(1) In the above pipeline chart, “Development Path Decision” reflects the point in a program at which we decide whether to develop an AXA Candidate as a drug product candidate under an Investigational New Drug Application (IND), develop it as a non drug product candidate or terminate development. We have made a decision to develop AXA1665 as a drug product candidate and anticipate interacting with the U.S. Food and Drug Administration (FDA) again prior to submitting an IND. We have not made a development path decision for any of our other AXA Candidates. (2) We believe that this human clinical study under an IND (Clinical Trial) has the potential to serve as a registrational (pivotal) Clinical Trial, subject to continuing IND discussions and allowance by the FDA. Definitions: IRB = Institutional Review Board; NAFLD = non alcoholic fatty liver disease; OHE = overt hepatic encephalopathy; NASH = nonalcoholic steatohepatitis.
(1) In the above pipeline chart, “Development Path Decision” reflects the point in a program at which we decide whether to develop an AXA Candidate as a drug product candidate under an Investigational New Drug Application (IND), develop it as a non drug product candidate or terminate development. We have made a decision to develop AXA1665 as a drug product candidate and anticipate interacting with the U.S. Food and Drug Administration (FDA) again prior to submitting an IND. We have not made a development path decision for any of our other AXA Candidates. (2) We believe that this human clinical study under an IND (Clinical Trial) has the potential to serve as a registrational (pivotal) Clinical Trial, subject to continuing IND discussions and allowance by the FDA. Definitions: IRB = Institutional Review Board; NAFLD = non alcoholic fatty liver disease; OHE = overt hepatic encephalopathy; NASH = nonalcoholic steatohepatitis.