Shorts Mafias sitting in Brussels
Contact: Ilaria Passarani
Understanding the differences starts with understanding the approval process.
The FDA has established goals that it shoots for when making decisions: currently 10 months for a standard review and six months for an accelerated review. There’s lots of back and forth between the agency and the drugmakers during that time.
The EMA, on the other hand, issues questions to drugmakers during the review process, which stops the clock. The agency shoots for a decision within 210 days — about seven months, excluding clock stops.
The FDA elicits the help of outside experts during advisory-committee meetings, but it isn’t bound to the recommendations the committee makes. The EMA relies on the Committee for Medicinal Products for Human Use, or CHMP, but don’t be fooled by the “committee” part: CHMP doesn’t play the same role as an FDA advisory committee.
In fact, CHMP is essentially the equivalent of the FDA. Technically, CHMP makes recommendations to the European Commission, but the EC’s decision is nothing more than a rubber stamp. The only example I know of where the EC didn’t ratify a CHMP recommendation is Johnson & Johnson’s (NYSE: JNJ ) antibiotic Zeftera, where new information came up between the recommendation and the EC approval. CHMP revisited its decision, eventually recommending against approval.
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.