i might have heard wrongly but isn't AVNR suppose to present
Nuedexta at some kind of event this week?

finally something positive for today

Nuedexta patent doesn't end till 2025!
15 years of patent and no competition
My opinion is this company will be a
very potential buyout target.


one thing i hope is that Avanir doesn't sell the drug
at a very high price so that more patient can afford it.
5k per year seems expensive 3-3.5k seems reasonable to me.

After everything that has happen I guess I am not
going to get the notorious scissors lock from my
wife by going all in!

Congratz all longs!

only manage to grab 1500 @ 1.87 after spending 3 minutes checking
news.




this is better than robbing a bank.
work in air condition.dress smartly.highly paid
and the best thing is government will help them when
you are in trouble using money from the people they rob.

this is interesting


October 28, 2010 10:31 AM EDT
Canaccord Genuity Morning Coffee on Avanir Pharma (Nasdaq: AVNR): Expecting a VERY HAPPY Halloween.

Canaccord Genuity Biotechnology Analyst Ritu Baral stated that investors should take advantage of Avanir share price weakness, and reiterated her bullish rating and target price on conviction of imminent FDA approval near the October 30 PDUFA. Baral estimates FDA approval chances for Avanir's AVP-923 for PBA at 75% based on extensive talks with experts and careful analysis of safety data. She thinks Avanir will drive strong PBA awareness and conduct a strong launch in Q1/11. Baral believes 923 will see good uptake starting H2/11. Baral highlighted that she still views all safety data including QTc data as clean, adding that she strongly believes pivotal STAR trial and thorough QTc data (e.g. mean, mean- max elongation, and categorical/outlier analysis) meet all FDA safety approval hurdles. Baral does not think FDA QTc concerns will delay approval. Additionally, Baral stated that she strongly believes STAR mortality data shows no drug-related deaths. There was a STAR trial deaths imbalance (six of the 923, one placebo; 2:1 randomization). However, all deaths were fragile ALS deaths, related to respiratory depression (not sudden cardiac death), and deemed by doctors to be related to ALS progression not 923. All ALS experts Baral consulted have FIRMLY dismissed drug involvement in the deaths. It must be noted that 923 is Avanir's main value driver, and serious FDA delay or safety issue would be very negative. Baral thinks Avanir may still trade up on a small labelling delay. If FDA requires additional clinical safety trials, Avanir could trade down close to cash.

link

26% of float shorted how many is that actually as i can
only see till 10/15/10 short interest in nasdaq website.
anyway this news is positive for longs when more money
will flow into avnr if it is approve.

short interest for 10/15/10 out.
still around 12 million shorted slightly decrease by 100k shares.

LOL the candle name sounds like a kung fu move in the movies.

i'm guessing that short interest have increase to 15 million
or more we will be able to know by next tues or wed.

double post.sorry

No gap up please.
Avnr has a habit of closing the gap
I would rather it open low and close high.

not sure about option but i think the share price have to
go above 3.95 to make a profit

linjeta is also a daily dose and if it is
approved shorts will lose more than their pants.

yup i totally agree with you there.

but the only problem is avp-923 is for pba not for diabetes

below is the company link.maybe u wanna read up on it
before being so sure that a crl is coming?

avp-923 is a pill not a needle

i notice he is not as bearish as his previous avnr article

compilation of analyst rating and comment for AVNR

Merriman Curhan Ford Initiates Coverage on Avanir Pharmaceuticals
(AVNR) with a Buy; Compelling Small-Cap

January 29, 2010 7:06 AM EST

Merriman Curhan Ford initiates coverage on Avanir Pharmaceuticals (Nasdaq: AVNR) with a Buy rating. Price target range of $4-7.

Merriman analyst says, "Avanir Pharmaceuticals is advancing its lead product, Zenvia, for the unique indication of pseudobulbar affect (PBA), a hitherto little-known neurological condition that may affect millions of individuals. The initial intent is for Avanir to advance Zenvia into the marketplace for PBA
patients secondary to multiple sclerosis and Alzheimer’s disease. The company’s market cap is significantly undervalued due to a previous regulatory delay and lack of knowledge of the PBA indication. In our view, the Phase III STAR trial data are compelling, and a response under an sNDA should be submitted during 1H10."
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Canaccord Adams Initiates Coverage on Avanir Pharmaceuticals (AVNR) with a Buy; Zenvia Approval Seen in 2010

April 6, 2010 12:43 PM EDT
Canaccord Adams initiates coverage on Avanir Pharmaceuticals (Nasdaq: AVNR) with a Buy rating. Price target $6.

Canaccord analyst says, "We believe that over 33% of ALS and MS patients with moderate PBA and over 50% of severe PBA patients with underlying ALS or MS would pursue treatment with Zenvia. We also think that over 50% of Parkinson’spatients with severe PBA will also choose to receive Zenvia, as well as a meaningful percentage of patients with other neurodegenerative disorders. We think that overall, this adds up to a potential 150,000 Zenvia patients, leading to a peak sales estimate of around $350 million.”
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Wedbush Initiates Coverage on Avanir Pharmaceuticals (AVNR) with an Outperform; You’re Not Verklempt, It May Be Your PBA

April 29, 2010 10:10 AM EDT
Wedbush initiates coverage on Avanir Pharmaceuticals (Nasdaq: AVNR) with an Outperform rating. PT $9.

Wedbush analyst says, "Avanir is currently an off-the-radar-screen company developing Zenvia, a late-stage asset for the treatment of pseudobulbar affect (PBA). PBA is itself a little-recognized, but serious and debilitating, disorder that typically is a consequence of any one of several neurologic insults, such as MS, ALS, or TBI...An investment in Avanir is reminiscent of the opportunity presented to investors when Fampridine-SR was in early development for Acorda (Nasdaq: ACOR) (Not Rated), which currently boasts a valuation of ~$1.5 billion."
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Canaccord Adams Maintains a 'Buy' on Avanir Pharmaceuticals (AVNR); Adds to Best Ideas List

May 4, 2010 11:08 AM EDT
Canaccord Adams maintains a 'Buy' rating on Avanir Pharmaceuticals (Nasdaq: AVNR), adds to Best Ideas list. PT $6.

Canaccord analyst says, "Positive, incremental Zenvia data, good doctor acceptance at AAN; doctor outreach to continue. AVNR had incremental Zenvia Phase 3 data and a commercial presence at April’s American Academy of Neurology (AAN) meeting. Doctors at AAN we spoke to were aware of PBA as a serious unmet condition. We think Zenvia data was well received at AAN and AVNR will continue with strong disease awareness and patient outreach programs prior to approval, to establish the PBA market...We think Zenvia year-end approval, Q1/11 launch will be key catalysts for AVNR. We think Zenvia will receive six-month FDA review, and be approved around the end of 2010. AAN doctor opinion on Zenvia has been positive; we think that Zenvia will see good patient and doctor acceptance and uptake starting in H2/11."
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Canaccord Adams Maintains a 'Buy' on Avanir Pharmaceuticals (AVNR); Zenvia PDUFA Date

May 18, 2010 11:16 AM EDT
Canaccord Adams maintains a 'Buy' on Avanir Pharmaceuticals (Nasdaq: AVNR), price target $6.

Canaccord analyst says, "We predict approval around end of 2010 and Q1/11 commercial launch. We note that, as AVNR management indicated, the new Zenvia approval package contains a very large amount of new clinical, non-clinical and CMC data. We would not be surprised if FDA took >6 months to approve the drug. However, we think any delay would be minor and not reflect negatively on Zenvia’s approvability or sales potential...We think Zenvia approval around year-end 2010 and Q1/11 launch would be key catalysts for AVNR."
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Canaccord Adams Maintains a 'Buy' on Avanir Pharmaceuticals (AVNR); APA Data Underscores Zenvia's Good Safety, Market Potential

May 25, 2010 11:21 AM EDT
Canaccord Adams maintains a 'Buy' on Avanir Pharmaceuticals (Nasdaq: AVNR), price target $6.

Canaccord analyst says, "Positive incremental Zenvia safety data at APA: mild ositive to negligible drug-drug interactions suggest large market opportunity. AVNR is developing Zenvia, a combotherapy dextramethorphan/quinidine now under FDA review for PBA (an emotional lability disorder seen with ALS, MS and other brain-wasting diseases). Last night, AVNR presented drug-drug interaction data at the American Psychiatric Association (APA) meeting (New Orleans) showing Zenvia could safely be used with a popular antidepressant (paroxetine) and a widely used Alzheimer’s drug."
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Cantor Fitzgerald Initiates Coverage on Avanir Pharmaceuticals (AVNR) with a Buy; Anticipate Zenvia 4Q:10 Approval

June 9, 2010 7:37 AM EDT
Cantor Fitzgerald initiates coverage on Avanir Pharmaceuticals, Inc. (Nasdaq: AVNR) with a Buy rating. Price target $8.

Cantor analyst says, "We think AVNR is significantly undervalued given its current market capitalization and near-term FDA approval potential for its lead product, Zenvia, to treat pseudobulbar affect (PBA) plus potential value maximizing follow-on indications."
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Jefferies & Co Initiates Coverage on AVANIR Pharmaceuticals (AVNR) with a Buy

July 1, 2010 8:14 AM EDT
Jefferies & Co initiates coverage on AVANIR Pharmaceuticals (Nasdaq: AVNR) with a Buy rating. PT $10.
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Canaccord Genuity Reiterates a 'Buy' on Avanir Pharmaceuticals (AVNR); 923 Approvability Underscored by More Safety Data at ANA

September 15, 2010 10:59 AM EDT

Canaccord Genuity reiterates a 'Buy' rating on Avanir Pharmaceuticals (Nasdaq: AVNR), price target $6.

Canaccord analyst says, "Reiterating rating and target on increasing confidence of approval, eiterating strong launch on additional safety and PBA QoL data at ANA...We think the NDA answers all FDA questions and 923 will be approved on or near the October 30, 2010 PDUFA date...Doc and disease advocate opinion on 923 safety and efficacy has been very positive; we think AVNR will continue to drive strong PBA awareness and conduct a strong 923 launch. We think 923 will see good acceptance and market uptake starting in H2/11."
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Canaccord Genuity Raises Price Target On Avanir Pharmaceuticals (AVNR) to $9


October 7, 2010 1:52 PM EDT
Canaccord Genuity reiterates a 'Buy' on Avanir Pharmaceuticals (Nasdaq: AVNR), raises PT from $6 to $9.

Canaccord analyst says, "...Raising target to $9 based on higher chances of FDA approval on Oct. 30 PDUFA, long-term commercial success. We raised our estimate of approval chances for AVNR’s lead drug AVP-923 for PBA from 60% to 75% based on extensive talks with experts and new safety detail. Expert opinion on 923 safety and efficacy has been very positive. We think AVNR will drive strong PBA awareness and conduct a strong launch in Q1/11. We think 923 will see good market uptake starting in H2/11."
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Canaccord Genuity Morning Coffee: Avanir Pharma (AVNR) Happy Halloween?

October 8, 2010 10:31 AM EDT
Canaccord Genuity Morning Coffee: Avanir Pharma (NASDAQ: AVNR) Happy Halloween?

Canaccord Genuity Biotechnology Analyst Ritu Baral upped her target price for Avanir shares on higher chances of FDA approval on October 30, and long-term commercial success. Baral raised her estimate of approval chances for Avanir’s lead drug AVP-923 for PBA from 60% to 75% based on extensive talks with experts and new safety detail. She highlights that Expert opinion on 923 safety and efficacy has been very positive. Baral thinks Avanir will drive strong PBA awareness and conduct a strong launch in Q1/11, and 923 will see good market uptake starting in H2/11. Neurologists who know 923 strongly believe FDA should and will approve it soon, Baral stated, adding that recently released safety data is very clean. She thinks labelling talks are ongoing, suggesting timely approval. Sources close to 923 and Avanir’s pre-marketing activity hint that FDA has given no suggestion of delay.
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Jefferies Reiterates Buy Rating on Avanir Pharma (AVNR)

Posted on 10/12/10 at 9:36am by Michael J. Zerinskas
Jefferies & Company is out with a research report this morning, where it reiterates its Buy rating on shares of Avanir Pharmaceuticals (NASDAQ: AVNR); it has a $10.00 price target on the stock.

The Jefferies analysts said that they believe management continues to have constructive back and forth rhetoric with the FDA and continue to expect approval for AVP-923 (formerly Zenvia) by October 29th.

They added that there appears no be no barriers to the FDA approving AVP-923, as all items highlighted under the SPA were addressed and the cut-off for the notification date of the FDA panel has passed.

As for valuation, the analysts remarked, “We arrive at our $10 PT by applying a 30x multiple to our 2013 EPS estimate of $0.78 and discounting back at 30% per annum.”

link

link

Very well done! Thank you pcrutch!

positive article for avnr long found in ymb

http://www.physorg.com/news/2010-10-survivors-added-burden-neurologic-condition.html

More than half of stroke survivors suffer added burden of little known neurologic condition

October 18, 2010
A survey released today by National Stroke Association shows that 53 percent of stroke survivor respondents suffer from symptoms of another neurologic condition called pseudobulbar affect (PBA), a condition thought to be caused by structural damage in the brain due to injury or disease. PBA causes involuntary and unpredictable outbursts of laughing or crying, often in socially inappropriate situations. Even though a significant proportion of stroke survivors suffer from PBA, fewer than one in five are familiar with the condition.

Survey results demonstrated that of the total National Stroke Association respondents, over half (304 of 578 respondents) had symptoms of PBA as determined by a score of 13 or greater on the Center for Neurologic Study Lability Scale (CNS-LS), the standard, self-report tool used to assess the presence and severity of PBA symptoms. Of these respondents, approximately 27 percent had CNS-LS scores that indicated moderate-to-severe symptoms of PBA. More than one-quarter (27%) indicated that they experience PBA outbursts frequently or often.
In addition to the potential prevalence of PBA among stroke survivors, the results illustrated the negative effect on quality of life that PBA has on stroke survivors and their caregivers. About four in 10 respondents reported that PBA episodes interfere with their social activities including spending time with friends and family. Likewise, about one-third of the respondents indicate that PBA episodes have contributed to difficulty in maintaining relationships or becoming housebound.
"With more than SIX MILLION stroke survivors in the United States, the prevalence and burden of pseudobulbar affect in the stroke community is significant," said James Baranski, CEO, National Stroke Association. "Not only are these survivors recovering from a serious neurologic injury, but they are also dealing with the anxiety, embarrassment and social isolation that results from PBA episodes – all at a time when support from family and friends is needed most."
Other key findings from the National Stroke Association survey include:
More than 50 percent of stroke survivors with PBA symptoms consider the episodes of involuntary crying and laughter to be burdensome.
PBA interferes extremely, very or somewhat often with everyday activities such as spending time with friends and family (38%), talking on the phone (32%), interacting with nurses or other healthcare professionals (24%), and attending church or religious services (23%).
Only about a third of those with PBA symptoms are treated for their episodes (38%), and only half of treated patients are satisfied with their treatment.
Other involuntary emotional episodes frequently experienced include frustration, irritability, agitation and anger.
"The results of the National Stroke Association survey on PBA confirm what I see on a regular basis in my practice as it pertains to stroke survivors," said Richard Zorowitz, MD, Chief, Department of Physical Medicine and Rehabilitation, Johns Hopkins Bayview Medical Center. "This survey demonstrates that PBA is a common condition that stroke survivors must also manage. It can cause significant impairment in patients' and caregivers' quality of life. The findings also reinforce the need for effective treatment options that help patients reduce the involuntary outbursts of laughing or crying and allow them to regain more control over their daily lives."
National Stroke Association conducted the survey in conjunction with Avanir Pharmaceuticals, Inc. to learn more about the prevalence and impact of PBA among stroke survivors and the level of awareness of the condition among both patients and their caregivers.
Provided by National Stroke Association

keep your cool guys.i think we will see what answer pcrutch have
receive from avnr on a article in biomedreports as he is working
there.it is his job to get the information publish there before
revealing it here in my opinion.

wanted to share some notes that i think is important to know about agitation i've taken when listening to Dr Zeller experience when treating agitation.

Treatment goals in emergency psychiatry:
-rapid stabilization
-avoid coercion (big issue in emergency psychiatry)

2/3 of staff injury due to trying to restrain patients *i assume that its to give a IM/IV to patients*

Dr Zeller has two concussion due to head injuries cause by agitated patients during his career in emergency psychiatry.(it's more scary and more urgent than what most people have pictured in their mind.Dr Zeller likened it to a patient having a cardiac arrest sent to a ER.)

Most of treatment today *i assuming it's oral med* takes too long too work .the faster it work the less chance someone will get hurt.

Don't want patient to be over sedated or the doctors can't help them.

long term side effect not a consideration in emergency psychiatry as it is mostly a one time medication

Oral medication
benefit:well studied,known efficacy
limitation:takes too long too work *remember its a emergency*

IM/IV
benefit: faster onset of action
limitation:
-over sedation
-coercive
-interferes with therapeutic alliance
-risk for injuries*i assume it's the staff trying to restrain pts*
-usually know pts out cold while sometimes may not solving the agitation

Goals of ideal agitation treatment:
-reduce dangerous behaviors,anguish and hyperactivity
-intervene prior to violence
-rapid tranquilization
-minimize need of physical restrain
-treat without over sedation
-treat while creating therapeutic alliance(most patient have no trust in doctors when they are being force to be injected)
-ease of administration.


some info might be incorrect since i was taking the note in a rush.

Gekkowire just came out with a share price estimate.


Judging from his past estimate style and alxa estimate i think
this guy have a agenda to push alxa share price down.

The timing for the copd and asthma trial and how he 'found' it.

The continuance attack on the lung issue without stating that
there is no serious or severe respiratory adverse events.

Now many message board there is discussion about lung damage.

Let's think about it for a second.On 11/09/09 when the filing was
publish where the trial result came out if it is that bad or devastating do you think the share price will not tank when so many funds and banks with their analysts waiting for every single opportunity to go short or long in the market?

az-004 is not perfect it has it's risk and benefit but after listening to the conference call for the feburary analysts day
(it's 3hrs long omg!)where Dr Zeller describe the situation in the
ER and what the current standard of care can do for them i believe az-004 should be approve for the benefit for the
patients,doctors,nurses and patient family.

Don't be greedy!!!



Just give me 250% profit and i will be contented. LOL

got some more at 3.03

The filing that gekkowire is talking about.

Alexza completed a Phase 1 placebo-controlled study in 53 subjects with predominantly moderate-to-severe COPD and a Phase 1 placebo-controlled study in 52 subjects with mild-to-moderate persistent asthma, to assess the pulmonary safety of AZ-004 in these populations. The studies employed double-blind, parallel-group designs. In each study, subjects were given two doses of Staccato placebo or 10 mg AZ-004, ten hours apart. Spirometry testing and other safety assessments were performed at several time points up to 24 hours after the second dose. The primary safety measure was FEV1 (forced expiratory volume in one second), a standard test of lung function. Decreases in FEV1 versus baseline, respiratory symptoms, and use of a quick-relief bronchodilator occurred in both treatment groups, but were more frequent in each study after treatment with AZ-004. There were no serious or severe respiratory adverse events. All respiratory symptoms developing after treatment were either self-limiting or readily managed with the inhaled bronchodilator.

the author seems very bearish about alxa for bullish argument
he points out the data most people know but for bearish argument
he makes extra effort to imagine scenario that FDA will use to
disapprove the drug.hopefully he did not do it purposely but one
thing i'm sure the stock tank because of that article.

holding 30% thru decision date for me.

Hold the line Alex!!! Hold the 3.20 line!!!
Protect your shareholder! Flank the shorts left and right!!!

in my opinion the sell off is due to many investor playing the run up exiting the position seeing the chart doesn't look too good now.

come on alxa make me a happy man again big fat green candle tomorrow please!!!

i wish u could see the silly smile on my face! LMAO

hope it has hit the bottom today and continue the upward
momentum.

alxa share price for the past week makes me feel like inhaling a
AZ-004 during trade time and a AZ-007 during sleep time. :)

i will be a very happy man if it close green today! lol

agreed.my sentiment is that it will rise fast and hard this week or the next

NEW YORK (Market Intellisearch) -- ALXA options saw interesting call activity today. A total of 16 put and 1,886 call contracts were traded raising a low Put/Call volume alert. Today's traded Put/Call ratio is 0.01. There were 117.88 calls traded for each put contract.

Put/Call ratio is often used to measure investment sentiment, the ratio serves as a predictor of investor behavior. Unusual options volume provides reliable clues that the stock is expected to make a move.

Alexza Pharmaceuticals closed at $3.53 in the last trading session and opened today at $3.56. The stock price declined $0.06 (-1.70%) to $3.47 in today's trading session. ALXA is trading between the range of $3.44 - $3.59. Volume is 468,149 in relation to the three month average volume of 675,972 shares. The technical momentum Relative Strengh Index indicator shows overbought conditions. ALXA is trading above the 50 day moving average and higher than the 200 day moving average. The stock's 52 week low is $1.93 and 52 week high is $3.92.

We most probably will see a good day today after previous week slaughter.

i don't know if i'm correct but from my observation these few days
it seems that mm is holding this stock down.

for example when it is trading between 2.66-2.67 u can see all those 100 shares trading but it always register the lower prices even though 2.67 are trading too and when retail investor buy(1000-2000 shares)they always have to bid at the higher range because no one is really selling except those 100 shares trading and the mm quickly bid the pps down again with those 100 shares.it is only when retail investor are frustrated with the trading range that they sell at a lower price.

others stocks i observe there is also this type of manipulation but for avnr it happen every second of the whole trading day.

i can't explain very well but hope u all can understand.

barefootrunner- I tried to google but to no avail earlier on.
Thanks for explaining!

I am a bit worried about the confidential filing though.
Any thoughts?

From yahoo msg board

"There likely won't be a PR regarding approval of the facility until the PDUFA date. The CRL, if there is one, will contain that information along with other issues"

"Because the FDA usually states its issues it has- which includes the manufacturing facilty- with the new drug application near the pdufa date and thats when the company will find out. Until then, we as investors will not know. This is the same for every biotech with an NDA- including others right now like AVNR, BIOD, ARNA, etc. Nothing has changed with the process as far as I know."

i think it is quite true but not very sure that we won't get a pr
for the facility inspection