Anavex Life Sciences Corp (AVXL)

[sokol]

Federal law has requirements for reporting clinical trial results, generally no later than one year after completion. However, an extension may be granted. Yet, it seems that an extension should be for good reason and would be limited to prevent indefinitely postponing a complete report.

Under the Food and Drug Administration Amendments Act of 2007, sponsors are required to submit certain results from clinical trials to ClinicalTrials.gov, generally no later than one year after completion of the trial. They can be granted an extension if they submit a request for a delay in posting the data, though the request must be submitted by a certain deadline.

The Food and Drug Administration Amendments Act of 2007 (also called FDAAA) was passed on September 27, 2007. The law now requires that the "Responsible Party" must register and report results for certain clinical trials of drugs, biologics, and devices that are subject to FDA regulation ([see Public Law 110-85, Title VIII](https://clinicaltrials.gov/ct2/manage-recs/fdaaa)). It also mandates that some previously optional data elements are now required. In general, the Responsible Party is defined as the sponsor of an applicable clinical trial. The law also allows the role of Responsible Party to be assigned to the Principal Investigator (PI) if the PI is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of FDAAA's requirements for the submission of clinical trial information. For investigator-initiated clinical trials, NIH is generally not the sponsor and, as such, NIH would not be the Responsible Party. **Under this law, the Responsible Party is accountable for compliance, including accuracy and completeness of the data.** Penalties for failure to register a trial with complete information may include civil monetary penalties and the withholding of federal grant funds.

https://www.niams.nih.gov/grants-funding/conducting-clinical-research/register-trials-gov#:~:text=The%20Food%20and%20Drug%20Administration%20Amendments%20Act%20of%202007%20(also,%2D85%2C%20Title%20VIII%20).