Miromatrix Announces FDA Clinical Hold on IND Application for miroliverELAP
The miroliverELAP IND application was submitted in mid-November.
- The miroliverELAP IND application was submitted in mid-November.
- The FDA indicated they will provide an official clinical hold letter to Miromatrix within 30 days.
- Miromatrix plans to provide additional updates pending communication with the FDA.
- Forward‐looking statements contained in this press release include, but are not limited to: the FDA’s communication plans related to the clinical hold on miroliverELAP, our plans and expectations for discussions with the FDA and the outcomes from the discussions.