A range of things from the cohort of people selected for clinical trials to the composition of the plastic in the whistle itself. My thoughts are that the FDA will protect incumbents as long as possible. I think it would be naive to think that Govt agencies in the US are not open to a a little manipulation, esp from financial juggernauts like pharmaceutical companies.
Anyway I hope it finally gets approval but I think on the adjusted timeline it won't occur for another 3-4 years.
A range of things from the cohort of people selected for...
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