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CYCLOPHARM LIMITED (ASX: CYC)

Cyclopharm Ltd announces USFDA inspection of Kingsgrove facility scheduled for 24 July - 4 August 2023.
Inspection follows last month's confirmation of a six-month review period for Technegas, a lung ventilation imaging agent.
USFDA approval expected to create an initial addressable market of US$180 million per annum for Pulmonary Embolism diagnosis in the USA.

2023-05-09 08:16:00

The USFDA has acknowledged receipt of Cyclopharm's reply to their Complete Response Letter, deeming it complete and eligible for review.
A review goal date of September 29, 2023, has been set, with commercial sales of Technegas expected to begin in the US shortly after.
USFDA approval could lead to an initial addressable market of US$180 million per annum in the diagnosis of Pulmonary Embolism, not including potential applications for other lung conditions.

2023-04-24 09:48:00

USFDA Complete Response Letter Reply submitted, initiating a six-month review process.
Initial addressable market of US$180 million per annum for Technegas in the diagnosis of Pulmonary Embolism.
Cyclopharm building initial inventory of Technegas generators required for US launch.

2023-03-30 10:52:00