有没人持有avnr?该股公司要破产了？

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Friday, August 21, 2009
AVNR - Buy?
AVNR does not line up very well with my spreadsheet's TA signals, but it is a stock that I'd like to own a few years out.

Insiders own a lot of the outstanding stock. Institutions are buyers. Recently they put out their Phase III success, and jumped to over $4 in a single day. We know what happens then, euphoria, sell offs...the usual boom/bust cycle of human behavior.

The spreadsheet shows you where they are now. Here's some DD brought to you by a message board poster who loves this stock:

"Not only did it show efficacy at the 30/10 and the 20/10 trials, but there were practically no patients with SAE (serious adverse effect) related to the drug, Zenvia. The minor adverse effects were dizziness (19% and 11% for Zenvia 30/10 and 20/10 respectively versus 6% in the placebo group), nausea (13% and 8% versus 9% for placebo) and diarrhea (10% and 14% versus 7% for placebo).

As for patients who discontinued the study: that was not related to the drug (8% and 18% versus 14% for placebo) I suspect that it was Zenvia's efficacy that was responsibl3e for the low discontinuation for the 30/10 group.

As for thr QT prolongation issue, that is no longer an issue. Avanir reported no cardiovascular side effects. On page 23 of (the study) the prolongation was 3.0 msec and -1.9 msec versus 1.5 msec for placebo. So it seems that if you measure the QT after 84 days, we see that the QT prolongation of 10.5 msec, seen earlier, can somehow auto-correct itself (cf homeostasis) after 84 days. SO THE QT PROLONGATION IS NOT AN ISSUE ANYMORE.

As for the 7 deaths, well, the study had 197 ALS patients who are suppose to die within 2-5 years after diagnosis. So according to published epidemological data, we expect 4-6% of the ALS patients to die irrespective of the drug. What we do see is 4.6%(3) and 4.4%(3) versus 1.6%(1) for the placebo. So what this tells us is that the placebo was a FLUKE. It may be because that the patients in the 30/10 and 20/10 groups had more advanced ALS (avg. 23 months, avg, 16.3 months versus 13.4 months for placebo). So, as you can see, statistically, we may see patients in the 30/10 wing start to die within 1 month into the study, just because of the underlying ALS, and irrespective of Zenvia treatment. cf,, page 6 of (the study) 6 of the 7 deaths were reported as not related to treatment. Most likely because the deaths occurred after 5 days of treatment cessation. There was only 1 death in the 20/10 group that MAY be treatment- related.

But overall, the STAR trial was a huge success for AVNR. There was no serious adverse effects and no cardiovascular side effects (because the QT prolongation is NOT an issue when you measure after 84 days). The deaths in the Zenvia trial wings were on the low side of what was expected for ALS patients. And the one death that MAY be treatment related--Well, we have to put things into perspective: these ALS patients are people who are living the last 2-5 years of their life. I would give them a drug that would make them happier, more sane and with more self-respect, even if it means that 1 out of 200 people who take the drug MAY die. Remember: they are scheduled to die anyways. At the absolute very worse, the FDA may approve for MS, Alzheimer's, Parkinson and brain injury, but they MAY not approve it for ALS patients. But that is the worse case scenario."

The message board argues over the one person whose death may or may not have been related to the test drug, Zenvia, of the terminally ill patients suffering from ALDS, in the test group. They also argue over the amount of income this drug can bring. The proponent suggests:

"I like the Zenvia product that is coming out for PBA patients, which Avanir has researched to be 2 million people just in the USA alone. So, it can potentially be a $4 billion market, based on Avanir's pricing plan of $2000/per year per patient. And I do think that 100% market penetration can and will be achieved with PBA because i) it is a very devastating condition on the patient's mental health, and it also forces the patient to withdraw from society--both friends and family, ii) the targetted patient's are patient's with an underlying neurolgoic condition, so we can know that they will already be under a drug plan, and that they will be seeing a physician (neurologist) regularly, and iii) these neurologists will surely hear about PBA and Zenvia at the conferences they go to or read about it in medical magazines, and/or Avanir's seasoned sales force will be able to inform them."

Opponents suggest less, likening it to aspirin and different models of pricing, lower appeal, smaller overall market, and lower market share.

The AVNR webpage has their press releases and powerpoints, providing the investor with enough information to make up their own mind, but as we've seen from message boards, they are not interested in making up their own mind....they want to make up your mind.

The spreadsheet says that enough people are trapped at over $2, to make a very supportive bottom, and so I bought the dip, as I mentioned yesterday. When it trades above a sell signal, this time I will. It's that easy.
Labels: AVNR

posted by BxCapricorn at 5:29 AM