StockMarketWire.com - Diurnal Group said it had tendered an intent to submit letter to the European regulators to seek marketing approval for its congenital adrenal hyperplasia treatment.

The 'Intent to Submit letter' followed a positive meeting with the European Medicines Agency in March 2019 and written formal Scientific Advice from the EMA in April 2019 confirming the current clinical and regulatory path for Chronocort as a treatment for patients with congenital adrenal hyperplasia, the company said.

'The Scientific Advice was based on detailed analysis of data from the Group's Phase 3 study, the largest ever clinical trial programme in CAH, and the open-label safety extension study,' the company added.

Diurnal said it remained on track to submit an application for marketing approval for Chronocort in Q4 2019 based upon the existing clinical data, including 'additional data which will be required to support Orphan Drug Status in the treatment of congenital adrenal hyperplasia..'

'We believe that Chronocort represents a valuable treatment option for patients suffering from congenital adrenal hyperplasia, in a market estimated at $250 million in Europe, and we look forward to submitting our dossier to the EMA in Q4 2019.'


At 10:04am: [LON:DNL] Diurnal Group Plc share price was +0.5p at 33.5p



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