In answer to your questions, may I respectfully suggest that you read the report in full, and check the criteria.
Might you have considered cost as an interim barrier for a hasty FDA application? The CLIA lab pathway provides revenue while at they simultaneously accumulate real world statistics in preparation for FDA. It's a very clever strategy.
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2 | 37341 | 0.099 |
1 | 10000 | 0.098 |
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3 | 185500 | 0.095 |
Price($) | Vol. | No. |
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