CHARLOTTESVILLE, Va., June 28, 2022 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) (“Adial” or the “Company”), today issued the following letter to its shareholders from the Company’s CEO, William Stilley.
Dear Shareholders,
It continues to be my great honor to serve you as CEO of Adial Pharmaceuticals, especially at this momentous time when you and I, anxiously yet optimistically, await top-line results from the ONWARD™ Phase 3 clinical trial. Yesterday, we announced database lock for ONWARD, and today, I want to take this opportunity to personally write to you.
Great care was taken to verify and validate the integrity of all data collected during ONWARD, all of which remained blinded throughout. Now that database lock is complete, meaning the dataset has been permanently set, the data has been transferred to the Company´s outside, professional statisticians. At this point, only these statisticians have access to the unblinded ONWARD data, and they are now conducting their review.
When their analyses is complete, the statisticians will share the unblinded trial data and results with Adial. Adial will then review the unblinded data. In the next several weeks, and most likely by mid-July, we expect to publicly announce the top-line results. Following the announcement, Adial plans to further expand its review of the trial data to determine what other information may be useful to support an application for approval of AD04 to the FDA.
As Adial investors, we know the world needs a drug with the characteristics that AD04 demonstrated in the Phase 2b study. After more than three years of work and substantial investment, we seek to confirm and expand on the Phase 2b findings with revelation of the ONWARD results.
Nearly all of us have been impacted by alcohol addiction in some way. Precision medicine by genetic targeting could revolutionize the way addiction patients are perceived and treated. Adial is committed to advancing the science of addiction through medicine to achieve better outcomes.
Finally, thank you for your support. We could not have made it this far without you, and with you, we are advancing the battle against addiction.
Sincerely yours,
William Stilley, CEO