Alright folks lets do this. Have you ever noticed your broker crying all the time? Has the decade-long battle with 10,000 DOW left you with Pseudobulbar Affect? If so I have the stock for you. AVANIR! No not Avitar! AVNR. This baby bio has combined two drugs and formulated a third. This is always suspect can't folks just mix up their own batches? yes and no. The fact is 1 mil folks have this uncontrollable laughter and or crying and only half of them are employed on wall street. >Pseudobulbar affect (PBA) or labile affect or more informally emotional incontinence refers to a neurologic disorder characterized by involuntary crying or uncontrollable episodes of crying and/or laughing, or other emotional displays. PBA occurs secondary to neurologic disease or brain injury. Patients may find themselves crying uncontrollably at something that is only moderately sad (NYG losing), being unable to stop themselves for several minutes. Episodes may also be mood-incongruent: a patient might laugh uncontrollably when angry or frustrated, for example any daytrader. The AVNR story goes back to 20006 when they got fast tracked for Zenvia their treatment for PBA. The FDA rasied some concerns- this was based on the dose of Zenvia that contained 60mg of quinidine one of the two compounds that make up Zenvia. The original therepudic dose was closer to 30mg and this test screwed the co. At lower doses no bad side effects that would stop FDA approval were spotted. Anyway skip forwards and a major new trial the new Zenvia would have 30mg of dextromethorphan and only 10mg of quinidine-- gone went any cardiac risk. Ok so the new trial of Zenvia 30/10 dose had almost a 47% reduction above and beyond placebo and the Zenvia 20/10 dose having almost a 50% incremental reduction above and beyond placebo with both achieving strong statistical significance. By the 5th dosing, Zenvia treatment arm had an 88% reduction in episodes vs. baseline. So what we have is a drug that's a shoe in. It's formed from two known compounds and it was getting the mix down that mattered. We have a production facility ready to roll that the company has contracted with big European one can't remember the name. They have 1200 or so resumes for a salesforce; all they need now is the FDA ok. And here in comes the timing- Oct 30 action Date***** You get 55 business days beforehand when the FDA may request a special talk... that time passes as of today or tomorrow. So we have a straight on bet for Oct 30 a stock at $3.00. The market I see as big because many diseases jump into this PBA and there are some pain relief associated with Zevia which by the way cannot be called Zenvia! The FDA has told them that the first part " Zen " means well being and was too promotional... Well at least it shows the company is talking with the FDA all the time. AVP-923 (temp name) will be priced at $3,000 to $5,000 a year with unlimited year over year use. the patent is very secure and long 15 years. Co has $41 mil cash and a burn rate of $16 mil per 9 months Well it's a bet on now till Oct 30 how high will Avanir climb in anticipation of approval? $5? Then what after $7 and $10.... that last one is Jeffries price target. 3,500 AVNR @ $3.10. ~stoney
Here is a great pump piece from Seeking Alpha if it doesn't get you fired up nothing will. You have to know how to use Seeking A or you will get burned. But when all the facts are as you see them and you happen to agree and have been following the stock due to technical reasons why not buy. This position has an Oct 30 Explosion Date With history if nothing else it gives you something to hope for in the coming months and even if the markets go down the closer we get to this date the stock will hold and gravitate... http://seekingalpha.com/article/212...t-for-avanir-pharmaceuticals?source=thestreet 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.
UPDATE! for immediate release- dateline- I can't stop laughing and crying. The move into the decision date has finally begun we are at $3.30 and pointing north everyone is in at $3.00 area. The indications are that this will be a rocket ride. I just hope it's UP! Short Position is climbing UP 26% from sept 1! Over 10,000,000 shares are short now. If we roll them this stock will react oh so well. AVNR traded over 15 million shares between 8/31 & 9/15 (11 trading days) over a million shares a day! Sept 23rd for instance AVNR traded 3.7 mil.... And this while the stock began going UP... Could we get the ole' " quick cover " here when shorts are panicked out well before the big FDA day in Oct 30... I think so.~ stoney
$3.10- $3.40 we need much more. This is an absolute joke. You folks can get in while the getting's good. Common ETer's!!!!!! More coverage: Shares of Avanir (AVNR) traded higher this morning as Canaccord Genuity (the global capital markets division of Canaccord Financial) reiterated a âBuyâ rating and raised its price target from $6 to $9. According to their analysts: âRaising 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 AVNRâs 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.â
More Coverage! NO BARRIERS TO APPROVAL! - $10 PT! Posted on 10/12/10 at 9:36am 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, âWe 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.â
HA HA HA HA HA HA HA HA HA HA.... An October To remember brought to you by stoney! I've been laughing all morning! It was going to go one of two ways, laugh all day or cry all day. I did everything I could do on my part. (1) researched the company (2) charted the company (3) researched the drug and the trials (3) placed note under Buddha head. (4) I do a ritual with my computer in which I circle it and press yahoo finance but (this is important) DON"T look at the news... I press the symbols and then I clean the kitchen, make coffee and walk the dog, offer to take the kid to school... I try to give back the most I can before walking by the desk and just take a peek... what's that? FDA gives Halloween treat! YESSSSSSSSSSSSSSS. Folks on this one trade we have made $7,000 PROFIT! HA HA HA... I can't stop laughing, if it had gone the other way I'm just starting to realize that I would of lost that amount... I don't really want to know that... My nickname in the 80's was " Biotech Ben " and now you all know why. Well we have one more soldier we have to walk through the bloody FDA fields... and that's Delcath DCTH! HAPPY MONDAY EVERYONE! ~stoney
Ok. Now we have to put our sanity hats on. How big can the target population be for this little known disease? How bout this gem: National Stroke Association Survey Results: PBA impacts many survivors, but few understand condition Monday, October 18, 2010 By: Taryn Fort Press Release Download PDF version of this Press Release National Stroke Association Survey Reveals More Than Half of Stroke Survivors Suffer Added Burden of Little Known Neurologic Condition Pseudobulbar Affect Impacts Majority of Stroke Survivors, But Few Have Any Understanding of Condition CENTENNIAL, CO â October 18, 2010 â 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), Hummmmm. rumor: Avanir Pharma price target raised to $15 from $10 at Jefferies From a message baord: "Valuation In my valuation of the company, I will disregard the current royalties received from GlaxoSmithKline (GSK) on Abreva sales (approximately $3-$4 million expected this year) and will focus solely on Zenvia, which would be the first drug approved to treat PBA. Per Randall Kaye, Chief Medical Officer, the prescribed period of time on the drug would be "indefinite," not a 12-week limit. This translates into increased revenue potential. And the company has supporting data to prove efficacy and safety over time, as they have over 100 patients with over 2 years exposure to Zenvia. As mentioned above, Mike King of Wedbush compares the company to one that has a market cap of $1.5 billion. That number is above, but not far off from, my estimates. 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 plus potential value maximizing follow-on indications." Merriman analyst states, âThe companyâs 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 compellingâ¦â Letâs examine a price/sales multiple. Cantor Fitzgerald estimates $675 million in peak sales for Zenvia, ramping up and seeing those peak sales in 2015. Personally, I think the estimate is a bit conservative when one factors the indefinite prescribed period and the other applications of Zenvia that should be approved following the PBA approval. But, letâs go with Cantorâs sales estimate. Although there is wide variation in price/sales ratios, the average biotech trades at 3 times peak sales. Since Avanir has rights to the drug longer than most drug companies (15 years), it could reach much higher multiples. But, even using a more conservative estimate of half that figure (1.5 times price/sales), the market cap of Avanir should be over $1 billion. Thatâs approximately $10 per share, indeed compelling with a potential upside of over 400%! And for more short-minded investors, there are two near-term catalysts." Ladies and gentlemen, * 2 million patients * Indefinite prescriptions * Following up indications * Acquisition target/war Man, any price below $10 is a steal. Hummmmmm. Fols where is the cheer this morning!!! I know you all listened we put this out long ago my phone is ringing off the hook and it's broken.... Common.... ~stoney
PRICE TARGET CONFIRMED AND IT'S EVEN HIGHER-$15.00!!!! 06:52 EDT AVNR theflyonthewall.com: Avanir Pharma price target raised to $15 from $10 at Jefferies WHAT TO DO? Some help folks please..... Perhaps leave a sell order at $7.00????? I'm taking my kid to school, sparkle up and get my head straight and then I need to make the ever important sell or no sell decision.... ~si
congrats dude... I bought 80K shares on thursday and sold on friday AH for 192,000$. (20K$ more in the Bofa account, not posted). You were right that this had the best chance of approval. I had done my homework and agreed with you. http://img258.imageshack.us/img258/857/20101029etrade.jpg http://img218.imageshack.us/img218/2162/20101029avnrsells.jpg onto the next one. g