Seems either DEA is on the take or they have shown 1000s of people just how severly they lack in what they do for a living. What is it 1 paid off doctor making a fool out of them ? Is there not something that can get these little overpaid bureaucrats off thier duffs ? This has gotten totally rediculios.
it is up to arna and eisai to put some pressure on the cali senators and congressmen to start lobbying the dea but just remember the manufacturing is not done her so they can't play the jobs card -- we are very much at the mercy of the dea at this point however i suspect the end is close based on the volume of the past 2 days -- someone wanted in and the mm opeaned the door -- if you watched the price action today a great deal of the buying was done on the ask notthe bid while tuesday was just the opposit -- lets see if we get another 9 or 10 mil day thursady that should give us a good indication -- all just my pure speculation -- for what it's worth
They most certainly can play the jobs card. Increased income to ARNA will enable a massive expansion at ARNA on Nancy Ridge Road. That will lead to increased employment throughout San Diego county and hence an increase in the tax base. There is no question that DEA tardiness is harming the economy of southern California.
There are serious consequences and costs as well:
- The $800+ million investment in drug development cost sits idly by waiting for the feds to do a comparatively
simple administrative task,
- Any competitive advantage due to being early to market is being lost while competitors move ahead with their
- Nearly 100 million people who could benefit from Belviq directly continue to be without options,
- The costs of illnesses stemming from obesity continue unabated,
- The general incompetence of the federal bureaucracy becomes more obvious with each passing hour,
Yeah!, we need more government to protect us!!!!]
Exactly. What is big goverment ? What is DEA ? Nothing more than a bunch of overpaid do nothings that get a pay check for nothing. Is it thier policy and procedure outt to destroy every business ? So the only thing left is goverment. What do they do ? NOTHING but they can tell everyone how smart they are. Where are they remotely accoutable for anything.
There is no time limit unfortunately. You would believe they would be addressing such an important drug with haste as America needs Belviq urgently. Only wish Jack or an Arena rep would help out with a little info along the way about the process. IR is a joke over there, PR just doesnt exist.
Sentiment: Strong Buy
Unfortunately you are right - no time limits. Can you imagine in the 'real' world how much time your boss would give you to get through 68 responses - of which half or more are a complete waste of time and could have a form letter as a response. It would maybe take 2-3 days to establish 3 piles - A) not appropriate, B) some valid points, C) worth exploring. The FDA approval was incredibly painful for the other side as they bet wrong. The DEA recommendation was a given once past the FDA, but they know that the final classification, which releases the product, is the battle ground and what I believe his is all about.They know that once Belviq is released, this will destroy the competition, and people with big money are very exposed. Although I do not believe they can change the recommendation, I do believe there is potential for the asking of favors from influential higher ups to prolong, extend, or delay this final decision until things get balanced out - so to speak. It doesn't take much for a supervisor to ask an evaluator to set aside this project for just a week or two while I have you work on something with a higher priority. Do that a couple of times and you've extended this process a month. I can only imagine the phone calls and secret meetings that are taken place with this much money at risk. Unfortunately, I do not trust our government or their agencies to execute anything on time or on budget - for obvious reasons - LOL. JMO
You would think so but guess they have thier heads up thier tail . So how many on this DEA panel vested on the short side of this ? All of them ? I would like to know who investigates them ? No one on this board seems to know.
I forgot to add but I based my response from the following Schedule II drug from 2009:
NDA Approved: 11/20/2008
DEA Proposed Schedule: 02/17/2009
DEA Final Schedule Rule: 05/22/2009
DEA Proposed Schedule to Final Approval, took a little over 3 months.
I could not find any relevant data for their scheduling protocol. I am not sure when the DEA Proposed Schedule was listed but it will probably take about 3 months from that day. I read the date that it was proposed but forgot. It was either in January or February. So if January, I would expect the Final Schedule to be made before the end of the month.
However, if the proposed schedule was in February, then it could be well into April before the schedule is released.
The DEA will delay as long as the bribes keep flowing in....The more scrutiny they get, the more
it will cost the HF's to maintain the delaying action....Let the DEA take their time...Screw the HFs..
Hope their carry costs go through the roof, too.
Sentiment: Strong Buy
So you say DEA can do as they please with no oversight from no one ? Surely there comes a point in time where someone says enough is enough ? They have it pretty good when they can just take thier sweet time and destroy a company at the whish of thier little wand.
who cares, don't worry about it. I'm playing with SRPT, TSRX, and NOK while I wait, and in the meantime my $1.81 shares are LTCG now, I just saved a lot of money. I sold a little bit to buy more 'assault' rifles and other stuff the loons want to ban (my Barrett is on the way). I got POFs, SCARs, LaRues, LWRCs, a NEMO, Armalite, Knights, Sigs, and the list goes on. Thanks ARNA!
Sentiment: Strong Buy