RE: RNS for AGM + Update18 Nov 2022 09:00
Quotes from the RNS informing us of the CTA application:
Sareum, working alongside a specialist contract research organisation (CRO), has designed a Phase 1a/b clinical trial with SDC-1801 in healthy subjects and psoriasis patients.
The CRO conducting and managing the studies has extensive experience in conducting trials in inflammatory diseases and will recruit up to 120 subjects at a site in Manchester, UK.
Synthesis of SDC-1801 drug substance under GMP conditions has been completed successfully, with a surplus of material for the planned Phase 1 clinical trials. GMP-compliant manufacture of capsules of SDC-1801, intended for use in the Phase 1 trial, is also complete, and the capsules are undergoing rigorous quality control checks before delivery to the clinical unit.
The more I read into this the more i believe it is a admin error such as SOG has pointed out... its documentation and certs of equipment/people etc. IF the CRO are as experienced as it seems, having run extensive trials previously, I don't believe this is a serious issue to resolve, but the time will be take by the authorities to review the requested data...
sadly its sit and wait, but... i do believe we will have positive news on this prior to Christmas...as its not a new application but a review of additional data... non clinical data!!