If the stock drops below $1 (which it appears to be heading towards) it will be delisted. They would need to reverse split to stay in the market.
If a partner is co-paying for the post-approval study (which they almost certainly will) they will have input for the study and this will take time to hash out. I suspect it is details like these that are, currently, underway.
Based on current metrics. The Takeda deal is under-whelming. I would anticipate $40-50m upfront with up to $200m in additional sales and regulatory milestones. A royalty rate in the low 20% (compared to high teens in US) and a co-fund on post-marketing studies.
I strongly speculate Sanofi. Per OREX IR November 2013 Sanofi is manufacturing MySimba for the EU in it's 7 French locations. The FDA updated their Contrave manufacturers list last week Monday to indicate a new EU label (supply chain continuity). This action was performed 3 1/2 days before the EC released the EU approval and was, necessarily, performed by Sanofi. Meaning Sanofi was HIGHLY aware of the MySimba EU approval and, I speculate, is also interested in the launch.
No, Sanofi is doing the EU manufacturing (OREX IR) and I suspect will also do the marketing. They will want heavy input in the post-marketing studies in exchange for partial payment on those studies, so there are many details before an announcement.
Can not link on yahoo but the PR is located in the investor relations section on the Orex website.
I am unable to link the PR from November 2013 on yahoo, in which, Orexigen entered into a manufacturing agreement with Sanofi. It is located in the Investor Relations section on the OREX website.
The partner is unknown but the FDA updated the Contrave/Mysimba manufacturers list this week to include a new EU label (for supply chain continuity). So we do know that there is an additional European manufacturer already.
It's adopted/approved, active on 3/26/15. I posted the direct European commission link on yahoo but they are deleting it. Go to Seeking Alpha I posted the link on the OREX stocktalk board there.
There will be a formal announcement in the near future as per SEC requirements. Right now, you have a brief informational advantage as a direct result of due diligence. I increased my OREX holding by 57.5% after the EC document was posted online this morning.
First off, AH is tremendously over-rated by retail investors. AVNR was -7% AH pre-bell this morning. Currently, it is at +2.68%. Honestly, this means absolutely nothing to anybody serious about AVNR in any direction.
utupua4, do not get mad at me for your poor due diligence. A CRL by definition is a rejection and you're attempting to change that. Notice how the statement you provided has no official CRL FDA feedback, this is completely AVNR. The facts are AVP-825 received a CRL/rejection when it expected a delay. A CRL is significantly more expensive and time consuming and the FDA does not even need to grant a second PDUFA much less in a timely fashion.
As I mentioned NPSP was a profitable short for me, and I posted the trade. Yes, I will short NPSP again. The funniest thing is that I make money on both sides of the action while you only one. Might have to do with your time being spent on chat boards instead of performing due diligence.