* Says FDA asks additional questions on MelaFind
* PMA review date extended by 180 days
* Says to seek FDA panel discussion
* Shares fall 29 percent after the bell
(Recasts, adds details)
March 24 (Reuters) - Mela Sciences said U.S. health regulators delayed pre-market approval of its skin cancer screening device and sought more details, sending its shares tumbling as much as 29 percent.
The company said it was 'disappointed and surprised' to receive a letter from the U.S. Food and Drug Administration stating that the application is 'not approvable' at this time.
Mela said it received additional questions on the melanoma detection device, MelaFind, from the FDA and its review has been extended by 180 days.
The company is preparing a letter to the FDA requesting a panel discussion on the application. It also plans to respond to the agency's questions in the immediate term, Mela said.
'We believe our data satisfy the study's agreed-upon endpoints and we will continue to work with the agency to move the approval process forward,' Chief Executive Joseph Gulfo said in a statement.
Shares of the company fell 29 percent t0 $6.50 in after-hours trade. They closed at $9.16 Wednesday on Nasdaq.
(Reporting by Krishnakali Sengupta in Bangalore; Editing by Gopakumar Warrier) Keywords: MELASCIENCES/ (krishnakali.sengupta@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800; Reuters Messaging: krishnakali.sengupta.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
* PMA review date extended by 180 days
* Says to seek FDA panel discussion
* Shares fall 29 percent after the bell
(Recasts, adds details)
March 24 (Reuters) - Mela Sciences said U.S. health regulators delayed pre-market approval of its skin cancer screening device and sought more details, sending its shares tumbling as much as 29 percent.
The company said it was 'disappointed and surprised' to receive a letter from the U.S. Food and Drug Administration stating that the application is 'not approvable' at this time.
Mela said it received additional questions on the melanoma detection device, MelaFind, from the FDA and its review has been extended by 180 days.
The company is preparing a letter to the FDA requesting a panel discussion on the application. It also plans to respond to the agency's questions in the immediate term, Mela said.
'We believe our data satisfy the study's agreed-upon endpoints and we will continue to work with the agency to move the approval process forward,' Chief Executive Joseph Gulfo said in a statement.
Shares of the company fell 29 percent t0 $6.50 in after-hours trade. They closed at $9.16 Wednesday on Nasdaq.
(Reporting by Krishnakali Sengupta in Bangalore; Editing by Gopakumar Warrier) Keywords: MELASCIENCES/ (krishnakali.sengupta@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800; Reuters Messaging: krishnakali.sengupta.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.