It's so unfortunate for those of you that bought NBIX on bad info. Pivestment keeps telling you one point of view without you all having a good countpoint out there that knows the pharma industry well.
I firmly believe that you can not buy based upon one person's anonomous writings. You NEED to do your own research. There are always two sides to a story. But I also think someone should not act like they know everything and spread misinformation when so much is at stake. Some of you bought and sold based on one guys' info and that is just stupid. This forum is for healthy debate, not idolizing anonomous gods.
1. Insomnia market is not currently growing at 20% per year, may in the future due to increasing number of elderly in this counrty (that is why eldery data with Indiplon is so important and FDA wants Neurocrine to look again at it even with the IR formulation) - I would like to know your source on this 20% figure you keep repeating.
2. Even top scientists admit they do not know the significance of selectivity to GABA A receptors - are you telling me you do? All you can do is look at the clinical trials - including # of patients, setup, exclusion criteria, primary and secondary endpoints, results, p vaules (how significant it is compared to placebo), and side effects. A MOA(mechanism of action) of a drug is just an MOA, the clinical significance is the important part - especially to the physicians prescribing a drug.
Also you can not directly compare two different clinical trials - it is like comparing apples to oranges. Doctors look at SEPRATION FROM PLACEBO when evaluating efficacy and side effects. Saying Lunesta had 17% headache in one study vs Indiplon only having 10% in another means nothing. Can not compare the two - different patient population and study. One of Lunesta's studies showed NO sepration from placebo in terms of headache-try to sell Indiplon vs Lunesta to a doctor of a headache side effects and Pfizer will eat the little Indiplon sales force for lunch.
let me get your opinion on a few things - I know that you enjoy the technical research side of these meds
do you agree with the analysts assessment that the indiplon IR market is only limited to the sonata market despite the clear evidence that indiplon is faster acting - 170X more slective for the a1 receptor than sonata, and 30X more specific than sonata for the a1 receptor
I have been trying to pound this into a few think skulls
that type of comparative analysis is strongly suggestive of the idea that indiplon IR will be much more effective and with less side effects than sonata - and thus it can gain a much larger market share
I have shared the views of some of my friends from medical school who are practicing internists or PCP's - they are afraid to give older patients knock out pills because of the fear of accidents ( which they might be considered to be negligent for considering the known side effect profile of knock out pills ( lunesta , ambien CR) and thus they would love to have an effective short acting agent - sonata is a short acting agent - but it is not that effective and has a poor relative side effect profile
your comments? can you see my point on why the IR market is much larger than the sonata sized market analysts see?
thus even with IR alone and NBIX owning 96.5% of it they have a real jewel on their hands
Wow! I really hope you are not saying giving 100mg of Lunesta to a rat equivalats in any way to a very large human being taking 3mg of Lunesta. Also this study said further investigation is needed with these extremely high doses of Lunesta, but no conclusions were drawn.
Zopiclone is not Lunesta, but zopiclone is the most prescribed sleep medication in the world. Are you saying all of these patients are going to die of cancer.
I would love to see which Neurocrine or Pfizer researcher put this little pearl into publiction. Notice what it leaves out - there were lower doses in the rat study but there was not increased mutations at those doses.
Just wait until the approved labeling of Indiplon comes out, if ever. According to pinvestment it is only going to be 2 sentances long and would look something like this:
Indiplon is the best insomnia drug ever discovered. Because of selectivity Indiplon has the best efficacy and side effect profile possible.
You are correct. Zopiclone is 1/2 Lunesta but at a higher dose with 7.5 mg zopiclone.
Again, Zopiclone 7.5 mg = 3.75 mg Lunesta + 3.75 of other isomer.
Lunesta is only approved in US at 3mg. That extra .75 mg is very significant when you look at the data.
For example 2mg of Lunesta only has a sleep onset indication, but 3 mg of Lunesta has a sleep maintenance indication in addition. Every study has show a significant difference between 2 & 3 mg Lunesta in terms of efficacy and side effects.
An extra .75mg of Lunesta is very significant and can not be discounted. There is a reason Neurocrine used zopiclone in their studies instead of Lunesta - they are trying to scew the data in their favor.
About the cancer thing pin tries to throw around. Look at Lunesta PI - not found to cause any problems. The FDA in the US is much more strict than European countries. If there was even a hint of problem, they would not have approved Lunesta, or at very least the label would have a warning.
Backed into acorner and resorting to scare tactics now pinvestment???
you wrote previous that doctors look at separation from placebo - that is hogwash - when you talk to a doctor you should not explain to them how doctors think
i have plenty of colleagues from my medical school and residency days that i can talk with about these topics
one of the most common answers i get is that it seems there is a building reticent to use the longer acting drugs on older patients for fear of putting them at risk
please also consider that PK studies are done in healthy young patients - and that as patients age the clearance of a drug can drop in a rather large manner
OK, so what do doctors use to evaluate the efficacy and safety of a drug? Nature Articles? I would love to hear your answer.
I agree with the clearance of a drug in older adults and so does the FDA. That is why Indiplon needs to be reevaluated in the elderly population even in the low doses.
Lunest has the two longest trials in the over 65 population of any drug on the market. And you are right, they showed using a lower dose - 2mg instead of 3mg. With no doseage adjustment needed for anyone with mild,moderate, or severe renal impairment or even mild or moderate hepatic impairment.
This is a very key population moving into the next decades and it looks like the FDA is concerned about the Indiplon data.
//you also don't seem to understand that PFE needs blockbusters to stay alive - if indiplon got 25% of the insomnia market that would be 1 billion in sales and around 16$ per share in pre-tax profits//<br><br>Why would PFE walk away from a billion dollar drug? Why would they walk away from ANY profit? You seem to know a lot about the drug--but not as much as PFE--and they walked away.
you might want to go back and re-read some of my posts from friday
PFE has 5400 reps in 9 division - thus one PFE division only has 600 reps - not that much bigger than NBIXs 200
you also don't seem to understand that PFE needs blockbusters to stay alive - if indiplon got 25% of the insomnia market that would be 1 billion in sales and around 16$ per share in pre-tax profits
====PFE has 5400 reps in 9 division - thus one PFE division only has 600 reps - not that much bigger than NBIXs 200
Nice try, you are off on the # of reps by 100s of percent. Got the # of divisions wrong too.
That fact alone renders the rest of your "analysis" pure, unadulterated garbage.
the idea that the insomnia market is not growing at 20% is kind of stupid
i grabbed the first one i could find but any simple search of research reports shows the growth of the insomnia market to be growing rapidly
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Market for sleeping disorders forecast to triple to $11 billion by 2012
March 13th, 2006
The current market for drugs to treat sleep-wake disorders is estimated at US$4.3 billion and is forecast to increase by 158% to US$6.6 billion by 2012, says a new market report available from Piribo, the online destination for business intelligence for the biotech and pharmaceutical industry.
This "estimated and projected" data is for 2012. Give me some concrete numbers. 20% per year is a huge increase and would anout to more than 158% increase by 2012.
The data for this year shows a slight increase in the insomnia market but news about Ambien side effects has hurt the entire market. The projected data for this year included the forcast that Pfizer would start marketing Indiplon by mid year and increase the buzz around the market. That is not going to happen as we know.
Let's count how many things pinfraud did wrong here:
* first he plagiarized from a newsrx.com headline and posted it here without attributions to pretend those arose from his own research
* when confronted, then he reveals the sources
* and the sources then indicate he
1) can't read + can't do math
2) lied purposely
The headline plainly stated it encompasses all sleep-wake disorders such as "insomnia, excessive daytime sleepiness, shift-work sleep disorder, sleep apnea, and restless legs syndrome."
So pin the jackass pretends all other sleep-wake illnesses don't exist and says insomnia market is growing 20%.
AND sleep-wake disorders--which includes insomnia is forecasted to grow 158% till 2012. That's LESS THAN 10% a year EVEN INCLUDING OTHER DISORDERS.
Of course there are 4 things in life you can count on
3. pinvestment posting "facts" he pulled out of his ass
4. IQ-deficient sheep recommending pinvestment's posts
another excerpt from the previous nature article
this goes toward what i consider to be the low hanging fruit of the insomnia market - patients that cannot take ambien or it doesn't work for
I believe selectivity of indiplon leads to less side effects - and potentcy of binding the gaba a1 receptor can lead to higher efficacy
Although efficacy is on par with the benzodiazepines, Ambien is less likely to disturb sleep architecture, and cause cognitive and psychomotor side effects, and can be discontinued without withdrawal problems. A low incidence of next-day effects on memory and attention can be attributed to a short half-life, but this is a double-edged sword: one study demonstrated that 30% of Ambien users could not sleep through the night while on the drug. Therefore, despite Ambien's success, there is a significant market opportunity for a longer-acting, more selective sedative.
how about an excerpt from a nice nature review article
i imagine you will think that a peer reviewed article in nature must be full of sh*t
sounds like they agree with my view on advantages
Like Ambien and Lunesta, Pfizer/Neurocrine's indiplon is a non-benzodiazepine GABAA agonist. However, it has some competitive advantages that could make it the drug of choice in the insomnia market. First, indiplon binds the GABAA receptor with ten times greater strength than that of Ambien, and therefore has a fast onset of action and can be dosed at much lower level, which reduces the risk of side effects. Second, it is rapidly absorbed and has a short half-life, which allowed Neurocrine to develop both immediate-release (capsule) and modified-release (tablet) forms that, together, could address the spectrum of insomnia manifestations. The capsule would be useful for patients experiencing difficulty falling asleep or for those who awaken unexpectedly during the night, and the tablet would be most appropriate for those patients who have both sleep-onset and -maintenance issues.
Pin , I read only your post. Who ever you are responding to I simply put them on ignore. That saves me time searching for your post. I also do a search for your name under authors below in the search engine given for this board. I was in Peru during the latest down tick in NBIX. I was not un easy at all. I read your post and this week will buy more. This is a rediculously low valuation of NBIX. I am happy for the chance to buy now.
I think hedge funds are a danger to our stock market. Unregulated to the point of illegal. Its a shame and thorn in the markets side. It brings pink sheet games into the bigger markets. I wish our senators would get off their duffs and make them illegal. They are destroying a once fair market. I believe they are the main reason for NBIX's distorted current price. The only good things are that they create huge bargains to the market. The problem is that it takes people like you to understand and point out the true facts.
Keep posting my friend. You are doing a honorable service to the common investor. The bashers here are evil and will burn in more than one way for their lies.
OK lets talk more about this selectivity you keep touting. You say 10 times more selectivity thatn Ambien and not 10 times more side effects?
Ambien is currently the most selective to GABA A 1 of any of the drugs on the market. This is why Ambien is the only non-benzo on the market that shows a significant separation from placebo with regards to hallucinations and sleep wlaking/eating/driving (amnestic events) in their studies. This is not a class effect, if you are a physician, contact an Ambien medical liason and they will tell you this is not a class effect. An Ambien rep may try to tell you different but they have no proof.
Again, referring to my previous posts. MOA means NOTHING. What the GABA A receptors do and selectivity with the drugs is far beyond the understanding of science at this point. The brain is a very complex organ.
The only thing we know for sure is the clinical data during clinicla trails. That is why separation from placebo is so important.
due you doubt the early mutagenesis and increased cases of cancer in patients that have taken zopiclone?
do you understand that mutagenic drugs have an accumulative effect over time and that it is possible for the mutagenic tendencies of zopiclone to potentially cause serious problems over time
Stebbing J, Waters L, Davies L, Mandalia S, Nelson M, Gazzard B, Bower M. Related Articles, Links
Incidence of cancer in individuals receiving chronic zopiclone or eszopiclone requires prospective study.
J Clin Oncol. 2005 Nov 1;23(31):8134-6. No abstract available.