AVAX Technologies Inc (AVXT)

[katter]

I googled awhile, found one place that "proposed" a year to get results in.
I assumed it was a clinical trial, but not sure....

In another place...
https://www.clinicaltrials.gov/ct2/manage-recs/fdaaa#DelayedSubmission

Delayed Submission of Results
Certification

A Responsible Party may delay the submission of results until the deadlines described below by submitting a certification (see note) that an Applicable Clinical Trial meets either of the following conditions:

The trial reached its Completion Date (see Primary Completion Date data element) before the drug, biologic, or device is initially approved, licensed, or cleared by FDA for any use (referred to on ClinicalTrials.gov as "certify initial approval").
Results deadline: No later than 30 days after the drug or device is approved, licensed or cleared by the FDA
The trial studies a new use of an FDA-approved drug, biologic, or device (that is, a use not included in the labeling), and the manufacturer of the drug, biologic, or device is the sponsor of the trial and has filed or will file within 1 year an application to FDA for approval or clearance of that use (referred to on ClinicalTrials.gov as "certify new use").
Results deadline: 1) The earlier of the date that is 30 days after the date that:
The new use of the drug or device is approved, licensed, or cleared by FDA
FDA issues a letter for the new use of the drug or device, such as a complete response letter
The application or premarket notification for the new use is withdrawn without resubmission for no less than 210 days
or 2) 2 years after the date a certification is submitted, if none of the events listed above has occurred

Note: If a Responsible Party that is both the sponsor and the manufacturer submits a new use certification, this certification must be made with respect to each Applicable Clinical Trial that is required to be submitted in an application or report for licensure, approval, or clearance of the use studied in the clinical trial.

See the statutory provision for Delayed Submission of Results With Certification (PDF).
Extension Request

The Director of the National Institutes of Health (NIH) may extend the deadline for submission of results information for an Applicable Clinical Trial if the Responsible Party submits a written request that demonstrates good cause for the extension and provides an estimate of the date on which the results information will be submitted. Pending publication is not considered good cause for an extension.

See the statutory provision for Extensions (PDF) for more information.
Submitting a Certification or Request for Extension for Delayed Submission of Results

A certification or request for extension is submitted via the Protocol Registration and Results System (PRS). A trial must have a ClinicalTrials.gov Identifier (NCT Number) prior to submission of a certification or request for extension. Submission of this certification will facilitate automated identification of trials that are not yet required to submit results.
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Are There Penalties If I Fail to Register or Submit Results?

FDAAA 801 establishes penalties for Responsible Parties who fail to comply with registration or results submission requirements. Penalties include civil monetary penalties and, for federally funded studies, the withholding of grant funds.

See the statutory provisions amending Civil Money Penalties (PDF) and Clinical Trials Supported by Grants From Federal Agencies (PDF) for more information.