I realize most on this board say DEA cannot reject since FDA and DEA have both agreed to Schedule IV. However, what if in DEA's analysis they came up with some truly troubling data supporting rejection. Is it at all possible that such could happen at this juncture. In such circumstances I would not put it past management one bit to cover thier own rumps and those of big shareholders then dump on retail once again.
Do the Math. There was no mass exit on Friday. The PPS was dropped on less than 150K shares past the support levels into stops and triggering margin calls by the same Institutions who run this show knew existed. There are 100 Million Shares Long Owned by very big players who know everytime the CEO sneezes and wipes his nose clean. These heavy hitters are not kids but play with real money 3/4 of a Billion Dollars worth and haven't unwound their position. The Hedge wants retail shares so they try to divide you and the management, create doubt and in turn weaken your resolve. Don't diminish the biggest reason most of you are here by forgetting that Institutions are here in a large numbers but are stalled at this point because retailers have the shares they need. They need the Hedge Funds to beat up on your resolve so the rest can end up in their hands. That is what is going on. If they are holding then so should you. You will know when they are leaving as the volume will explode and a lift will occur to allow them to exit.
rldcis, this is one of the most unforgiving boards and rightly so because this PPS has seen never-ending drama while tough and diligent retail investors fight this ridiculously unexplainable PPS action with patience and determination. I am sure you have followed this board enought to know this. ANd while I give you the benefit of doubt that you are long and have asked the question in earnest, maybe you could have done some more due diligence and back up your question with some facts or the lack of those.
In my brief research on DEA I dont think they can or have rejected FDA approved drugs. THe approval part belongs to FDA while DEA is focused on how to control, label and distribute novel compounds and drugs, while enforcing the prohibition of ilicit manufacture, movement and distribution of harmful, illegal, banned or unapproved substances.
In Lorc's context, DEA's role is to approve the schedule of this drug, which will dictate the manufactruing, labeling, distribution and dispensing.
Beyond this and based on what I've seen happen in this FUD environment, nothing's impossible but that's just my colored concern.
To reiterate from Kutz: " The original poster is talking about something he clearly does not even begin to understand"
The data are the data, both agencies reviewed the same data.
Sentiment: Strong Buy
The folks in the EU have a different viewpoint to consider when determining new drug applications. I believe they have a stronger barrier to overcome for Population Benefits vs. Risk vs. Cost. As most have government sponsored national health care systems, cost comes to the front vs. benefits. If in reality Belviq brings down the cost from related obesity diseases in a population base under the national health care system we have a winner, and then their is an advantage to paying for those scripts with reasonable risk. I still feel the EU see's lifestyle changes as the cheapest method to lose weight, at no system cost. In my view, they may be wrestling with the efficacy on a broad population base for responders vs. lifestyle changes. There are many annoying, non emergency life threatening medical issues they don't cover in their system, saving their money for the more serious medical issues. Some countries don't cover treatment for women's vaginal yeast infections, leaving the patient to pay out of pocket, but vaginal cancer, & herpes is another story. JMO
Europe is aslo correct in that many new products are not big improvements and they always cost much more.The marginal efficacy thing really hurts in Europe. They want placebo plus 5% which Belcebo only meets for responders,not the totality of patents
It is possible that DEA can reject BELVIQ if DEA found that BELVIQ is an addiction drugs !
If the DEA approve BELVIQ it doesn't mean they won't get the restriction with the approval take a look at VVUS they have their drugs in the market for about 6 months and the sell is way below their expectation and their stock price have drop from $31 to $12 with Qsymia and Stendra in the market
After the DEA testing, they recommended Schedule IV in mid December 2012, just as the FDA did in June, 2012. They started their 30 day public comment period and we are awaiting the slow DEA to answer the public comments and finalize the scheduling and enter it in the federal register.