RE: Take this or nothing else!5 Oct 2023 13:46
This bit started me thinking what if Polarean is not giving us the real picture and allowing people in the know to sell their stocks constantly while we argue, speculate and count our losses on a daily basis! :(
“Three-dimensional imaging doesn’t work with Xenon, because it's a low energy isotope. And then technetium DTPA is a wet aerosol that starts to pool as soon as it comes out of the nebulizer, and if there's any narrowing of the lungs, it masks a lot of the functional aspects of the lung … so that’s why the U.S. was stuck back in the 1990s.”
“We even had doctors writing to the FDA, and the Society of Nuclear Medicine and Molecular Imaging wrote to the FDA to try to lobby [the agency] to push our approval through,” he said, noting that Cyclopharm received 420 expressions of interest for the product, so it’s not a matter of “getting a sales force together, it’s about the execution in getting the generators to the U.S. and installing them.”
The phase III trial supporting the NDA was a noninferiority structural ventilation study comparing Technegas with Xenon-133 in 240 patients. The trial met both primary and secondary safety and efficacy endpoints.
Technegas is most commonly used in the diagnosis and management of PE. Over the past three decades it has been successfully used in 64 countries worldwide, amassing 4.7 million patient studies. In each of these countries, the technology has become accepted as the preferred nuclear medicine lung ventilation imaging agent.
“By every measure, we're better than the competing products, and that's why we are named in clinical guidelines in Canada, which is our largest country market, and in Europe, which is our largest region.”
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