← Return to Beyond Air study using N.O. For MAC and Abscessus
DiscussionBeyond Air study using N.O. For MAC and Abscessus
MAC & Bronchiectasis | Last Active: Oct 18, 2022 | Replies (6)Comment receiving replies
Replies to "Here is information on the company and links to their research and studies. https://www.beyondair.net/"
This sounds like it will be another great tool - when it is available. As far as I can tell, the full report does not exist yet.
Take a look at this diagram:
https://www.beyondair.net/pipeline/
Let's translate the steps:
Preclinical - up to 3 years - the planning and proposal stage - getting permission to try on humans, manufacturing prototypes, getting candidates (done)
Pilot - usually 1-2 years- the initial small study - in this case it was 15 patients in Australia (almost done - data needs to be analyzed)
Pivotal - usually 2-3 years -the FDA required Phase III Clinical study - more people, more places, broader population, longer duration, with follow-up for long-term effectiveness and risks (paperwork undoubtedly started and awaiting final data from step 2)
PreMarket Approval - usually 2-3 years - Complete documentation to the FDA which is then reviewed
Commercial - ??? - funding, manufacturing & getting health insurance to cover.
Optimistically, I would say we are at least 5 years away from this treatment being even available. If NJH, Mayo, University of Texas - Tyler or another Lung Center gets involved, it is possible their patients could get into the clinical trials.
Let's hope this is going to be an option going forward!
Sue