early 2015," said Michael Narachi, CEO of Orexigen. "With both the US approval and this positive endorsement by the CHMP, we will advance our plans for partnership and commercialization of Contrave and Mysimba across the globe."
Europeans will have a new option for treating their obesity shortly. The Committee for Medicinal Products For Human Use, or CHMP, gave Orexigen's (NASDAQ: OREX ) Mysimba a positive recommendation.
Orexigen will have to wait for the European Commission to adopt the opinion in a few months before it can start selling Mysimba. Unlike the U.S., where the FDA often ignores its advisory committee's recommendations, the European Commission is just a rubber stamp on CHMPs opinion. There's been only one time that I know of when the European Commission didn't adopt a positive opinion, and that was due to new information coming to light between the CHMP recommendation and the European Commission's adoption of the decision.
The drug is already approved in the U.S., where it goes by the brand name Contrave; but Europe could actually be more lucrative for Orexigen
A profit of $11.3 million, or 9 cents per share, in the third quarter. + Mysimba EMA approval and authorization most likely Roche bidding to be the marketing partner, Michael Narachi expects marketing clearance from the European Commission in early 2015.
Contrave is 100% success comes with 41% increased scripts ...
Contrave demand swamps Takeda's direct-delivery discount program Contrave sales up as market for its drug that will be worth billions of dollars to be added in the annual sales. Wait for Q4 results..
This could go beyond control !!
$1261 and marching up. $1300 is guaranteed today...by all means.
Any boxer will tell you it's the blows you don't see coming that knock you out. No one saw the Swiss cutting off their nose to spite the euro's face....blown all to hell overnight.
Banks are underwriters to sell to not to buy...Yes but they have not sold anything yet but this all short sellers game plan and unfortunately CEO such a good company is playing with them.
Yamana has clearly indicated that it believes the assessment to "be a gross miscalculation of [Minera Alumbrera's] actual value." Yamana also believes that it has successfully found errors in the assessed value because of the arbitrator using inappropriate methodologies to calculate the value of the property, leading to significant price inflation. As a result Yamana and its subsidiary are actively pursuing an annulment of the assessment.