Takeda claims they had nothing to do with the violation. of the conditional approval
OREX drug only had conditional approval. This is precisely why the FDA required the light study in first place to assess whether the known cardiac risk increases, decreases or stays the same with the two generics. If Silverman is correct with the potential action that the FDA can take, I think the FDA could pull Contrave off the market because it was a conditional approval. OREX violated the conditions of the conditional approval knowing the FDA cut them a break the first time they violated integrity of the light study. OREX should have consulted the FDA before handling the interim data. They likely knew what the answer would be from the FDA and went ahead at their own peril and violated the conditions of approval. If I were the FDA I would pull the product off the market except Tekada owns the marketing license, which is where the FDA will have problem being creative here. It will be interesting to see what the FDA does and its rational. The marketing rights are owned by Takeda. The bad actor is OREX. Takeda claims they had nothing to do with the violation. This is the only hang-up I have with the FDA pulling the drug off the market. Whatever the punishment the FDA decides on will be bad for the partnership, OREX and OREX's shareholders in my opinion. It just can't happen any other way. I think the FDA is waiting for a decision by the DMC to see if the study can be salvaged, but if not, I think Contrave is dead
On October 8, 2010, the U.S.Food and Drug Administration (FDA) announced a recall of Meridia, a prescription drug prescribed to assist patients with serious obesity. The drug, which was marketed in the United Statesby Abbott Laboratories, has been linked to a number of serious cardiac problems. The recall, which was made in conjunction with Abbott, will no longer be available for use in the United States.
The naltrexone slow-release (SR)/bupropion SR combination
The active ingredients have been used in humans for more than 20 years. Bupropion has neuronal effects that lead to reduced energy intake and increased energy expenditure, whereas naltrexone is expected to potentiate this effect.14,15 The drug combination was evaluated by the Endocrine and Metabolic Advisory Committee on December 7, 2010, and similar concerns to those exhibited by sibutramine were raised.
If the FDA pulls this drug betw6 am Monday this stock will open under $1
At that time I want to see what some of these shareholders holding have to say
Have a great weekend
Spector Roseman Kodroff & Willis, P.C. is one of the leading law firms, recovering billions of dollars on behalf of investors, consumers and businesses in areas such as securities fraud, consumer protection and antitrust.
With U.S. offices in Philadelphia and Washington, DC, and affiliated offices around the world, SRKW and its global team help look after clients’ interests wherever they are impacted — the only plaintiffs’ firm providing its U.S. and international clients with truly worldwide protection
I hope this helps
Interesting....because if everything was true...Orex would be at $30. This is a 65 billion dollar market. What was indicated was a blockbuster drug
Instead people got a allegation that could not be substantiated that drove the stock sky high and then fell in a second. You made a good trade. You did not lose money
look at the facts.......I said the facts....open and shut case
Actually in this situation.....now that we are talking about it.....will take this case for nothing.
Its a win for the shareholders who lost money
The court will order OREX to pay the legal fees
Good luck with that argument. From the high...OREX is down 30 percent from the high if not more
The significance of the FDA is crucial to the next day trading pattern and the sudden decline in the value of the stock in afters. whats more significance is that OREX did not produce the documentation that was needed to bash the claims of the FDA. The damage was already done at the release of the FDA information and the close of the following day.
Yes. Some actions are better suited for an individual action, rather than a class action. This is often the case where an investor has suffered a particularly large loss or when a currently pending class action is being led by investors that are unlikely to adequately protect the interests of all members of the class, particularly the interests of foreign investors. The U.S. legal system relies heavily on a system of private enforcement by investors who bring class actions on behalf of all investors harmed. As Congress recognized in 1995: “Private securities litigation is an indispensable tool with which defrauded investors can recover their losses without having to rely upon government action. Such private lawsuits promote public and global confidence in our capital markets and help to deter wrongdoing and to guarantee that corporate officers, auditors, directors, lawyers and others properly perform their jobs.”The U.S. Congress reaffirmed in 1995 that “private lawsuits promote public and global confidence in our capital markets and help to deter wrongdoing.”The most common defendants in a shareholder action are the company and certain high-ranking officers such as the CEO and CFO. Various directors of the company may also be sued, although this happens less frequently. A small percentage of cases involve suing the Company’s outside auditor when the company's financial statements are falsified. When the action involves an initial offering of securities (e.g., stocks or bonds), the banks that underwrote the offering may be sued as well, on the grounds that the registration statement contained false and misleading information.What does a typical lawsuit allege? Although every lawsuit depends on its own circumstances, the most common claim alleged is that the defendants made certain false and misleading statements about the company, thereby artificially inflating the price of the stock. Once the truth becomes known, the stock price drops and investors lose money. The false statements that artificially inflate the stock are usually made in (1) annual and quarterly financial reports, (2) press releases, and (3) conference calls with analysts.
Again, the FDA is the lynch pin in this situation. The statements made were the decision of a panel.
Thats the beginning and the end of it for me. Once they said that you can be assured the were no and will never be a approval for the health benefits of the heart.
All that needs to be proven is the FDA stated. Show me the paperwork for approval of the health benefits of this cocktail? If OREX had it they woukld of produced it. If it was a verabl conversation between the panel and the FDA and the CEO and CFO, the FDA would never have said a thing.
all these law firms are seeking a legal remedy to the situation
Thats the begining and the end of it and the star witness in a Federal Court is the FDA and the panel and the documents thay have
Sarcasm seems to exercise the brain more than sincere statements do. Scientists who have monitored the electrical activity of the brains of test subjects exposed to sarcastic statements have found that brains have to work harder to understand sarcasm. Sarcasm so saturates 21st-century America that according to one study of a database of telephone conversations, 23 percent of the time that the phrase “yeah, right” was used, it was uttered sarcastically
Sarcastic statements are sort of a true lie. You’re saying something you don’t literally mean, and the communication works as intended only if your listener gets that you’re insincere.
I get it....and I see you have a strong buy opinion on the stock....it hurts doesn't it
There is nothing to sustain the argument that Contrave has heart benefits. The FDA must approve it for that and as I recall, they doubt it. Therefore in the timetable of events, OREX has a really big issue
I was approached by the CFO of a publically traded company .a man of integrity
He explained the problem. I agreed to review the problem an report back to them
I flew into the city and they drove me immediatly to the site the (CFO and CEO)
For the next 72 hours I examined all the data and took 3000 photgraphs
I was taken to the airport and flew home and produced a report the next day
The CEO and CFO took the report to the insurance company and they settle immediatly
It was the larget insurance claim that was ever settled within a 24 hour period
The facts are the facts guys