Medical cannabis device developer Lifespot Health (ASX: LSH) has announced a revised research and development strategy prioritising US Food and Drug Administration (FDA) approval of its Medihale cannabinoid inhaler system.
The news follows several changes to the company’s board including the most recent appointment of a new chairman, Sean Williams.
Lifespot today revealed its chosen regulatory pathway in its June quarterly update, stating its belief that the FDA will provide a faster timeline to registration than Australia’s Therapeutics Goods Administration (TGA), along with earlier access to the larger US market.
There is also more certainty around the clinical trial requirements to attain FDA regulatory approval.
“In addition to providing greater certainty and accelerated timelines, regulatory approval by the FDA will provide earlier access to the larger US market while allowing for accelerated mutual recognition regulatory pathways in the European Union, Canadian and Australian markets in the future,” the company stated.
It has appointed Ohio-headquartered Camargo Pharmaceutical Services to develop this strategic regulatory plan.
New chairman brings a wealth of financial experience
Meanwhile, Lifespot has announced the resignation of Rodney Hannington as chairman and director of the company, and will be replaced by Mr Williams with immediate effect.
Mr Williams is an experienced senior executive who has had a successful career across the supply chain, health, pharmaceutical and investment management sectors.
He was most recently the chief executive officer of an agricultural investment company with more than $475 million of assets under management.
In the early days, Mr Williams held senior operational and finance roles with large multi-national and listed local companies, having initially commenced his career with tax and legal firm KPMG.
He worked in top management roles for Symbion Pharmacy Services as well as in private equity and investments.
Earlier this month, Lifespot announced the appointment of cannabis specialists Dr Andrew Saich and Darryl Davies as non-executive directors of the board.
The company also appointed Elizabeth Spooner to join Nova Taylor as joint company secretary.
Medihale launch and expansion
During the June quarter, Lifespot achieved breakthrough first sales of cannabinoid e-liquid using the Medihale inhaler system in Australia in partnership with EC Pharma and reported “significantly positive” early patient feedback on the device.
Lifespot and EC Pharma are currently in talks with contractors in preparation for the next stage involving scaling up to Goods Manufacturing Practice (GMP) contract manufacturing.
Other highlights of the company’s quarterly report include net cash for operating activities coming in at $309,000 and total cash reserves as at 30 June of almost $3.46 million.