Biotech Values

[biomaven0]

two Qnexa patients that had heart attacks

No imbalance in mortality in trials totaling around 6,000 patients - and remember there were about twice as many Qnexa patients as placebo patients, so really an excess of a single heart attack.

As opposed to that, there is a significant decrease in progression to type II diabetes - 1.9% instead of 4.5%, aside from the overall significant reduction in Hba1c and reduction in blood pressure (9mm systolic) amid a reduction in antihypertensives.

high rate of non-responders

Why is this a problem? If no response by 3 months they will stop the drug. Ditto for the people (like me) that do not tolerate topiramate - they will stop fairly quickly.

On balance, these safety and efficacy results suggest to me that you will kill far more people by delaying approval than by approving the drug. Likely we'll have to wait for a long-term Phase IV to see if I am correct or not.

Peter