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Ampio announced the receipt of written "Negative" responses from the FDA pursuant to a Type C meeting request submitted by the Company regarding the AP-013 trial results.
On May 16, 2022, Company announced that an independent special committee of the Ampio Board of Directors, with the assistance of independent legal counsel, is in the process of conducting an internal investigation that relates to, among other matters, Ampio's AP-013 clinical trial and other clinical trials.
On August 03, 2022, Company issued a letter to Shareholders covering the initial results of the investigation. Special Committee's primary findings include that certain former Ampio executive officers and senior staff were aware, at the time of the per-protocol interim analysis in March 2020, that the AP-013 trial did not demonstrate efficacy for Ampion on its co-primary endpoints of pain and function; and that these former Ampio executive officers and senior staff did not fully report the results of the AP-013 trial and the timing of unblinding of data from the AP-013 trial.
Failure to Disclose,
Shock Event Date
20 April 2022