She's had only a few of these -- ones that were objected to by the government, actually see admission into evidence. But this one will likely prevail. It is from 2015, and it shows Sunny pretty proactively seeking answers for why errant results on PSA levels were repeatedly seen in one test patient (albeit only after the patient's treating doctor complained, and demanded a refund).
But it does go to show that, in at least a handful of cases, the Sunny-Elizabeth duopoly did aggressively seek the answers. What it does not do, is even begin to hint at any remediation / repair plan (for the device, as required by FDA regs) -- nor does it in any manner explain why it took the two of them over a year to even obliquely suggest to the FDA that they were seeing off-target results.
That admission came only after non-voluntary site visits by regulators.
Of course, the relevant FDA rules required immediate submission of full, searchable data-sets on this score -- and it is not disputed that Theranos only ever provided a "locked, no keys" core dump. . . over a year too late.
And throughout, the pair was touting the device and raising hundreds of millions of dollars from various investors.
So -- in the end, this "win". . . isn't likely to amount to much.
Onward, grinning -- to baking and icing some holiday cookies today, with the next-gen babies.
नमस्ते
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