Cel Sci Corporation (CVM)

[Biobonic]

Clinical Trials dot org is an FDA regulated entity

The requirement to update is regulated...federal register

The final rule also lists Study Completion Date as a required registration data element under §?11.28(a)(2)(i)(U) and specifies the data element definition in §?11.10(b)(41) as “the estimated or actual study completion date. Once the clinical trial has reached the study completion date, the responsible party must update the Study Completion Date data element to reflect the actual study completion date in accordance with §?11.64(a)(1)(ii)(J).” We have included the study completion date as a component of clinical trial registration information in accordance with the statutory authority in section 402(j)(2)(A)(iii) of the PHS Act, which permits the Secretary to “modify the requirements for clinical trial [registration] information” by regulation, provided that “such a modification improves and does not reduce such clinical trial information.” We believe that Study Completion Date is helpful to indicate to the Agency, responsible parties, and the public when all primary and secondary outcome measures and collection of all adverse event information, as specified in the protocol, will be completed and when final data collection for all primary and secondary outcomes and all adverse events has occurred.

As with regulatory agencies - the wording is incredibly obtuse. But the gist seems to be that once the primary study completion date is known and the study is coming to the completion of all data compilation the Study Completion Date should reflect an educated understanding of when the Study will be complete.

definitions from the clinicaltrials website

It is interesting to note that CVM was placed on the FDA's SRO (Significantly Regulated Organization) on the same date at the Clinicaltrial site was updated.

Did the SRO administrator just pick this up?

Was there communication from the Sponsor?

The Sponsor was confident enough in the date to generate it's posting.

Interesting times.