Drug developer Ark Therapeutics said it is confident it has the necessary data to address concerns the European Committee for Medicinal Products for Human Use (CHMP) has over Ark’s brain cancer treatment Cerepro.

The company’s share price took a tumble back in December when the regulator, the European Medicines Agency (EMEA), rejected the company's Cerepro filing for the second time.

Ark lodged an appeal and is to provide data to support re-examination of the main underlying objection from its '904' phase III trial.

It expects to receive a verdict from the EMEA in the early part of the second quarter of 2010.

‘We are confident that we have the necessary data to address the main underlying objection concerning the re-intervention decision in the Cerepro trial. The body of evidence is substantial and robust and we are thus comfortable to file for re-examination,’ said Ark chief executive, Nigel Parker.

Related shares
Ark Therapeutics (AKT) share price