Tuesday, January 31, 2017 8:05:08 AM
The Company will lock its database after 30-day follow-up from the final patient, and currently expects to report top-line results in January 2017 in conjunction with the study’s lead investigators at Duke Clinical Research Institute (DCRI).
“We are very pleased to reach this milestone after more than two years of hard work, and would like to thank all of the patients and investigators who have taken part in the trial,” said John Kelley, CEO of Tenax Therapeutics. “Consistent clinical execution and increased trial visibility has significantly accelerated the enrollment rate during these past 12 months, and we believe the expanded number of patients ensures that we have the best possible chance for success. We now look forward to sharing top-line results with you during the next few months, and we are prepared for a near-term NDA submission and commercial effort if the data reads out positively. We continue to believe that levosimendan has the potential to fill an important void in the current treatment paradigm for cardiac surgery.”
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