Of course there is no guarantees; however the odds of approval with the FDA approval are 99% (Yes approved) and 1% (Not approved)
Tell your boss he needs to take few lessons in probability calculations and hedge his position accordingly... ie, 99 Call Contracts to 1 Put Contract
At the presentation to the JMP Securities Healthcare Conference
on July 12, 2012, the European application status was discussed:
EMA accepted MAA filing in March 2012
– Granted eligibility for centralized procedure by EMA
– UK assigned as Rapporteur
– Sweden assigned as Co-rapporteur
• Filed MAA with Swissmedic in July 2012
The raises a question of the role of a rapporteur:
"Selection of rapporteur/co-rapporteur
The rapporteur is a country-specific regulatory authority within the EU. The rapporteur (reviewer) and co-rapporteur (if needed) are identified from the CHMP members. The selection of the rapporteur is based on objective criteria, to ensure objective scientific opinion and the best use of available expertise at the EMA. The role of the rapporteur is to perform the scientific evaluation and prepare an assessment report to the CHMP. If a co-rapporteur is involved, the co-rapporteur will prepare an independent assessment report, or provide a critique of the rapporteur’s report, at the discretion of the CHMP.
The process for assigning the rapporteur/co-rapporteur is usually initiated at the CHMP meeting following the receipt of a letter of an intention to submit. The sponsor is notified of the apporteur/co-rapporteur once the EMA has deemed a submission admissible.
Ref: very useful paper is available on the topic of How New Drugs
Are Approved in Europe
A time line for approval sets the Committee for Medicinal Products for Human Use (CHMP) opinion at 210 days from the application. This leads us to a date of 7 months from March, or October 2012.
Consequently, that may be the bell-weather flag of the likelihood of approval. So far, the only supplementary data they have requested is the rats' cancer data, already cleared by the FDA.
Because Switzerland requires its own review, this application has also been made. Given that the manufacturing plant is located in Switzerland, this approval also seems likely.
Bump it up.
My theory is that Glaxo will be announced as Arena's EU partner. That fits with UK being the country that organizes the approval report (rapporteur). Could even be possible that Glaxo had some impact on who was assigned to the job. They will do better with the world outside of North America and with Eisai launching Belviq initially. If they wanted to takeover Arena, they would have to make an offer first and Eisai has the option of matching that. So I'm looking for an EU partnership. That will also be a strong stimulus for price appreciation.
Sentiment: Strong Buy