Microbio Co., Ltd. announced that due to the change in FDA review requirements, the company has withdrawn 510(k) application of MB107 cream medical device. New drug name or code: MB107 Indication: One of Microbio developed medical devices creams for skin barrier repair. Planned development stages: To obtain the Substantial Equivalence by FDA.

Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis): As per FDA?s suggestion, Microbio has withdrawn 510(k) application of MB107 cream medical device. (2).Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense or an occurrence of other major impacted development of a newly medicinal products, the risks and the associated measures the Company may face: NA (3).After obtaining official approval, the results of clinical trials (include interim analyses) which are statistically significant, the future strategy of management direction of the company: NA (4).Accumulated investment expenditure incurred: No disclosure in considerations of future marketing strategies. 6.Upcoming development plan: Scheduled completion date: As per FDA suggestion, Microbio will resubmit a 510(k) application for medical device MB107 cream to the U.S. FDA after completing the medical device clinical trial and obtaining the clinical trial report.

The company had a pre-submission meeting with the U.S. FDA last year. The U.S. FDA agreed on MB107 as skin topical cream to be submitted in accordance with the medical device 510(k) regulatory pathway, and received a response that the indication is exempted from clinical trials. However, due to changes in FDA review requirements, additional clinical trial data for medical device need to be provided.

As per FDA's suggestion, Microbio has withdrawn the application. After completing the clinical trial this year and obtaining the clinical trial report, the company will resubmit the 510(k) application to facilitate the final review by the regulatory authority. MB107 is one of the many medical devices under development, and the re-submission will not affect the company?s business.

According to Guidelines by Taipei Exchange on the Material Information Announced by Listed and OTC Companies, new drug development companies shall make public announcement when filing application for a clinical trial to domestic or overseas regulatory authorities with respect to its receiving approval or disapproval, obtaining the statistical date of endpoints in each clinical trial (including interim analysis), and/or receiving approval or disapproval on drug license application.