Friday, December 14, 2018 1:24:52 PM
[color=red]Both product candidates are currently in preclinical studies. The Company is hopeful to be in a position to file an Investigational New Drug application (“IND”) with the U.S. Food and Drug Administration (“FDA”) in the future. We expect to meet with the FDA during 2016 to determine the extent of any further required preclinical work prior to commencement of a clinical program.
New:
Mr. Dowling added, “Our drug development program is making steady progress in advancing our proprietary lead drug candidate - CVSI-007 - which addresses the multibillion dollar smokeless tobacco use and addiction market. We continue to make progress with our pre-clinical program, anticipating filing an Investigational New Drug application in 2019. We are confident that our continued growth and profitability will allow us to initially pursue our drug development plans without the need for additional outside capital in the near term. Given the industry’s robust growth momentum, we believe we have the right strategies in place and remain committed to achieve a strong 2018 finish.”
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