GBS: Pre-Submission package is with FDA

 GBS Inc. (Nasdaq: GBS), a life sciences company developing non-invasive, real-time diagnostic testing for patients and their primary health practitioners at point-of-care, today announced it has filed a Pre-Submission package with the United States (US) Food and Drug Administration (FDA). The purpose of this pre-submission is to confirm with the FDA that GBS is following the proper steps to conduct the clinical studies enabling it to develop the glucose biosensor according to the FDA regulatory standards.

The pre-submission package will allow the FDA to review the Company’s clinical trial plans and protocols while also providing a forum for feedback on these clinical studies as it pursues regulatory approval. The proposed three step clinical plan involves generation of prospective data, the initial objective is to explore the relationship between salivary glucose and plasma glucose as well as the time course between the two. The next phase objective is the development of the algorithm between plasma and salivary glucose and the final stage will confirm the algorithm and generate data for regulatory submission.

https://finance.yahoo.com/news/gbs-inc-announces-pre-submission-123000873.html