Setback for Rockeby in US
Monday, 14 November, 2005
After a meeting with officials of the US Food and Drug Administration, fungal infection diagnostics specialist Rockeby Biomed (ASX:RBY) has mothballed its attempt to register its point-of-care CanDia5 test for vaginal thrush infection (candidiasis) for use in the US.
After reviewing records of the company's clinical trials, FDA officials asked for additional information, and put Rockeby's 510(k) applications on hold pending the outcome of a clinical data audit.
Rockeby cited the time and expense involved in complying with the FDA's request for additional information as the reason for its decision. It said it had decided to focus its attention on Europe, where the near-term business opportunities were "more stable".
The company said it would address the FDA's requests later, when it has the resources to comply. It has already succeeded in having the CanDia5 test registered as an over-the-counter test for sale and analysis in European pharmacies, which will allow pharmacies to dispense anti-fungal medications on confirmation of a thrush infection, without the involvement of a doctor.
Rockeby says it has been negotiating with several big pharma suitors since June on a pan-European licensing agreement. Retail pharmacy chains in the UK are also interested in the test.
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