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Replies to #83374 on Biotech Values
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genisi

09/09/09 2:07 PM

#83378 RE: turtlepower #83374

VVUS - Safety certainly looks acceptable but why would docs use
onexa brand when they can use the two generic components? perhaps if onexa is priced low enough.
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iwfal

09/09/09 11:04 PM

#83405 RE: turtlepower #83374

VVUS and Qnexa safety -

I'm not too familiar with the drug but I believe it contains two ingredients which individually cause serious side effects.



Had to relook at the safety data to regather my facts (I looked at this and dismissed it because I considered the likely ph iii pop fairly low because the trial results were too obvious - that the real pop would come with FDA approval, which was much more of a wild card.)

Phentermine might have a bad rep as part of fen-phen, but it is fairly well accepted that by itself it doesn't have the PAH et al issues. (and note that fen-phen didn't have Qt problems)

And topiramate's 'only' SAE are suicidal thoughts (especially upon quiting) and kidney stones.

So altogether the Qt data is expected. The lack of suicidal thoughts is perhaps at least somewhat reassuring, but even the pessimistic case would have perhaps 4 suicidal thoughts patients (label for top says 1 in 500) in 2000 treated patients. Not likely to be even noticed in a trial this small. So again a mostly expected result.

C'est la vie.

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genisi

09/10/09 5:44 AM

#83407 RE: turtlepower #83374

VVUS - did they release anything about what happened to their subjects after discontinuation of the drug taking? I wonder if there are long-term effects.