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  #1  
Old 07-10-2012, 04:37 PM
Anonymous
 
Posts: n/a
Banghead Qsymia No Product

Qnexa is now Qsymia. The first 14 names submitted to the FDA were rejected. Vivus has manufacturing issues. No supply and faulty process will only get product out for the first two months. On top of that a challenging REMS. It's too bad. Good people, bad decision.
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  #2  
Old 07-10-2012, 10:16 PM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

So wait are you saying that you don't think the obesity drug will get approved on july 17th?
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  #3  
Old 07-11-2012, 04:25 PM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

Quote:
Originally Posted by Anonymous View Post
Qnexa is now Qsymia. The first 14 names submitted to the FDA were rejected. Vivus has manufacturing issues. No supply and faulty process will only get product out for the first two months. On top of that a challenging REMS. It's too bad. Good people, bad decision.
Source:
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  #4  
Old 07-11-2012, 07:56 PM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

This position was brought to my attention by a friend. I'm currently in pharma, but looking to transition out over the next year or two. The base salary for this job is actually less than what I make. Seems like more of a risk than anything. And as anyone knows that has a clue....this gig is only as good as your manager and your drugs managed care position. Managed care will dictate what happens with this drug. The position pays 70,000 to the best of my knowledge. Bonus will be a crap shoot if you ask me. I guess if you have nothing to begin with...then this is a no brainer. Any thoughts from others in the same situation?
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  #5  
Old 07-12-2012, 11:52 AM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

I'm out of work so I'd love to be able to just go back to work.
I would take the job.
However, I didn't know about this drug or if they even had a sales team until recently.

I heard PDI is hiring the sales force but I guess i'm a lot too late to apply.
I went onto their website and applied for what was available.

I'm very frustrated in not being able to work. However, I do think
there is a lot of potential with this drug and obesity market.

I wish I had a contact to get in.

I do think the drug will be approved on July 17th do you think so?
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  #6  
Old 07-12-2012, 02:35 PM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

It will be approved. But supply is very limited. Not the way to LAUNCH.
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  #7  
Old 07-12-2012, 02:57 PM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

thank you very much.

One last question or opinion.
I have been out of work for quit some time "meaning in the pharma world"
like a couple of years. Only because i can not land a job.

I've tried with everyone "meaning companies, networking" etc..
But it seems like the industry is changing. I'm competing against other
unemployed, downsizing, etc..

A part of me just feels like giving up on looking within the industry but
then I do get excited about some great drugs that are out or coming out to sell.

What do you think? Find another industry or just keep looking.

I wish I had a way in for this drug

Thank you for your time.
I'm just so frustrated
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  #8  
Old 07-13-2012, 09:21 PM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

I would look elsewhere outside of pharma. Especially if you have been in this business for over 15 years. They don't want our type anymore. they want young, dumb, impressionable, mold-able, dopes that will march exactly the way that they want them to march. Get out of the business and do something that you actually feel good about. this business has been good to me, but it's time to go and do something full filling. In the end, the shareholders don't care about you. We are reusable trash. best of luck and follow your heart.
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  #9  
Old 07-16-2012, 11:34 AM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

Thank you so much for your advice.
I truly appreciate it.

Seriously...
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  #10  
Old 07-16-2012, 04:58 PM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

This drug will not be approved. Vivus heard earlier today. To all those who stood beside them. Thank you.
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  #11  
Old 07-16-2012, 06:47 PM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

Are you serious?

Why? Oh no!! I had a lot of stock put into this..

I really thought for sure it would get approved..

Oh shit!!

If they heard earlier today, why didn't they announce it
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  #12  
Old 07-16-2012, 06:48 PM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

Are you serious?

Why? Oh no!! I had a lot of stock put into this..

I really thought for sure it would get approved..

Oh shit!!

If they heard earlier today, why didn't they announce it

How come it wasn't on the news?
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  #13  
Old 07-16-2012, 08:47 PM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

I so hope you are telling the truth.

I just called my stock broker and had him sell
my stock first thing in the morning based upon
your thread message.

I'm tempted to invest in arena pharmaceuticals at this point as their stock may soar
due to vivus not getting approved per your thread.

You know you either saved me or sunked me..
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  #14  
Old 07-17-2012, 02:56 PM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

whoever this person is that stated the product was not approved..

where did you go? i'm wanting answers..

i moved my shares of stock out of vivus due to what you said...

hellow...
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  #15  
Old 07-17-2012, 04:03 PM
Anonymous
 
Posts: n/a
Grumble Re: Qsymia No Product

I see the drug trolls are out and about.
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  #16  
Old 07-17-2012, 04:34 PM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

will the drug be approved
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  #17  
Old 07-17-2012, 04:47 PM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

Quote:
Originally Posted by Anonymous View Post
will the drug be approved
CNBC just reported the drug is unlikely to be approved!
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  #18  
Old 07-17-2012, 04:54 PM
Anonymous
 
Posts: n/a
Unhappy Re: Qsymia No Product

Quote:
Originally Posted by Anonymous View Post
CNBC just reported the drug is unlikely to be approved!
Heard the same thing...they were speculating, but they are usually very accurate.
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  #19  
Old 07-17-2012, 05:05 PM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

WOW! I didn't hear that...thank you...i missed it on t.v.
i'm going to see if i can pull it up on the internet..

if i see or hear of anything else i'll post it..

thanks you guys

xo
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  #20  
Old 07-17-2012, 05:16 PM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

Evidently,

There was a report in the USA Today that reported the drug as approved but was then removed.

The story was removed from USA Today's website about an hour later and replaced by a statement that the story had been prepared "in anticipation of FDA approval, but at this hour that approval is still pending."

Being that it is at the end of the day and no word makes me Leary that the drug may not be approved..

This is so nerve wracking
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  #21  
Old 07-17-2012, 05:25 PM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

Just remember the advisory committe voted 20 to 2 in favor of approval and ARNA was only 18 for approval and the FDA approved their drug with less efficacy that qsymia.
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  #22  
Old 07-17-2012, 05:31 PM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

Quote:
Originally Posted by Anonymous View Post
Just remember the advisory committe voted 20 to 2 in favor of approval and ARNA was only 18 for approval and the FDA approved their drug with less efficacy that qsymia.
But didn't ARNA's drug have a better safety profile?
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  #23  
Old 07-17-2012, 05:34 PM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

Quote:
Originally Posted by Anonymous View Post
But didn't ARNA's drug have a better safety profile?
Yes and no. The cancer data is inconclusive which is why lorcaserin is recommended for short term use.
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  #24  
Old 07-17-2012, 06:08 PM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

I wonder why the decision was not announced by the end of the day today?

That makes me nervous in the sense of maybe something went wrong
because if were okay it would've been approved.
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  #25  
Old 07-17-2012, 07:47 PM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

WHOEVER THE PERSON ABOVE THAT SAID THE DRUG WAS NOT GOING TO BE APPROVED
I'D LIKE TO RING THEM BY THEIR NECK!!!!

HOW DARE THEY PLAY A NASTY PRANKSTER ON HERE LIKE THAT WHERE PEOPLE'S MONEY ARE CONCERNED..

KHARMA THAT'S ALL I HAVE TO SAY

YOU FUCKING LOSER
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  #26  
Old 07-17-2012, 07:59 PM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

Quote:
Originally Posted by Anonymous View Post
WHOEVER THE PERSON ABOVE THAT SAID THE DRUG WAS NOT GOING TO BE APPROVED
I'D LIKE TO RING THEM BY THEIR NECK!!!!

HOW DARE THEY PLAY A NASTY PRANKSTER ON HERE LIKE THAT WHERE PEOPLE'S MONEY ARE CONCERNED..

KHARMA THAT'S ALL I HAVE TO SAY

YOU FUCKING LOSER
why are you basing your financial decisions on a post on cafepharma? Most of what is on here is a lie. Most of the people who comment on here have nothing better to do.
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  #27  
Old 07-17-2012, 08:37 PM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

I knew it was a lie when I read it, but the poster said that he/she had already moved their shares so I didn't post a comment yesterday. What was done, was done. This person has been in my thoughts all day because I had a strong feeling the drug would be approved. I feel awful for you. I had my interview today and both managers were cool as a cucumber, they had no doubts. What a lying douche bag...truly evil. I do believe there is some valuable info on CP, but you have to have great discernment sometimes to rule out fact from fiction. Stock with a start-up company is scary, which is probably why the poster reacted so quickly with their shares.
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  #28  
Old 07-17-2012, 09:05 PM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

i hope that bonehead sold out based on an anonymous post. I hope qysmia is a smash hit.
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  #29  
Old 07-17-2012, 09:11 PM
Anonymous
 
Posts: n/a
Crying Re: Qsymia No Product

Wow..and the hate and jealousy go on. Tsk..tsk
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  #30  
Old 07-17-2012, 09:48 PM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

Wow did you see the label.

Pregnancy test to start and monthly, as bad as Accutane restrictions
Specialty Mail Order Pharma.....

And the warnings and precautions...
This is going to be a bitch to sell.

----------------WARNINGS AND PRECAUTIONS---------------------
• Fetal Toxicity: Females of reproductive potential: Obtain negative
pregnancy test before treatment and monthly thereafter; use
effective contraception. Qsymia is available through a limited
program under a Risk Evaluation and Mitigation Strategy (REMS)
(5.1).
• Increase in Heart Rate: Monitor heart rate in all patients, especially
those with cardiac or cerebrovascular disease (5.2).
• Suicidal Behavior and Ideation: Monitor for depression or suicidal
thoughts. Discontinue Qysmia if symptoms develop (5.3).
• Acute Myopia and Secondary Angle Closure Glaucoma:
Discontinue Qsymia (5.4).
• Mood and Sleep Disorders: Consider dose reduction or withdrawal
for clinically significant or persistent symptoms (5.5).
• Cognitive Impairment: May cause disturbances in attention or
memory. Caution patients about operating automobiles or
hazardous machinery when starting treatment (5.6).
• Metabolic Acidosis: Measure electrolytes before/during treatment
(5.7).
• Elevated Creatinine: Measure creatinine before/during treatment
(5.8).
• Use of Antidiabetic Medications: Weight loss may cause
hypoglycemia. Measure serum glucose before/during treatment
(5.9).


Overdose is not going to be pretty either.

Acute overdose of phentermine may be associated with restlessness, tremor, hyperreflexia, rapid respiration, confusion, aggressiveness, hallucinations, and panic states. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include arrhythmia, hypertension or hypotension, and circulatory collapse.
Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Fatal poisoning usually terminates in convulsions and coma. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. A severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia.
Management of acute phentermine intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. Acidification of the urine increases phentermine excretion. Intravenous phentolamine (Regitine®,CIBA) has been suggested for possible acute, severe hypertension, if this complicates phentermine overdosage.
Topiramate overdose has resulted in severe metabolic acidosis. Other signs and symptoms include convulsions, drowsiness, speech disturbance, blurred vision, diplopia, mentation impaired, lethargy, abnormal coordination, stupor, hypotension, abdominal pain, agitation, dizziness, and depression. The clinical consequences were not severe in most cases, but deaths have been reported after poly-drug overdoses involving gram amounts of
topiramate. A patient who ingested a dose between 96 and 110 g topiramate was admitted to hospital with coma lasting 20 to 24 hours followed by full recovery after 3 to 4 days.
Activated charcoal has been shown to adsorb topiramate in vitro. Hemodialysis is an effective means of removing topiramate from the body
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  #31  
Old 07-17-2012, 10:17 PM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

good lord people ~ just read both the PI's for phentermine and topiramate.........each PI individually is not benign. topamax = do your homework, used for both migraine and adult and peds as an anticonvulsant. phentermine = enough said, it has a history. but find me ONE successful weight loss guru who doesn't use phentermine in their weight loss cocktail and i'll give you my first born.

topiramate alone as prophylaxis for migraine has a HUGE weight loss side effect. of course an anticonvulsant is going to have baggage.............
will the benefit outweigh the risk? if it's dosed properly, hopfully yes.

if you go in thinking ONLY about the side effect profile, you're in the wrong industry. learn to sell or go to consumer goods.
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  #32  
Old 07-17-2012, 10:44 PM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

Yeah there are some issues with qysmia it would seem. the cleft lip thing is scary for prego moms.
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  #33  
Old 07-17-2012, 11:08 PM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

Quote:
Originally Posted by Anonymous View Post
good lord people ~ just read both the PI's for phentermine and topiramate.........each PI individually is not benign. topamax = do your homework, used for both migraine and adult and peds as an anticonvulsant. phentermine = enough said, it has a history. but find me ONE successful weight loss guru who doesn't use phentermine in their weight loss cocktail and i'll give you my first born.

topiramate alone as prophylaxis for migraine has a HUGE weight loss side effect. of course an anticonvulsant is going to have baggage.............
will the benefit outweigh the risk? if it's dosed properly, hopfully yes.

if you go in thinking ONLY about the side effect profile, you're in the wrong industry. learn to sell or go to consumer goods.
Yeah really who reads the label anyways.
IMS data is all that really matters
And the 10 post approval trials requested by the FDA well they won't care if we do them or not you can sell through that one as well.

Good luck.
Follow the track of your CEO and sell all the shares you can while the stock price is still in the double digits.
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  #34  
Old 07-18-2012, 08:43 AM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

the cleft palate is a warning for many anticonvulsants, that is nothing new for a topiramate label
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  #35  
Old 08-15-2012, 02:50 AM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

The two drugs are bot generic. Why would a doctor write this crap. Topamax used off lable seven yea,rs you genus lol
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  #36  
Old 08-15-2012, 07:22 AM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

Quote:
Originally Posted by Anonymous View Post
The two drugs are bot generic. Why would a doctor write this crap. Topamax used off lable seven yea,rs you genus lol
They will write because of the top notch contract sales force the Vivus managers put together. haha! Patients will pay 150.00 for this when they can get the two generics for 10.00, good luck sales team.
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  #37  
Old 08-15-2012, 04:12 PM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

let chat after one quarter of prescription data - folks pay WAY more than $150 for weight watchers/Jenny Craig/whatever. This drug has efficacy never seen before. And the market is huge and untreated.
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  #38  
Old 08-15-2012, 04:23 PM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

Quote:
Originally Posted by Anonymous View Post
let chat after one quarter of prescription data - folks pay WAY more than $150 for weight watchers/Jenny Craig/whatever. This drug has efficacy never seen before. And the market is huge and untreated.
But you don't need a dr to stick his neck out and prescribe Jenny Craig. There will be a market for this product but much smaller one than you think. The Vivus drug for ED would be a much easier sell. 10% weight loss is not efficacy never seen before, trust me!
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  #39  
Old 08-15-2012, 10:04 PM
Anonymous
 
Posts: n/a
Smile Re: Qsymia No Product

You are an idiot, the risks of doing nothing are great when you are really obese. 10% is good, do you have something better Einstein?
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  #40  
Old 08-15-2012, 10:43 PM
Anonymous
 
Posts: n/a
Smile Re: Qsymia No Product

You are an idiot, the risks of doing nothing are great when you are really obese. 10% is good, do you have something better Einstein?
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  #41  
Old 08-16-2012, 07:31 AM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

Quote:
Originally Posted by Anonymous View Post
You are an idiot, the risks of doing nothing are great when you are really obese. 10% is good, do you have something better Einstein?
Come back here when the first quarter results are in and you will realize that it will be time to get your resume back out.
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  #42  
Old 08-16-2012, 12:06 PM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

its a date! see you in Jan
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  #43  
Old 08-17-2012, 04:05 PM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

Did any of you see the headline today on two generics vs. this drug? Wow, good luck. There will be a lot of pressure for a short lived contract.
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  #44  
Old 08-17-2012, 04:58 PM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

the docs will be scared of writing generics with a category X and rems - they will protect their own asses.
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  #45  
Old 08-17-2012, 05:17 PM
Anonymous
 
Posts: n/a
Default Re: Qsymia No Product

Quote:
Originally Posted by Anonymous View Post
the docs will be scared of writing generics with a category X and rems - they will protect their own asses.
Drink some more Kool-Aid. Docs aren't afraid of writing generics, escpecially when they are proven to work as effective as a drug not covered by insurance....and patients are going to pay cash when they can get it generic. Not to mention pharmacist will try to switch to generic so they will make more money on the scripts. No brainer!
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  #46  
Old 08-17-2012, 05:57 PM
Anonymous
 
Posts: n/a
Default Thathas to sting just a little....

VIVUS tumbles after firm says doctors may replace company's drug with generics
Anti-obesity drug maker VIVUS (VVUS) is sinking after research firm Jefferies downgraded the stock to Underperform from Hold based on its belief that doctors may prescribe two generic drugs instead of VIVUS's product. in a note to investors earlier today, Jefferies stated that VIVUS's anti-obesity drug, Qsymia, is a combination of two generic drugs, topiramate and phentermine. Since insurers are unlikely to cover Qsymia, doctors will have a strong incentive to prescribe the two generic drugs instead, the firm argues. While VIVUS contends that doctors will be reluctant to prescribe the generic pills for an off-label use, i.e. obesity treatment, due to liability concerns, Jefferies, after studying the matter, said it's "increasingly skeptical" about this argument. Finally, the firm, noting that VIVUS itself used the two generic pills during a proof of concept study, says data suggests that there's no material difference between the effectiveness of VIVUS' Qsymia and the two generic drugs. Jefferies reduced its estimate for peak Qsymia sales to $1.2B from $3.6B and slashed its target on the shares to $16 from $31. In early trading, VIVUS tumbled $1.51, or 6.63%, to $21.25.
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