the only simple conclusion is that the FDA called this meeting so they have questions about the safety of the diet drugs that are being developed. They have already made OREX do a pre-approval safety study so I think they will have to support that as the normal process.
normally some reuters reporter reads the summary and writes a story.
There should be one on monday that says "FDA concerned about safety of diet drugs - wants more testing" and that could easily push VVUS down 10%.
The outcome of the actual meeting could move the stock in either direction. If the advisory panel supports pre-approval testing then VVUS is dead. It could get nailed by the advisory committee and then get rejected by the FDA in april for a double whammy.
If the panel is more benign VVUS can rally after the advisory meeting but the FDA risk still lurks in april
I was looking through the briefing docs for the first advisory panel meeting and I couldn't actually find the 1.3% rate of serious cardiac adverse events (maybe I just missed it) but it is strange if the data changes after re-analysis. In any case time will tell. Maybe there will be some support for VVUS in window dressing but that could be dangerous given that the FDA advisory panel could really nail VVUS.
My opinion is that the FDA has been burned with these types of drugs before that showed even less obvious risks in testing and the FDA have already showed how it will treat these drugs by the action they have taken with OREX - 10,000 patients in a safety trial
The FDA looked at all 3 obesity drugs candidates: Qnexa, Contrave and Lorcaserin. Each drug had a different primary concern for the FDA:
(1) Qnexa - Teratogencity risk
(2) Contrave - Cardiovascular risk
(3) Lorcaserin - Cancer risk
As you may know, the Adcomm meeting on March 28th & 29th will not be specific to Qnexa, but will address in general what the pre-approval and post-approval cardiovascular assessment study requirements should be for all new obesity drugs going forward.
Each drug's NDA has to stand on its own merits. The results of each obesity drug's clinical and pre-clinical studies and trials should be evaluated independently.
Also, the Risks-vs-Benefits analysis should be looked at for each drug. With Contrave, the average study subject only lost about 5% to 7% of their body. With Qnexa, the average subject lost about 10% to 15% of their body weight.
One of the main reasons that this panel was planned and scheduled was because of the NDA and the subsequent CRL issued for Contrave. There was a slight increase in heart rate along with an increase in blood pressure for patients taking Contrave. This was a possible signal for cardiovascular risks associated with Contrave. In addition, there was 1 death that occurred from a presumed myocardial infarction in a Contrave treated patient. As a result of all of these factors, the FDA required a pre-approval cardiovascualar study from Orexigen for their drug Contrave.
The FDA did not see the same possible cardiovascular risk signal with Qnexa and Locaserin. While there was a small increase in heart rate with Qnexa (1.6 beats per minute), there was also a decrease in blood pressure, which is a cardiovascular benefit.
As one panel member mentioned during the Adcomm on February 22nd, "it would not be fair to Vivus for the FDA to keep moving the goal post and start asking for and requiring different things at different times".
Vivus has been in constant and continuous communication with the FDA since 2010. I believe that they have reached a common understanding and agreement that there will be a Qnexa post-approval cardiovascular study undertaken by Vivus.
While the upcoming panel on the 28th & 29th will be important for future obesity drug candidates, I do not think that it will impact Qnexa very much.
In my opinion, the panel will recommend that each drug should be looked at individually. If the pre-clinical and clinical studies show a strong signal for major cardiovascular risk, then I think the panel will recommend that a pre-approval cardiovascular study be conducted by the new drug sponsor. In my opinion, the major cardiovascular risk signals will be:
(1) a significant increase in MACE events for patients exposed to the new drug, compared to the placebo.
(2) a significant increase a heart rate.
(3) a significant increase in blood pressure.
(4) a death attributable to an adverse cardiovascular event occurs, during clinical trials, for a patient exposed to the new drug drug.
Contrave was the only new obesity drug that had all 4 of these events occur. That was not the case for Qnexa or Lorcaserin.
What's interesting is that the FDA asked Vivus to remove the contraindication for women of childbearing potential (WOCBP). The only contraindication now (according to the Advisory Briefing Committee Document) with respect to teratogenic risk is for women who are pregnant or become pregnant while taking Qnexa. Seems like it was addressed....
You seems like to me retard , who is on some kind of depression medication like Prozack or zolfact... or some one just got out from Rehab center...
what you talking about...Man.. do to you den and take those some more pills and take nice nap...
For whatever reason the FDA could reverse the committee's recommendations about Qnexa? Unfortunately there is a lot of money made off of uncontrolled hunger - fast food, diet plans, health clubs and medical treatments to name a few. Maybe the people in power just don't want fat people to find something to control hunger. I hope Qnexa will work and get approved and the companies that sell junk food go bankrupt, but I'm still invested in some fast foods and junk foods because I believe that too much of our leadership doesn't hear people who ask "What are you suppose to do when you are still hungry?"