That does appear to be the case, WBA. Does the fact that it's a 'De Novo' request that has been 'cleared' by the FDA, mean something different to a full FDA 'Approval' of a new drug? There seems to be totally different language being used than is/has been for SB. And it seems (from this link - https://www.rimsys.io/blog/de-novo-classification-process-a-beginners-guide) that competitors will be able to copy suite straight away and develop a like product. Unlike SB. I wonder what it's priced at. But, it does look like more competition.
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