Incannex Appoints FDA Regulatory Affairs Expert Mr Robert B. Clark to the Board of Directors

Incannex Healthcare (ASX: IHL, NASDAQ: IXHL) announced the appointment of Mr Robert B. Clark to the board of directors of the company. Robert Clark is a US based, internationally recognised expert on US FDA (Food & Drug Administration) / EMA (European Medicines Agency) liaison interactions. He is a highly experienced pharmaceutical executive with more than 20 years at Pfizer and 10 years plus at Novo Nordisk. He is also a nationally recognized expert on US pharmaceutical advertising and promotional activity. During his time at Pfizer and Novo Nordisk, Robert secured FDA registration and marketing approval for 12 significant new drugs. He also has documented success with the FDA accelerated approval program including Fast-Track Designation, Orphan Drug Status, Breakthrough Therapy Designations and Priority Reviews.

Robert is currently Vice President, US Regulatory Affairs for Novo Nordisk, where he provides strategic leadership to a team of over 50 regulatory staff and scientists in the development of new medicines, a team which manages all interactions with the FDA on behalf of Novo Nordisk. Robert also advises the global executive team about drug development programs, FDA liaison strategies and managing FDA compliance issues. He is amongst the most experienced and knowledgeable experts in the world when it comes to regulatory affairs.

Securing an executive of Mr Clark’s calibre is a real coup for Incannex and Canary Capital believes he will play a key role in progressing Incannex’s drugs through the approval process in the United States and other key markets such as the EU. Importantly, the company plans to run the phase 2 trial of IHL-42X for the treatment of obstructive sleep apnoea in the US because it is expected that this is likely to speed up the approval by the FDA because the trial will be specifically designed to meet their protocols.