Why would the federal government not approve it.....for many reasons just like they stopped the last NVIV request a few months back because they wanted complete data from the INSPIRE study. If you have never researched the revolving door and politics of the decision makers at the FDA which works hand in hand with pharma, biotech, and other industries I would encourage you to do so. Should it work this way? Probably not but reality is ugly sometimes.
As for your assertion of 3 to 4 months. NVIV may get the patients in the that time frame but with follow up of six moths, submission to the FDA of the required paperwork and review it will be closer to fourteen months minimum before there is an answer.
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