Difficultes dealing with the EUFrom the motley foolBronchitol...

Difficultes dealing with the EU

From the motley fool

Bronchitol was approved for marketing in Australia in February 2011 and after initially being rejected by a European regulatory committee in May 2011 it was subsequently approved for marketing in Europe in April 2012. That approval was foreshadowed in October 2011 when the Committee for Medicinal Products for Human Use (CHMP) recommending the granting of a marketing authorisation.

That initial European rejection absolutely crushed Pharmaxis’ share price. In 15 minutes its share price plummeted a massive 75%. Ouch that had to hurt!

Investors and management were rightly stunned by the decision as it didn’t seem fairly based or right. Pharmaxis knew that clinicians liked the drug and wanted it on the market. So it elicited peer support and appealed the decision. Pharmaxis won the appeal and the rest, as they say, is history. Although the regulator did extract a pound of flesh, by restricting approval to cystic fibrosis sufferers over 18, compared to six years and up in Australia.