While I would be pleasantly surprised if AVNR received approval for a broad label I am not counting on it. I don't understand why the EU would do anything other than follow the FDA and approve only for PBA. Perhaps other indications could be approved later once Nuedexta use in the EU has been evaluated.
If the market is expecting a broad label and AVNR does not get it then the initial reaction to the stock price would likely be negative. But I believe it would recover back into the recent trading range or higher, pending the naming of a possible EU partner. Also analysts would weigh in with their thoughts on the impact and adjust their rev and eps numbers for next year accordingly.
With script/pill growth in the U.S. continuing at the recent pace I would expect the stock price will trend higher over the course of the year regardless.
Just my opinion of course.
Sentiment: Strong Buy
In case you haven't been following closely, the broad label does NOT refer to indications outside of PBA. There is nothing on the table except PBA. The issue is whether we get a broad label for PBA, as here in the US, for all PBA patients regardless of underlying neurological condition.
There is no medical reason, none, for this not to be the case, but the EU follows sticter guidelines re: those patients actually tested in the pivotal clinical trial(only MS and ALS). The majority of patients successfully and safely treated for the last two years are NOT those patients, but come from other underlying conditions. This is why, IF a narrow PBA label is granted, then it is not financially meaningful to AVNR of a prospective partner. That decision would be appealed or subsequently withdrawn, and a renewed EMA application would be filed for the next N indications(pain, ALZ, etc.) This all per my conversations with the company.
The real issue underlying the CHMP decision is the economics of Europe and the fact that the governments would have to pay substantially more for a broad PBA label over the ten years of European exclusivity. That is what is actually underlying this event, but will certainly not be put in those terms publicly.
Hopefully this clears it up for you
Sentiment: Strong Buy
Just gordon being gordon. Another one you might not be aware of. Different kind of liar, but a liar nonetheless. Hasn't had much attention lately, so he's been making an effort recently.
We'll get our broad label, but it won't be announced thru gordon, that's for sure.