chmp will issue positive opinion this month. key point of debate, is beadth of the label. AVNR is going to appeal any decision that limits use of drug to MS and ALS population. positive approval opinion supporting braod label will yield a partnership in europe. revenue for this Q should be about ~17.5 with N sales of 16.5mm.
IMS dada shows N achieved growth of ~11% in C1Q13.
odd you say that senseless seattle because i agree with every point andrew made. Revenues MIGHT come in a little better however due to the strong finish we saw in the Quarter. But that might be offset by whatever supply was in the channel from the quarter before this one. I'll also add that i personally think they'll get broad label approval. Benefitting that point of view is a few things. The FDA approved it that way. ..the safety profile of this drug is really about as safe as you can get....the ingredients are well understood with decades on the market and supplimental data has shown N to be of great benefit across all these primary illnesses. What is chmp going to say...go back and study "kicked up a notch cough medicine" some more and report back to us? Decisions like this sometimes are best analyzed that way in asking oneself what is the alternative? I think that Avnr has shown that PBA is pba..whatever the illness.
Look for broad label approval...and revenues MAYBE beating the 17.5..by a little.
That all sounds about right. The question of this coming week, as you alluded to, is whether a broad or narrow label will be recommended. I think that is a toss-up and I don't think it is wise to bet either way on that.