qrx article

FYI

Tim Boreham in the Australian today:


QRXPHARMA (QRX, 64c) has been "blindsided" by the US Food & Drug Administration's refusal overnight to approve its dual-opioid pain-relief drug MoxDuo for the US market, which sent the local shares tumbling more than 60 per cent today.

QRx and marketing partner Actavis had been supremely confident the FDA would green-light the drug, touted as being safer and more effective than the two old-world opioid drugs (morphine and oxycodone) alone.

MoxDuo was targeting a market worth $US2.5 billion annually.

In a four-page complete response letter, the FDA requested “additional information” on the safety and effectiveness of the drug. That's FDA-speak for “we're sorry but we're not convinced your drug works''.

QRx management will seek an explanation at a meeting scheduled for August.

The best-case scenario is that QRx satisfies the regulator with completed trial data that wasn't requested earlier; the worst is further extensive trials or abandonment of the drug. Management expects a six to 12-month delay before the application can be re-submitted.

Lodge Partners bio-watcher Mark Sinatra said QRx appears to have got something “drastically wrong”. He said the drug should have been approved if the company had met all of the trial endpoints required by the regulator.

“I'm pretty gobsmacked by this development,'' one private investor told management. “This is so different to the messaging we had from QRx at every different point.''

Last month, QRx CEO John Holaday told Criterion that he was confident of approval, given the “arduous dialogue'' with the FDA during the application process. But it appears that the FDA's failure to raise concerns was a case of politeness more than anything.


Chins up people. Company still has some fight in it, I'm sure. May entice people to buy at these prices, once the dust settles.