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Tuesday, January 05, 2010 3:00:14 PM
Details are what makes transparency. No transparency, through details of the process, can get you/me in trouble.
I rather focus on the FDA process and what Dean said it basically was a label. Its not, intended use is clearly seen in the FDA flowchart as a approval or move to other decision making process.
This signals not a labeling issue, that is post approval process, but rather a possible long approval process off the equivalence chart and into new techonlogies. Which takes longer and is not what Dean applied for.
So FDA could come right back and say, file again for non equivalence process, the place for new tech to be approved. That takes a long long time to do.
If nothing is on the market like IMGG DVIS, then that is the next step, not approval. Nothing like it, means nothing to equivocate to other FDA approved machines. So we wait even longer, and restricted shares can sold and we do this all over again
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