What was corrected and how
A subsequent correction by the company to the contents of an already published filing.
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Items this document does not state (6)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.The Company stated that GCR's report is unacceptable because it is based on one-sided views and assertions. It also explained its views after confirming the reliability of the approval review materials for Amchepri and noting that approval was obtained following scientific and medical review and investigation by the regulatory authorities.