”US nuclear medicine professionals were flabbergasted to learn in June 2021 that despite the successful phase 3 trial and untainted clinical safety, the FDA issued a “Complete Response Letter” that conveyed nonapproval and futher guidance. It is customary for the FDA and a company not to disclose specifics of what additional data are needed for approval. Regardless of what the FDA asked for, it is superfluous given the impeccable experience of more than 4.4 million patients worldwide in 64 countries using it without significant adverse effects.”
CYC Price at posting:
$1.89 Sentiment: Buy Disclosure: Held
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