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Naturally Splendid Enterprises Ltd
Symbol NSP
Shares Issued 185,904,505
Close 2020-10-16 C$ 0.06
Market Cap C$ 11,154,270
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Naturally Splendid responds to Health Cda info request

2020-10-16 09:11 ET - News Release

Mr. Craig Goodwin reports

NATURALLY SPLENDID RESPONDS TO HEALTH CANADA'S INFORMATION REQUEST NOTICE

Naturally Splendid Enterprises Ltd. has responded, through its joint venture Plasm Pharmaceutical, to Health Canada's information request notice.

The questions as posed by Health Canada are considered a formality as Plasm Pharmaceutical continues to prepare for a phase 2 clinical trial for a potential COVID-19 treatment utilizing the target drug Cavaltinib.

Biologic founder and Plasm Pharmaceutical lead researcher Franco Cavaleri stated: "This COVID crisis is not going to end any time soon. Although a vaccine will be the ultimate solution to the pandemic, we need alternative more immediate treatment strategies to reduce the degree of morbidity and risk of mortality for those who are vulnerable today. In this regard, we have been in dialogue with Health Canada to develop a final functional mutually acceptable phase 2 clinical trial for a COVID treatment, utilizing our Cavaltinib technology as the test drug. On Oct. 2, 2020, we responded to the latest information request notice (IRN) from Health Canada. The IRN was designed to determine the final dosage of Cavaltinib intended for use as a COVID treatment and to define the final criteria for the selection of patients making up the test and control groups for the trial. We have complied the last requests made by Health Canada with regards to the experimental protocol and look forward to a final reply from Health Canada on these matters."

In earlier news releases, the company has confirmed that it has secured laboratory space, adequate supplies of Cavaltinib to conduct the 30-day phase 2 clinical trial, as well as secured significant manufacturing capacity in both Canada and the United States in anticipation of a positive outcome of the phase 2 clinical trial.

Previously, Naturally Splendid announced that Health Canada had issued a no-objection letter for Cavaltinib, the target drug, in response to the clinical trial application as prepared by Biologic. The company awaits further direction from Health Canada.

Naturally Splendid cautions that this news release is not making any express or implied claims that the company has the ability to eliminate the COVID-19 virus at this time. The scientific content of this news release has been reviewed and approved by Biologic.

Plasm Pharmaceutical joint venture overview

Plasm Pharmaceutical has been granted certain licence rights from Biologic patents as it relates to applications for treating COVID-19 infections. The categories to be licensed will include, but are not be limited to, COVID-19 applications as well as additional respiratory indications that may arise out of the fast-tracked clinical trial.

Naturally Splendid will own 16 per cent of the joint venture as well as be granted a 10-per-cent royalty on gross sales of all products and applications arising from the clinical study. Biologic will own 82 per cent of the joint venture, with 2 per cent assigned to key personnel within Biologic at its discretion. Cavaltinib is an amplified variant of a current Biologic patented technology that, taken in capsule form, would greatly reduce or eliminate the need for virus-infected patients to congregate in hospitals or clinics for infusions or other complex treatments. The resulting benefit of this type of capsule delivery mechanism would make distribution of the treatment far more effective at a fraction of the cost of treatment requiring hospitalization, which in turn could provide an extra layer of safety for front-line medical staff.

About Naturally Splendid Enterprises Ltd.

Naturally Splendid operates a food manufacturing facility (certified under Safe Quality Food Level 2) just outside Vancouver, B.C., Canada. The company has established numerous healthy, functional foods under recognized brands such as Natera Sport, Natera Hemp Foods, CHII, Elevate Me and Woods Wild Bar. The company has a myriad of new products and line extensions under development that are approaching launch. Naturally Splendid has also developed proprietary technologies for the extraction of high-demand, healthy omega-3 and omega-6 oils from hemp. Naturally Splendid is the current go-to manufacturer for healthy, functional food products and ingredients focusing on plant-based ingredients. The company provides contract manufacturing services for many global healthy food companies, private labelling a wide variety of nutritional food products destined for global healthy food markets.

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