" initiating clinical trials on new areas most specifically OSA" .
I strongly believe VVUS uptrend is near.
The study demonstrated statistically significant improvement in the apnea/hypopnea index (AHI), a measure of the severity of sleep apnea, in patients with OSA treated with Qnexa for 28 weeks. Qnexa-treated patients also experienced significant weight loss, reductions in both systolic and diastolic blood pressure, and reductions in respiratory disturbances and improvements in overnight blood oxygen levels. Qnexa treatment was well-tolerated. The most common side effects were dry mouth, altered taste and sinus infection.
"Obstructive sleep apnea is a serious condition associated with potentially deadly cardiovascular and metabolic events for the more than 18 million patients living with the disease. Unfortunately, there are no drug treatments available for the condition, and because current treatment options are limited to devices or surgery, patient compliance is low," stated David Winslow, MD. "These positive Qnexa data, from what is considered a sizable study for OSA, are exciting for those of us in the medical community treating obese patients with hypopnea syndrome. Particularly notable are the positive improvements achieved in mean oxygen saturation levels, which are difficult to accomplish and incredibly important. Patients would truly benefit from a safe and effective oral pharmacologic therapy for OSA, and I look forward to further exploring the potential of Qnexa."
OSA is a sleep-related breathing disorder that involves a decrease or complete cessation of airflow despite an ongoing effort to breathe. OSA is associated with an increased risk of hypertension, diabetes, stroke, sudden cardiac death and all-cause mortality. Sleep apnea is one of the leading co-morbidities associated with obesity, and research has shown that weight loss can improve OSA.
No product available for patients that suffers from OSA.
The USA population that are suffering from OSA are huge.
Qsymia Phase II for OSA has shown promising results.
If Qsymia become available for patients that suffers from
OSA this would create tremendous value for VVUS.
Some questions to the board :
1. is phase III needed to approve Qsymia by the FDA for OSA?
2. if phase III is needed what will be the cost of the phase III trial?
3. is VVUS plan to raise money by equity offering for phase III trial
or finance the trial by partner?
3. What will be Wall Street reaction if phase III of Qsymia for OSA to be announced?
1. interesting product/s
2. Hug market
3. Low production cost
4. With management that know how to make execution (focus) !!!
That what makes big and successful company
The value of Qsymia to increase big time.
What Is Sleep Apnea?
Apnea literally means "cessation of breath." If you have sleep apnea, your breath can become very shallow or you may even stop breathing while you are asleep. This state of not breathing can occur up to hundreds of times a night in some people.
What Is Obstructive Sleep Apnea?
Obstructive sleep apnea (OSA) -- also called obstructive sleep apnea syndrome -- occurs when there are repeated episodes of complete or partial blockage of the upper airway during sleep. During an obstructive sleep apnea episode, the diaphragm and chest muscles work harder to open the obstructed airway and pull air into the lungs. Breathing usually resumes with a loud gasp, snort, or body jerk. These episodes can interfere with sound sleep. They can also reduce the flow of oxygen to vital organs and cause irregular heart rhythms.
Who Gets Obstructive Sleep Apnea?
According to the National Heart, Lung, and Blood Institute, more than 12 million people in the U.S. have sleep apnea. Of the total, more than half are overweight. Those figures also estimate that one in 25 middle-aged men and one in 50 middle-aged women have sleep apnea. If you are related to someone with sleep apnea, you are more likely to develop sleep apnea yourself.
Sleep apnea is more common in men than in women. It is also more likely to develop in African-Americans, Hispanics, and Pacific Islanders than in Caucasians. The likelihood of developing the condition increases with age. For women, the condition is more likely after menopause.
Sleep apnea is more common among people with thick or large necks. The condition is also more common among people who have smaller airways in their noses, throats, or mouths. The small airway could be related to the actual size and shape of the airway, or to obstructions or other medical conditions that are causing obstructions.
"I could align both CVOT / AQLAIM yet I don't think Seth would bring this up if the chances were less than 90%."
"In connection with the attendance of VIVUS, Inc., or the Company, at the 13 th Annual Needham Healthcare Conference, the Company will be distributing and presenting the slides attached hereto as Exhibit 99."
From VVUS Apr 8, 2014 Presentation
VVUS Strategy is creat interim analysis CVOT so that two years of data may be used to support an application while trial continues.
Satisfy FDA post-approval requirments with a single CVOT ( AQCLAIM/OB-401) that may also support EU registration.
1. Dialog with scientifict advice working party ( SWAP) - COMPLETED.
2. Revised OB-401 Protocol UNDER REVIEW AT FDA.
Qsymia CVOT, known as AQCLAIM is runing by almost 24 months.
VVUS CEO is very focus on his strategy ... CEO gaves investors some update where the company is standing and the company future action. this is very nice and should raise investors confidance .
"VIVUS plans to discuss with U.S. regulatory authorities and key consultants potential cost-saving alternatives with respect to the Qsymia CVOT, known as AQCLAIM. The Company is also in the process of pursuing approval for Qsymia in the EU and other key countries, as well as new indications in other chronic diseases such as obstructive sleep apnea (OSA) and type 2 diabetes. VIVUS plans to optimize spending while pursuing these potential objectives.
You are 100% correct !
CEO is leading VVUS in the right direction.
I strongly believe Qsymia sells to increase while expenses to decrease already in Q2.
Moving into digital media to promote Qsymia should be more appropiate to create awareness and finaly to increase sells. The effectiveness of promoting Qsymia by digital media to potential users will be much better compare salespersons calling on doctors.
The demand should come from the private to the doctors therefore communication with the private should be VVUS first priority to introduce Qsymia. once the privates be aware of the product they will call their doctor to try the product. No doubt Digital media ( the internet ) is the right place to invest for promoting Qsymia and get awareness.
I strongly believe that within 6 monthsI we will see some big change with Q scrip.
Could be nice progress....
Sentiment: Strong Buy
I strongly believe the CEO is leading VVUS in the right way.
Only few investros ... how long this play to continue ?
Have you ask yourself how much money OREX / ARNA is getting for every product their partner sell ?
From the latest IMS numbers although 150 VVUS sell reps Qsymia TRX & NRX numbers are not so far from her competitors with 600-900 sells reps ...
Once competitors to reach TR x & NR x at 50,000 -100,000 level then
VVUS to be open for partner talks.
Let the competitors create the market for VVUS.
Pfizer , Sanofi ENDO will call VVUS within 18 months.
First stage :
1. Going to ENDP CEO and tell him to make $100 million Stendra TV- campaign for aggressively promotion.
2. Asking ENDP for free sumples for one months.
Stendra should be $300 - $400 million product revenue within 3 years in the USA.
Second Stage :
Insurance insurance insurance is all about. focus on insurance companies.
They should put Qusymia ob tier II the same as CVS has done.
Sentiment: Strong Buy
I know you are long time VVUS stock holder.
You know how big the market expectation from Qusymia was and how the FDA took a stance for long term safety data ( CVOT trial ).
Qysima is a very good product but as Seth said the problem with physician and the health insurance companies. once this solves then you see the numbers growing.
Seth is looking 3-5 years forward... then the obesity market to be development the same as Actavis, Teva and all the others thinking.
Seth does not want to 100% finance Qysima like OREX / Arna and their partners. Seth know Qysimia long term value.
Do not expect much from Qysimia this year, I believe if selling product increase 15% on 2015 Seth will be pleased.
Regarding Stendra, Endo should go with national T.V campaign if they want a blockbuster product. The Women who most buying ED products for their sex partner have to know about Stendra advantages and not the men.
Sentiment: Strong Buy
What can he do more?
His people are working under his strategy.
Calling for physicians, speeking with potential companies to license Stendra for other territories. calling insurance companies to cover Stendra.
When the market see increasing product selling the stock price will go up.
at the meantime algo trading is running the stock up an down on a 4 - 12 cent.
Sentiment: Strong Buy