RE: Preliminary results19 Mar 2020 16:11
Our US consultants have implemented all of the recommended near-term strategies in the FDA guidance, including implementation of remote/video monitoring (which is ongoing at the moment). In fact, we implemented those strategies more than a week ago, before FDA provided guidance, and we think the monitoring staff are now comfortable with working this way. We have educated the CRAs on COVID-19 so they can interact with the sites effectively. Our US consultants have sent a letter to update the investigators. And the IRB has been updated on study status.
Our US consultant think we are far ahead of the curve on this issue and will continue to watch closely. However, if the FDA does recommend that sites be closed we will abide by their guidance but as yet we have not reached the state.
In respect of the TFDA, Oriental Europharma, our commercial partner in Taiwan is proceeding with its regulatory submission with the TFDA and in fact they sent us the recent feedback from the TFDA earlier this week. And also Fosun is liaising with the NMPA so the NMPA is shut down.
So in short the post is inaccurate.