FDA Briefing Docs Are Up, So Are Stock Prices

The FDA briefing documents are up.  Have a read.  They are over 300 pages, so allow some time.

Clearly, many agree with me that FDA raised no new concerns about VVUS today, and that this is good for OREX as well.  The shares of VVUS, OREX and ARNA are all well up.

Don't be surprised if Qnexa ends up with a category X counterindication for use in pregnancy though. Lots of data around this in the documents.  Interestingly, both topiramate for epilepsy and phentermine are the milder Category C: use in pregnancy only if benefits to mom (and, therefore, baby) clearly outweigh risks to baby.

Also, there are case histories included of the serious adverse events (AEs), and while there were not a lot of them, I note that despite the studies' having excluding bipolar patients, there still were a few AE's in the "going too far up" class (hallucinations, flight of ideas etc.)

Comments

[Biotech Stock Day Trader]

I have been watching the weight loss drugs with great interest leading up to the VVUS decision this week. I found a good analysis on OREX yesterday before all the price increases. It is posted at www.stocktipweekly.com with information about the 3 companies looking for FDA approval and why they think OREX will be the big winner.