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Naturally Splendid Enterprises says Health Canada wants more information on its Phase 2 coronavirus trial

Health Canada has requested specific protocol details regarding the trial of the drug from the proposed joint venture with Biologic Pharmaceutical Research

Naturally Splendid Enterprises Ltd. -
Many countries are still reporting a rise in coronavirus cases and a growing number of deaths

Naturally Splendid Enterprises Ltd (CVE:NSP) (OTCMKTS:NSPDF) has updated on its clinical trial plans for Cavaltinib to treat coronavirus (COVID-19), saying that Health Canada had requested further details of the phase 2 study.

On July 29 this year, the plant-based food and ingredients group, said it had received a 'No Objection' Letter, which acknowledged drug candidacy and the authority to proceed.

READ: Naturally Splendid says Health Canada approved Phase 2 clinical trial of Cavaltinib to treat COVID-19

Now, Health Canada has requested specific protocol details regarding the trial of the drug from the proposed joint venture with Biologic Pharmaceutical Research, before it can begin, Naturally Splendid told investors in a statement.

The requested content has been submitted and once that receives approval from Health Canada, the company will update the timing for the start date of the anticipated 30-day trial.

"We are fortunate to be operating in a country with such a robust healthcare system that is still agile enough to move swiftly to serve and protect its citizens," said Franco Cavaleri, lead researcher.

"We are excited to be working with the Health Directorate of Health Canada to fine-tune the trial details to meet regulatory parameters and in more general terms to be given the opportunity to contribute to community, the nation and hopefully beyond that to countries needing the support we may be able to offer."

The need for treatment for COVID-19 remains critical as the pandemic continues to inflict health and economic damage across the globe with many countries still reporting a rise in cases and a growing number of fatalities, the firm added.

One of the key advantages of Cavaltinib is that it can be delivered via capsule, significantly reducing the strain on healthcare facilities and there is no need for long-lasting stays in hospitals or clinics.

The drug has been shown to inhibit small proteins released by cells called cytokines that are central to the “cytokine storm” phenomenon, where the body starts to attack its own cells rather than just fighting off the virus as seen in critically ill coronavirus patients.

Shares slipped around 7% in Toronto on the day to C$0.065.

Contact the author at giles@proactiveinvestors.com

Quick facts: Naturally Splendid Enterprises Ltd.

Price: 0.06 CAD

Market: TSX-V
Market Cap: $11.06 m

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