Replies to post #3062 on AVANIR PHARMACEUTICALS (AVNR)

[$to©k_Pi©ker™]

The company did not even state forecasts yet.

I have not been following bios more than 6 months, and i can already see how transparent this guy is already. He makes it so obvious. AF needs to go. What a sham.

[TH_Stockhunter]

U.S. FDA approves Avanir involuntary emotion drug
Published: Friday, 29 Oct 2010 | 6:58 PM

NEW YORK, Oct 29 (Reuters) - U.S. health regulators on Friday approved Avanir Pharmaceuticals Inc's Zenvia, a treatment for a neurological disorder in which patients cannot control outbursts of crying or laughter. U.S. Food and Drug Administration spokeswoman Sandy Walsh said the agency had approved the long-delayed drug. Zenvia is the first drug approved for the treatment of the little known, but not that rare, condition called pseudobulbar affect (PBA), which is also known as involuntary emotional expression disorder. Analysts expect Zenvia to garner peak U.S. sales of $350 million to $500 million ,and Avanir shares rose 15 percent in light after-hours trading on Friday. The approval could make Avanir an attractive acquisition target for larger companies desperate for new products that don't carry the risk of FDA rejection faced by promising experimental medicines. PBA affects an estimated two million Americans suffering from multiple sclerosis, Lou Gehrig's disease (ALS), stroke and other neurological disorders or trauma that can cause brain lesions. Avanir suffered a major blow four years ago, when the FDA rejected Zenvia and asked for new trials due to safety concerns. The FDA was uneasy about the heart rhythm impact of quinidine, a component of the drug used to increase the amount of the active ingredient, dextromethorphan, in the body. The agency asked Avanir to go back and perform new trials with only a third as much quinidine -- 10 milligrams instead of 30 mg. In August of 2009, Avanir said its reformulated Zenvia met the main goal of the new pivotal study by significantly reducing the emotional outbursts tied to PBA . The FDA accepted the resubmission of Avanir's marketing application in May, paving the way for Friday's approval. Many investors may have been betting on another delay as Avanir shares fell nearly 14 percent to $2.42 on Nasdaq before the FDA announced the approval. Avanir shares rose to $2.79 in light extended trading. (Reporting by Krishnakali Sengupta and Shravya Jain in Bangalore; additional reporting by Bill Berkrot in New York and Susan Heavey in Washington; editing by Carol Bishopric)

[Cobraman]

Nice try, but Adam already updated his post by adding the counterbalancing bullish view calling for more than 10 times thast amount of sales. The bullish view came feom a known analyst - not some anonymous source.

[io_io]

Feuerstein’s $50M number might be closer than the company’s own forecasts.

Dew, long time no speak...... look I realise that your fund may have been short this one, as you dont have much respect for small biotechs.

But in this case AVNR not only got approved, they got approved without a black box, so AF's concerns about safety were a load of, well, 'GTCB' if you know what I mean.

And what is more, AVNR's approval is so BROAD, the legal market is literally millions of patients - MS, ALS, Alzheimers and Stroke.

Take a look at this national Stroke Association survey:

http://www.stroke.org/site/DocServer/NSA_PBA_SurveyRelease1010.pdf?docID=8061

Survey results demonstrated that of the total National Stroke Association respondents, over half (304 of 578 respondents) had symptoms of PBA.

“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


These numbers make for a huge potential market. Even if the survey is off by a mile, it is a 1m patient market in stroke alone. And it is not off-label, meaning that the insurers must pay.

Dew .... I hate to tell you this, but if I were in your shoes I would cover first thing..... forget that it ever happened.

[damoney]

If you follow dipsticks "AF" advice we can assume you are burned and therefore should call AVNR for some samples of their product for Monday; you'll need them.
Oh, one more thing. I'm gonna make an obscene amount of $$ in the coming days. Lol