Where We Stand26 Apr 2024 19:51
Time to look at the upside and downside of GDR at present.
Positives
AIHL
1)The company now has a research partner, a leading multi state physician group within the USA "to support clinical studies required for engagement with the FDA to progress the regulatory approval of the Genedrive MT-RNR1 ID Kit into the USA." In the interims we were told that this organization has "broad coverage of neonatal intensive care units nationally". So ideally placed.
2)GDR also has a distributor agreement with International Biomedical Ltd "to support the FDA study and future sales in the United States ". So a 2 pronged approach to progress to approval in the US.
3)Can be used in the NHS with the NICE conditional recommendation.
4)New sites already announced in the IMC presentation.
5)Potential £100m market in the UK.
6)Specialist Commissioning being pushed for.
Stroke Test
1)Public consultation which started in May 2023 finally ended today after multiple delays. Publication date is scheduled for the 10th July....though NICE approval could come earlier James Cheek in the IMC presentation: "Cannot see any reason why anything will change to the final recommendation".
2)UKCA certified which permits sales within the UK.
3)DEVOTE study anticipated completing in May with submission shortly thereafter.
Negatives
AIHL
1)The de novo submission to the FDA is anticipated to start in late 2024, subject to funding, according to the CEO in the IMC presentation.. So some way off and the caveat of "subject to funding". But the new partnership should help!
2)Specialist Commissioning might not be before April 2025 though earlier approval is being pushed for.
Stroke Test
1)The review process following the DEVOTE study is anticipated to take 5 to 7 months, so some way off.
Finances
Positive
1)No Riverfort overhang at present.
Negative
1)Urgent need to raise funds.
So there we have it. Lots of potentially positive news flow but the elephant in the room is the urgent need to raise funds.