Replies to post #98907 on Biotech Values

[DewDiligence]

Obesity Drugs: What I Would Do If It Were Up to Me

I would request a randomized head-to-head study lasting three years of the obesity drug in question vs Allergan’s LapBand procedure.

Any drug that achieved non-inferiority to LapBand in cumulative weight loss and CV-related morbidity/mortality would be deemed worthy of approval. I would allow a wide non-inferiority margin because LapBand is a very good product.

JMHO, FWIW

[biomaven0]

I agree the Loraceserin safety data is good, but there is still the concern that the AC might want to see data on combination therapy with phentermine (because the drugs are invariably going to be used together) and also might want to see a safety study combined with SSRIs (SSRIs were excluded from the Arena studies). The issue with SSR's arises because of possible concern with serotonin syndrome - any time you have multiple drugs touching serotonin the possibility of the syndrome is of concern.

I ended up buying a little bit of ARNA after the NEJM article - I sold them on today's pop.

The VVUS drug is not dead in my view - the 2-year safety data comes out next quarter, and if the data is good that might well be enough to tilt the FDA.

Peter