The FDA consulting firm will assist in the review of patient data documents from the approximately 500 women tested in clinical trials as well as to review the development process of the First Warning System’s computer based interpretive software.
The processes and their documentation will form the basis for Lifeline Biotechnologies’ anticipated preparation and filing of a 510 (k) with the FDA.
Lifeline CEO Jim Holmes said that the work by the prior FDA consulting firm was partially but not fully completed and as the process has caused delays, they have engaged a new firm to assist in the review of the data. There will be a determination as to the adequacy and completeness of data given the ever-changing FDA requirements.
“The process is expected to lead to the preparation and filing of our 510(k) and we expect to know soon the extent of any additional information this new firm may require in order to complete the 510(k) preparation and submission. Our efforts continue to attempt to re-establish DTC’s services regarding the trading of Lifeline’s shares,” Holmes said.
