Need to get FDA approval for investigational device exemption - is this a straightforward procedure and likely of success.
"Although the ENDO Trial did not achieve its primary safety endpoint, evaluation of the safety data has revealed an opportunity to improve the clinical algorithm for the use of EndoBarrier Therapy.
This optimized treatment algorithm is specifically designed to reduce the incidence of hepatic abscess and improve overall safety without compromising device efficacy, resulting in an improved benefit:risk profile.
The revised algorithm was developed and approved by an advisory board consisting of 14 experienced EndoBarrier users, representing the fields of endocrinology, diabetology, gastroenterology, and bariatric surgery.
Based on the clinically-relevant efficacy demonstrated in the ENDO Trial, the Company plans to continue discussions with the FDA for the purpose of seeking approval of an investigational device exemption to conduct a new U.S. clinical trial to determine the efficacy and safety of EndoBarrier using the revised clinical treatment algorithm."
GID Price at posting:
2.6¢ Sentiment: None Disclosure: Not Held
