Clearly I'm a sceptic but I'm happy to be proven wrong. I just don't think it makes a lot of sense to claim it works (in humans) and not publish the data in a high impact journal. No way you just package it up and send it to the FDA but not publish. It would be big news in respiratory medicine if this worked as advertised. It would definitely get accepted for publication.I've said this before but the bar is much lower for medical device approval with FDA and TGA so I'm not convinced that approval means the same thing as it would for a therapy. Have a look how many trials mesoblast has run and still no approval. And yet all their studies are published. TBH I would love it if this technology worked. It's definitely a great concept and it would be beneficial to have an effort free test of lung function + structure. But without the studies it is still a long road I think.
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