Ann: SNMMI Announcement Regarding USFDA Approval of Technegas, page-18

This explains a few things.

Only trick is finding out how much on the income statements was FDA related expenses.

From S t o c k H e a d
experts/dr-borehams-crucible-30-years-later-has-cyclopharm-finally-convinced-the-us-fda/

The company is confident of snaring half the pulmonary imaging market within three to five years.“Technegas has become the primary agent for ventilation imaging in our other markets and we expect that to happen in the US,” McBrayer says.The company intends to provide the generators for free, at least initially.Because of the reimbursement available under existing codes, the 50-dose patient administration sets are expected to sell for $US7,000 a pop – more than two times the average price in other markets.Cyclopharm is breathlessly awaiting its US entrée, with personnel recruitment and training and inventory build-up “well underway”.The value of inventory stood at $8.29 million at the end of 2022, compared with $2.78 million a year previously.

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Somewhat quirkily for a loss-making company, Cyclopharm pays a modest dividend and has done so since October 2015.The final payout of half a cent took the full year dividend to one cent a share, steady on previously.McBrayer says the company is loss-making only because of the large sum spent on pursuing FDA approval over the years – an impost it does not expect to bear for much longer.“It’s a modest dividend payout – we don’t go crazy,” he says.Broker Bell Potter projects a $6.1 million loss in calendar 2023, morphing to a $3 million profit in 2024 and a $12 million surplus in 2025.