RE: HAD TO add at 65.72 Oct 2020 08:52
Phase 3 study in US still needs completing. Not sure if they will partner with Eton. If they do Eton may need to raise more money to fund the P3 study if Dnl don't fund themselves. From last half year results RNS:
"Chronocort® US: preparing for pivotal studies
During the past year, Diurnal has also refined its US development strategy for Chronocort®, to reflect both previous feedback from the FDA and its own experience with the European Phase 3 study. The design of the US Phase 3 study has now been optimised based on this information and, shortly after the end of the financial year, Diurnal submitted the updated protocol to the FDA for a Special Protocol Assessment (SPA) meeting. If granted, the SPA potentially offers more certainty for ultimate approval of Chronocort® in the US, assuming that the clinical endpoints of the Phase 3 study are met. The Phase 3 registration study for Chronocort® in the US will recruit up to 150 patients with CAH randomised to either receive Chronocort® twice daily or standard of care. The study is expected to commence once the Group has either secured additional funding to run the study or has identified a US development and commercialisation partner for Chronocort®. Diurnal believes that the preparatory work previously undertaken for this study, including identification of key clinical sites, will substantially accelerate the start-up once the study financing has been secured.
Diurnal is also planning a Phase 2 study design to assess the utility of Chronocort® in AI, which represents a sizeable commercial opportunity in the US of potentially close to $1bn, with a highly favourable competitive landscape. Diurnal has developed a protocol for this study, which it intends to commence alongside the Phase 3 registration study on CAH, subject to funding for either in-house development or with the support of a US partner."
All positive. Market opportunity from European approval alone will be huge and the European market opportunity is bigger financially than the US - see page 12-13 of link below which is from the old Feb 2020 results presentation.
https://www.diurnal.co.uk/media/36801/interim-results-presentation-february-2020-pp.pdf