re: why this is so good! Goodness you are thick. What's the big words you can't understand?
Completed the pre clinical trials. Duh. That's what it says dill. The product has been tested and proven.
Read it again, slowly, follow the text with your finger. This product has been tested in hundreds of animals and in vitro. They don't need to learn anything about the device or improve it (contrast your claim that they will fix VCR later on!).
Once more:
I am pleased to advise you that we have completed the sequence of preclinical implants prior to the
initiation of the final series of studies to be conducted under the Good Laboratory Practice (GLP)
standard. You may recall that these GLP studies are an important precursor to an application to the US
Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) to implant the
HVAD in humans. The GLP studies are a formal requirement for the clinical trials, although they are not
intended to provide new information about the performance of the HVAD.
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