOVID crisis is not going to end anytime soon. Although a vaccine willbe the ultimate solution to the pandemic, we need alternative moreimmediate treatment strategies to reduce the degree of morbidity andrisk of mortality for those who are vulnerable today. In this regardwe have been in dialogue with Health Canada to develop a finalfunctional mutually acceptable phase 2 clinical trial for a COVIDtreatment, utilizing our Cavaltinib TM technology as the test drug. On October2, 2020, we responded to the latest Information Request Notice (IRN)from Health Canada. The IRN was designed to determine the final dosageof Cavaltinib TM intended for use as a COVID treatment and to define the final criteriafor the selection of patients making up the test and control groupsfor the trial. We have complied the last requests made by HealthCanada with regards to the experimental protocol and look forward to afinal reply from Health Canada on these matters."
In earlier news releases the Company has confirmed that it has securedlaboratory space, adequate supplies of Cavaltinib TM to conduct the30 day phase 2 clinical trial, as well as secured significantmanufacturing capacity in both Canada and the United States inanticipation of a positive outcome of the phase 2 clinical trial.
Previously, Naturally Splendid announced that HealthCanada had issued a No Objection Letter forCavaltinib TM , the target drug, in response to theClinical Trial Application as prepared by Biologic. The Company awaitsfurther direction from Health Canada.
We caution that this news release is not making anyexpress or implied claims that we have the ability to eliminate theCOVID-19 virus at this time. The scientific content of this newsrelease has been reviewed and approved by Biologic.
Plasm Pharmaceutical Joint VentureOverview
Plasm Pharmaceutical has been granted certain licenserights from Biologic patents as it relates to applications fortreating COVID-19 infections. The categories to be licensed willinclude, but are not be limited to, COVID-19 applications as well asadditional respiratory indications that may arise out of thefast-tracked clinical trial.
Naturally Splendid will own 16% of the joint venture aswell as be granted a 10% royalty on gross sales of all products andapplications arising from the clinical study. Biologic will own 82% ofthe joint venture with 2% assigned to key personnel within Biologic attheir discretion. Cavaltinib TM is an amplified variant of a currentBiologic patented technology, that taken in capsule form, wouldgreatly reduce or eliminate the need for virus infected patients tocongregate in hospitals or clinics for infusionsor other complex treatments. The resulting benefit of this type ofcapsule delivery mechanism, would make distribution of the treatmentfar more effective, at a fraction of the cost of treatment requiringhospitalization, which in turn could provide an extra layer of safetyfor front line medical staff.
For more information, please visit Plasm's website:www.plasmpharma.com
About Naturally Splendid EnterprisesLtd.
NSE operates a Safe Quality Food Level 2 certified food manufacturingfacility just outside Vancouver, BC in Canada. We have establishednumerous healthy, functional foods under recognized brands such asNatera Sport(TM), Natera Hemp Foods, CHII (TM), Elevate Me(TM) andWoods Wild Bar. The Company has a myriad of new products and lineextensions under development that are approaching launch. NSE has alsodeveloped proprietary technologies for the extraction of high demand,healthy omega 3 and 6 oils from hemp. NSE is the current"go-to" manufacturer for healthy, functional food productsand ingredients focusing on plant-based ingredients. The Companyprovides contract manufacturing services for many global healthy foodcompanies, private labelling a wide variety of nutritional foodproducts destined for global healthy food markets.
For more information e-mail info@naturallysplendid.com or call Investor Relations at 604-673-9573
On Behalf of the Board of Directors
Mr. J. Craig Goodwin
CEO, Director
Contact Information
Naturally Splendid Enterprises Ltd.
(NSP - TSX Venture; NSPDF - OTCQB; 50N -Frankfurt)
#108-19100 Airport Way
Pitt Meadows, BC, V3Y 0E2
Office: (604) 465-0548
Fax: (604) 465-1128
E-mail: info@naturallysplendid.com
Website: www.naturallysplendid.com
Forward-Looking Statements
Information set forth in this news release containsforward-looking statements that are based on assumptions as of thedate of this news release. These statements reflect management'scurrent estimates, beliefs, intentions and expectations. They are notguarantees of future performance. Naturally Splendid cautions that allforward looking statements are inherently uncertain and that actualperformance may be affected by a number of material factors, many ofwhich are beyond Naturally Splendid's control including, NaturallySplendid's ability to compete with large food and beverage companies;sales of any potential products developed will be profitable; sales ofshelled hemp seed will continue at existing rates or increase; theability to complete the sales of all bulk hemp seed purchase orders;and the risk that any of the potential applications may not receiveall required regulatory or legal approval. Accordingly, actual andfuture events, conditions and results may differmaterially from the estimates, beliefs, intentions and expectationsexpressed or implied in the forward-looking information. Except asrequired under applicable securities legislation, Naturally Splendidundertakes no obligation to publicly update or revise forward-lookinginformation.
NEITHER TSX VENTURE EXCHANGE NOR ITSREGULATION SERVICES PROVIDER (AS THAT TERM IS DEFINED IN THE POLICIESOF THE TSX VENTURE EXCHANGE) ACCEPTS RESPONSIBILITY FOR THE ADEQUACYOR ACCURACY OF THIS RELEASE.
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