In regulatory filings, company officials said they submitted a pre-submission package to the FDA for its Symphony CGM System for use in the hospital critical care environment, requesting a meeting with the watchdog agency to determine the best regulatory pathway.
"As the company now begins to sharpen its focus on gaining FDA approval, we are committed to obtaining as much FDA input and agreement as possible regarding the design of the pivotal trial. The pre-submission with the FDA is a significant milestone on our path to advance Symphony towards U.S. commercialization. Following the feedback we expect to receive from our meeting with the FDA, we plan to initiate the pivotal U.S. clinical trial for Symphony," Echo Therapeutics CEO Patrick Mooney said in prepared remarks.
The company announced June 5 that it launched a multi-center clinical trial in support of CE Mark submission to European regulators, expecting results during the 3rd quarter.
ECTE shares were down 1.1% to $2.75 each as of about 11:10 a.m. today.