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(Stockholm, 5 May 2022) Inhalation Sciences (ISAB) has received positive feedback from the US FDA (Food and Drug Administration) on its white paper, previously communicated on 17 January 2022, that aims to validate the company's DissolvIt[®] model as an FDA-recommended technology. ISAB has now been invited to submit a full proposal for its research project into DissolvIt[®]. If successful, the FDA will co-fund the project to the value of 250 KUSD (approx. 2.2 MSEK) annually for up to two years.
As communicated on 17 January 2022, Inhalation Sciences submitted a formal whitepaper to the FDA's National Center for Toxicological Research on how DissolvIt[® ]could further improve research and outcomes for inhaled drugs. The paper proposed a research project aiming to make DissolvIt[®], ISAB's in vitro simulated lung model, FDA-recommended - and ultimately to validate it as a recommended standard research method in inhaled drug development.
ISAB has now received positive feedback on its white paper proposal and has been invited by the FDA panel to submit a full proposal, addressing their specific questions, by June 4, 2022.
ISAB CEO Manoush Masarrat: "This reconfirms the FDA's interest in our unique technology, and its potential to become the FDA-recommended dissolution method in the US. Official endorsement from the FDA would be a huge milestone and transformative for ISAB as well as the industry."
The FDA's National Center for Toxicological Research funds a range of research projects and prioritizes those that "spur the development of new regulatory approaches that can help improve predictability" and "replace, reduce and/or refine animal testing" [(1). ]These are all defining characteristic of DissolvIt[®], ISAB's advanced simulated lung model that produces simulated in vitro dissolution / absorption data that closely predicts in vivo data, with no animal testing involved.
1. https://www.fda.gov/science-research/about-science-research-fda