Expected Timelines25 Apr 2025 10:36
Now that we are near the end of the month I thought it would be useful to show the sources of news which has been highlighted as due soon. Of course there may be delays but this is what the company has previously announced:
1) Specialist commissioning for MT-RNR1, due by the end of the month.
"We continue to pursue all avenues to ensure we achieve specialist commissioning before the current timescale of April 2025. In line with specialist commissioning being devolved to the Integrated Care Boards. (Interims 2024)
"Will specialist commissioning happen by April 2025?" "We remain confident of that." (Gino answering a question in the IMC December 2024)
2)Five new NICUs, taking up MT-RNR1 from May.
"PALOH-UK commenced in November 2024 and has a maximum duration of 18 months, with sites phased into two groups: Group 1, consisting of the nine sites currently using the test and Group 2, the remaining five sites, with phased go-live from May 25" (Interims March 2025)
3)Possible update on discussions with the FDA re MT-RNR1.
"We remain on track for design and initiation of required studies and are in discussions with FDA under the Breakthrough Device Program relating to these." (Final results November 2024)
4)Stroke pilot, due to complete soon.
"genedrive plc (AIM: GDR), the point of care pharmacogenetic testing company, is pleased to announce that a key milestone has been met in The Development and Validation of Technology for Time Critical Genomic Testing ("DEVOTE") programme for its CYP2C19-ID kit. The programme has now passed the patient numbers required for a subsequent submission for an in vitro diagnostics CE certification ("CE-IVD"), which is still anticipated in early 2025." (RNS May 2024)
5)CE-IVD for the stroke test, following the pilot programme, due soon.
"genedrive plc (AIM: GDR), the point of care pharmacogenetic testing company, is pleased to announce that a key milestone has been met in The Development and Validation of Technology for Time Critical Genomic Testing ("DEVOTE") programme for its CYP2C19-ID kit. The programme has now passed the patient numbers required for a subsequent submission for an in vitro diagnostics CE certification ("CE-IVD"), which is still anticipated in early 2025." (RNS May 2024)
6)Possible £200,000 unpaid tax credit
"The tax credit for the year was £0.7m (2023: £0.8m)....The £0.7m is a receivable on the balance sheet at the year end." (Final results Nov 2024) Only £500k received so far, so £200k still due.