Replies to post #104211 on Biotech Values

[jq1234]

So you believe it shouldn't be approved or used for migraine? Is migraine a more serious condition than morbid obesity in your view?

Here is my view before Qnexa panel, so it is not Monday night quarterbacking:

Very complete and objective analysis. Even though I agree with most of your analysis, I’d give 40-60. Even if approved, it would be with very restricted REMS.

I don’t agree with this comment in your article regarding CNS:

” I wouldn’t want to be sitting in their shoes, because if they are forced to decide against Qnexa it might lead to some serious questions from patients already taking topiramate for migraines. Some that may crop up is: Why is it approved for headaches but not obese people when obesity is a much more serious and life threatening problem? If it were me at the FDA I woudn’t be able to answer that without lying through my teeth.”

There is big difference between migraines and obesity. For migraines, it is episodal use for short period of time; for obesity, it is continual use for long period of time. The safety profile requirement for these two different usages are different. Thus if losing weight were to happen in short period of time by taking Qnexa, it would be approved with current safety profile. However, to have to take for years make the safety profile with too many questions.

http://www.gekkowire.com/?p=4109