RE: Pumped n dumped7 Jan 2022 11:29
OAP - below is from H1 financial report.
It appears the study will be complete in late 2022 but the regulatory approval will be in 2023 and that is what triggers the payment. So i would add at least 6 months onto your expected timeframe, frustrating as it is. 2022 is all about US progress IMHO.
Feraccru® is not yet approved in China. The Chinese regulatory authority (CDE) has approved an Investigational New Drug (IND) application for Feraccru® which was submitted by our Chinese licence partner, ASK Pharm, to conduct two studies which CDE has confirmed are sufficient to support a New Drug Application: a 12-week Phase III study in 120 Inflammatory Bowel Disease (IBD) patients and a pharmacokinetic/pharmacodynamic study to be conducted in parallel. Clinical supplies have been manufactured and released for the study, and ASK Pharm has started screening patients. The study could be completed by the end of 2022 and marketing approval and product launch could follow by late 2023. On approval, Shield is due to receive an $11.4 million milestone payment from ASK Pharm and tiered royalties of 10% or 15% depending on the level of net sales, and up to US$40 million in milestone payments upon the achievement of specified cumulative sales targets. ASK Pharm will be responsible for all clinical and regulatory costs and activities as well as all manufacturing and distribution costs of goods sold in the territory.