I liked the Martin Luther King holiday so much, I’m taking it off twice.
But since the stock market is open let me offer a least this much:
Suggested at $7.25 three months ago, VVUS was bouncing nicely above $11 last week until . . . oh, no!
Weltanschauungians had best not take it to the bank quite yet – even at Friday’s close of $8.74 we were still up 20% or so.
But Guru is nothing if not frustrated:
So VVUS met with the FDA. We all thought the main issues were resolved. Then some @#$ person at the FDA said they want Vivus to look at Johnson & Johnson’s data on the use of topiramate to prevent migraines to see what the incidence of cleft lip is. (WHAT does this have to do with obesity?)
The FDA knew that topiramate caused teratomas four years ago when they granted VVUS an SPA. There were no teratomas in VVUS trials. WHY are they obsessed with this now? Makes no sense.
I “believe” this will get resolved favorably – but when I am trying to model irrationality, I come up short on how to do it well. The sense is it will take another 6 months to complete this study, at which point I am guessing it is a 2 month review, but it is possible this exercise will stretch the approval for this already-approved drug to 2012.
☞ So if we ever do get a further run-up in the stock, Guru believes it will be some months delayed.