rayonman1 • Jul 4, 2010 1:37 AM
The major unforseen problem with AVNR is they have the same 10 second QT prolongation with their new lower dose quinidine formulation that they had with their original formulation.
So their drug may not get FDA approved.
The previous CEO said he doubted the FDA would approve a dex/quin formulation that prolonged the QT more than 5 milliseconds.
And the FDA and Avanir expected the 10 mg quinidine formulation to prolong the QT only 3 milliseconds.
Given that it actually prolonged the maximal mean QT 10.3 milliseconds in the Thorough QT study, I think it was only reasonable to warn posters the drug might not get FDA approval.
Are you intentionally leaving out that I thought the drug should get FDA approval?