They didn't put out an 8-K about the submission. They haven't been too forthcoming about the submission like what kind of submission it is and what is it for. Only tweets hinting about a submission, and then the meeting with he FDA. So I wouldn't expect any updates via an 8-K.
For example the previous strategy for OvaDx submission was to start with a pre-IDE submission where the FDA gives feedback about what kind of studies/clinical trials are required to get approval. Then the studies are done and a formal submission is done. We don't know if they are following a pre-IDE strategy for whatever they submitted.
26 Jan 2018
Arrayit completes site visit and laboratory tour with a key business-to-business B2B partner and regulatory consultant regarding submission of a proprietary microarray product line to the United States Food and Drug Administration for FDA clearance
14 Mar 2018
Arrayit clinical team submits requested standard operating procedures SOPs and other documentation required for submission of a major microarray technology product to the United States Food and Drug Administration FDA for FDA regulatory clearance
19 Jun 2018
Arrayit CLIA clinical team confirms July 2 2018 meeting with the United States Food and Drug Administration FDA to discuss FDA clearance of a major microarray product line.
3 Jul 2018
Arrayit provides 7/2/18 FDA update: (1) excellent meeting, (2) large attendance by FDA top brass, (3) insightful and instructive, (4) our entire clinical team wishes to thank the agency for their feedback and generosity, and (5) we believe that our test will receive FDA approval.
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