Replies to post #107552 on Biotech Values

[mcbio]

I'm not familiar with AVNR at all but it seems to me that a decent number of the more regarded posters on this board would have concluded that this company was a sham based on this NYT article.

AVNR is definitely not a sham. In their prior days (when known as Lidak), they developed Abreva (known as Lidakol originally) for oral herpes and that's now on the market OTC, although they monetized all of their royalty rights I believe.

I'm surprised, given that the condition doesn't even have a proper name and the drug appears to have safety issues, that the FDA approved it.

Count me as surprised as well. When it was noted that there were a higher number of deaths in the Neudexta arm, I thought for sure the drug would be rejected. This just goes to show the unpredictability of FDA decisions and it's why I almost always try to avoid them (and Phase 3 results).

[jq1234]

I am not surprised you drew your conclusion because the article isn't well written. This type of article misleads the general public.

The drug incudes low dose of dextromethorphan hydrobromide (20 mg), cough supressant, and quinidine sulfate (10 mg), a metabolic inhibitor enabling therapeutic dextromethorphan concentrations, which have been on the market for years if not decades.

FDA turned down original 30/30mg. AVNR did new study with 30/10mg, 20/10mg. This time, FDA approved only 20/10mg for ALS and MS. The label is pretty restrictive. I do question the market potential.

Here is a better article from Bloomberg:

http://www.businessweek.com/news/2010-10-29/avanir-drug-cleared-for-uncontrolled-laughing-crying.html