Naturally Splendid Enterprises Ltd (CVE:NSP) (OTCMKTS:NSPDF) (FRA:50N), which is developing a coronavirus (COVID-19) treatment through a joint venture with Biologic Pharmamedical Research, responded to an information request notice from Health Canada, the company announced Friday.
The joint venture, Plasm Pharmaceutical, is preparing for a phase 2 coronavirus trial of its drug cavaltinib, and the questions from Health Canada are considered a formality, the company said.
"This COVID crisis is not going to end anytime soon,” Biologic founder and Plasm Pharmaceutical lead researcher Franco Cavaleri said in a statement. “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.”
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The lingering questions for Plasm concern the dosage of cavaltinib to be administered during the trial.
“On October 2, 2020, we responded to the latest information request notice (IRN) from Health Canada,” Cavaleri said. “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 [with] 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."
The company previously announced that it secured the necessary lab space and supply of cavaltinib to conduct the trial, in addition to significant manufacturing capacity in Canada and the US, should things go to plan.
Health Canada previously issued what is called a 'no objection' letter for cavaltinib, in response to Biologic’s clinical trial application for the drug.
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