Replies to post #98793 on Biotech Values

[DewDiligence]

I’m with you on VVUS, FWIW.

[biomaven0]

"The incidence of depression-related adverse events in the PHEN/TPM clinical trials was 3.4% in the placebo group, 5.0% in the low-dose PHEN/TPM group, 3.8% in the mid-dose PHEN/TPM group, and 7.7% in the high-dose PHEN/TPM group." This was never mentioned in their presentation.

So mid-dose is indistinguishable from placebo. High-dose is a possible signal.

When assessed as a group, the incidence of
cognitive-related adverse events was 1.7%, 2.0%, 5.6%, and 7.8% in the placebo, low-dose, mid-dose, and high-dose PHEN/TPM groups, respectively. The most common adverse event related to cognitive dysfunction was disturbance in attention.

These are all reversible immediately on stopping. So if the patient finds the cognitive effects a problem, they stop the drug.

"Approximately 30% of individuals treated with high-dose PHEN/TPM experienced a serum bicarbonate <21 mEq/L compared to 5.9% of individuals treated with placebo.

That's a known side effect of Topamax. The FDA didn't see that as an obstacle for migraine prophylaxis, so I don't see that as a show stopper.

"A higher proportion of PHEN/TPM-treated individuals experienced a categorical increase in heart rate compared to placebo treated individuals (>20 bpm: 19.6% high-dose PHEN/TPM versus 11.9% placebo)"

That's a known effect of the phentermine. Meridia has the same effect. But that will be a subject of discussion at the AC. Offsetting this is the reduction in BP and lipid improvement.

I still think the pregnancy issue will be the dominant area of discussion, followed by cardiac. Clearly this is not a super-clean drug, but I think on balance the AC will be favorable.

Peter

[DewDiligence]

Nice call, Tony, on VVUS (eom).

[EZ2]

Knowing VVUS offering now not approved......is that a potential vote of confidence for ARNA's product ie. reportedly the "best of breed" related to side effects, etc. ?

With obesity at such high levels and 'propaganda' flying on it ------ would FDA be remise in not finding at least ONE of the products permissable ?

Once VVUS details are out, I'd appreciate hearing your perspective on FDA's rationale.

Thx!