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Theyre wanting a certain amount of certitude that, frankly, is appropriate for most drugs, but not for this moment. Regulatory shortcuts exist that would allow the FDA to skip the more laborious approval process

Retrieved 18 March 2008

The MCV was calculated using an HumaCount 5D hematology analyzer (Human GmbH, Wiesbaden, Germany), which provided estimated information on red blood cell volume and shape and size (20)