Amgen announced that the FDA rejected the new drug application for Parsabiv, but the drugmaker offered no public explanation as to why the application was denied.
Parsabiv is intended for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease.
Amgen's only public statement to the complete response letter was the following: "Amgen is reviewing the Complete Response Letter, and we anticipate a post-action meeting with the FDA later this year to discuss the Complete Response."
While not mandatory, it is still somewhat standard practice for drug companies to provide investors with a basic summary of Complete Response Letters.
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