What is the data they put in order for regulatory approval

Reference no: EM133587075

Assignment:

With respect to Biological Dynamics, lab developed test (LDT), ExoVita^TM Pancreas in the company's. Kindly answer the following with citation and references.

What is the data they put in order for regulatory approval? Explains in detail.
What was the national and local coverage determination for Medicare they took.
Is there anything that they could have done differently in reg, guidelines, reimbursement approvals / inclusion areas that would have made a difference, or enough of a difference to overcome failure in the studies from the roadmap?
What is the details and timelines of their process, and are they a good template for ExoVita to follow?

Reference no: EM133587075

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