Holmes appeared in a San Jose courtroom on Wednesday.
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RELATED: Theranos founder Elizabeth Holmes set to go to trial next summer
She and former Theranos president Ramesh Balwani are facing multiple fraud and conspiracy charges stemming from allegations they engaged in a multimillion-dollar scheme to defraud investors, doctors and patients.
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Both defendants have pleaded not guilty and say FDA and FBI documents will rebut those charges.
RELATED: When Theranos' remarkable blood-test claims began to unravel
The FDA has 75 days to provide those documents.
Holmes could face 20 years in prison and a fine of $250,000 for each count of wire fraud and for each conspiracy count if she's convicted.
VIDEO: Theranos founder Elizabeth Holmes due in court
Theranos founder Elizabeth Holmes due in court