In the complete response letter there are no requests for new pre-clinical or clinical trials.

在该完整回复函中，FDA并未要求补充新的临床前或临床研究资料。

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The complete response letter does not contain requests related to the December 2009 observations from the FDA's pre-approval inspection at the Ohio manufacturing facility.

该完整回复函并不包括2009年12月FDA对俄亥俄州生产车间的批准前现场核查有关的要求。

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But the U.S. Food and Drug Administration's complete response letter did not request additional clinical trials for the drug, Saphris, and included proposed product labeling for the medicine.

但是，美国食品与药品管理局（FDA）完整的意向函并未要求更多药物的临床试验。 Saphris被提议为此药物的药品标签。

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The FDA issued the first complete response letter rejecting the sNDA last June.

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We continue to believe that the FDA is highly likely to issue a second Complete Response Letter to MannKind.

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The initial complete response letter, which was issued in the spring of 2010, cited risk management and manufacturing issues.

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