1.Product:ON101
2.Mass production date:NA
3.Effect on company finances and business:
(1)New drug name or code:ON101
(2)Purpose:Treatment of Diabetic foot ulcer.
(3)Planned development stages：NDA review in Taiwan, the second phase3 clinical trial (ON101CLCT04) in the US.
(4)Current development stage:
A.File application:The company has been notified by the contract research organization (CRO)that BfArM has declined the clinical trial application for ON101CLCT04 due to insufficient non-clinical documents and allowed a rebuttal to be submitted within 1 month. The Company will not proceed with rebuttal for the clinical trial application with BfArM.
B.Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks & the associated measures the Company may occur:The European authorities may review data generated by the clinical trials conducted in the US for future regulatory submission. The Company will initiate a second phase 3 clinical trial in the US in 1H of this year, so for strategic consideration, it will not affect the Company’s planning for deciding not to perform the clinical trial in Europe.
C.After obtaining official approval or the results of statistically significant sense, the future strategy:NA
D.Accumulated investment expenditure incurred:No disclosure of the investment expenditure at the moment in consideration of the future marketing strategies to protect the company and investors interests.
(5)Upcoming development plan:The second phase 3 clinical trial (ON101CLCT04) to be conducted in the USA.
A.Scheduled completion date:Aim to complete in 2 to 3 years after initiation.
B.Estimate responsibilities:NA
(6)Market:NA
4.Any other matters that need to be specified:
It takes considerable time and expenses to develop a new drug of which success can’t be guaranteed. Investors shall bear such investment risk that warrants careful assessment before making investment decisions.