Let me begin by saying I am not a disguntled market player who lost money on this stock...
For all investors who lost money I feel very bad for you. For the employees of the company, some who will lose their jobs, I feel worse. What happened here was not right..
The drug approval process in this country is long enough and expensive enough without having to depend on the last minute whimsy of an FDA panel. The FDA should be required to provide specific guidance on what they are going to require. Orex is a perfect example. Its drug is a combination of two already FDA approved drugs, not a substance extracted from a South American root. The FDA clearly had enough clinical information on the active ingredients, and what OREX planned clinically to inform the company two or three years ago they would require a long term CV study for safety reasons...rather than waiting until ten minutes to midnight and the springing it on them.
The FDA's arrogant and inconsistent behavior does little to help medical consumers, raise the costs of drugs, and sometimes puts people out of work...In these hard times...this has got tom stop...
Hopefully my message will be understood as criticism of the FDA, and not a defense of the drug Conclave..
After some DD this is not a strong drug...The thinking behind the drug that overeating is an addiction, and that depression might also play a role is plausable, Conclave' efficacy
however is not that impressive..Welbutron in earlier studies showed weight gain after cessation of cigarettes was less than placibo in the early period, but the effect was short lived...
The drugs weakness no doubt figured into the FDA decision...The point is the FDA should have acted on that much earlier..
FDA are made of many federal retards under the leadership of inexperience commander in chief... who is too busy with talks and promises but no substance... It will take many years for America to correct itself from this administration's damage goods...
GREAT POST.sir... i have a simple answer....read DEEPCAPTURE...MICHAEL MILKEN,60,000 DEATHS & THE STORY OF DENDREON..ONLINE.. a long read but A REAL EYE OPENER.... BIOS PLAIN & SIMPLE are a HUGE RISK at any time but people who have made money on the way up & dont sell anything before any pdufa date are ONLY PLAYING RUSSIAN ROULETTE.. that is FACT.. GL MATE ... PARK.
AGREE. FDA is talking about long term safety data. Frankly speaking every medicine has side effects in long run. Even if you take vitamin pill for long time , it may harm you down the line. Also obese people is always at heart risk. I don't think Contrave has anything to do with that single patient heart failure. deffinitely long CV study is very good for safety, but that could have been done after approval.
Anyone who has taken a pharmacology class will tell you that just because two separate drugs are safe for particular indications does not mean that the drugs in combination are safe for the same, let alone, another indication.
Also, when cardiovascular risk factors change while taking a drug, it shouldn't take an explicit statement from the FDA for the company to understand that studies will need to be done to evaluate the cardiovascular risk of taking said drug.
People here got too caught up in the Ad Comm vote, they failed to realize the FDA is a separate beast. Did you really think the FDA was going to allow a drug that could have cardiovascular risks be "tested" in a post approval study on the a large population who already exhibit severely weakened cardiovascular systems? Maybe 10 years ago, but after the Fen-phen fiasco and all the negative publicity over Meridia?
" anyone who has taken a pharmacology class".. I gather that would be you..
Might you be a pharmacologist, or in the nursing profession..
As a clinician I can say all drugs come with information which includes warnings about adverse drug interactions, for example MAO inhibitors profoundly effect many other drug, sedatives, morphine alkaloids, hypnotics, alcohol all tend to be additive, kind of like drinking whiskey, then beer, or whiskey then more whiskey...Its not that complicated..
The OREX combo is Naltrexone, a "morphine antagonist", and Bupropion, which is a seratonin uptake modifier used as a antidepressant and to curb addictions.
There is no warning information indicating these two drugs should not be given together...or any mention of a possible adverse effects. Both these drugs have been around for 25 years...
FDA is a political institution....imo they were influenced and pressured by Arena and Vivus to ensure that Orex got the same treatment...the fact that they rejected opinion of their own advisors...and to top it off they requested a 'lengthy' study...which basically has killed Contrave now...2-3 year study? I guess Orex will cut jobs, dilute ownership by raising more capital...and basically join the stable of a single drug company that failed to make the grade...Vivus at least has a portfolio...Arena and Orex do not...it hurt my pocketbook today for sure...another fee paid to wall street...and a lesson learned 'you can make money in a stock even after the FDA approves the drug'..so if you want to speculate..go to Vegas and at least have fun losing the non deductible donation...
Ah...when the going gets tough, then the the tough get going. Overall assessment of strengths, and weaknesses can assist the leadership here, and now.
The company obviously believes in Contrave. A majority on the panel believed in Contrave, and I bet some folks at the FDA do too.
So leadership can do another study. That's all well, and good. But that will take time. The best thing to do is to generate some revenue.
By this, I mean take Contrave global. Other countries WILL approve Contrave. Why not go to South Korea for example? Lots of companies gain approval abroad, and come back to market the same drugs back here in the US.
The sell off today was way over done by a long shot. I'm not saying all is hunky dory, but now leadership must lead, and develop a strategy for MAKING MONEY. That can only come from marketing outside the United States.
Yea, but we don't have the ballz to question and uprise against our crooked government like Egypt does!!
Our young people are too busy on Facebook drinking the kool-aide demanding entitlements with low attention spans!
Doom we are all!!!
the FDA has spoken and was very specific on what they want done B4 approval, there were 20% short on this stock based upon the 13-7 panel vote which identified potential issues, those who said the FDA would deny based upon those potential interactions where correct, I was short, I could have been a big LOSER but if you were LONG and had not read the panels opinions then you have no one to blame but yourself,,DD my friends,,,,DD.
...needs to be disbanded. Let the market decide. If there are any side affects, that's what lawyers are for. You can't have the FDA and lawyers suing companies...it's one or the other, and I don't think lawyers are going anywhere. How about lawyers suing the FDA out of existence.
Also write your representatives (unless they're a "progressive" Democrat...they'll try to have you monitored for anti-government hate speech). There is already a cry to get rid of the Dept of Energy & Education, though the FDA should be at the top of that list. Perhaps when they're threatened with extinction, they'll stop this nonsense.