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Gen2 is just a simpler,Dont'a Hightower Jersey, more efficient form of the Medtone device.The FDA,Kyle Juszczyk Jersey, despite their recent risk-averse nature, will look at the bio-equivalency data and if it meets their goals of showing bio-equivalency and the device data addresses their concerns which arose with the Medtone device, then they will approve it.Believe it or not, the FDA wants better drugs to hit the market to benefit patients, but they want to ensure they are safe and without undue risk.That is exactly what Afrezza with the Gen2 inhaler is.There is absolutely no reason why any new trials would be needed if bio-equivalency was clearly proven in the studies included with the resubmission.
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