panel on 11/16 has 7 out of 15 are Lupus experts.

people speculate with panel favor, pps will be in range lower 30s; with FDA approval, pps will be higher 30s to lower 40s. But with acquisition, pps could be higher 40s to lower 50s in the year 2011.

Many people on Yahoo board have Jan2012 calls also.

 

copied from one personal blog posted today:

"The **Voting** Question #6

“Do the efficacy and safety data provide substantial evidence to support approval of belimumab at a dose of 10 mg/kg at 2-week interval for the first 3 doses and at 4week intervals thereafter demonstrated substantial evidence of efficacy for reducing disease activity in adult patients with active, autoantibody-positive, systemic lupus erythematosus who are receiving standard therapy?”

"Given that there has not been an approved treatment for SLE for 50 years, I think the panel is going to be hard pressed to vote against the drug. I also think that there isn’t much more data the company can provide to soothe the FDA’s concerns on the risks outlined, they have data for some 5 years. The company may have to provide a detailed analysis of the suicide risk, but I honestly think they will want to address this post marketing and the FDA seems to lean this way in the way they ask the 3rd question in the B.D.’s. I also think the safety profile for the drug is strong and that the real issue here is whether or not the efficacy data is strong enough to let the drug through. I think the panel will probably vote in favor of letting the drug through because at 52 weeks the drug does prove efficacy, even with the problems in the North American study. I also think the vote may be more mixed on question 4 where the FDA asks about efficacy, but still positive.

****Panel****

So the Panel makeup is usually key to estimating how the FDA will vote. By my count we have 15 voting panel members. From what I can see there are none of the usual critics that try to hijack the panel hearing for political purposes (I’m talking about Dr. Sidney Wolfe who works for Public Citizen) and skew it unfavorable for the drug companies because of their political agenda. What I do see is a strongly favorable make-up of the panel for Benlysta. The panel consists of one expert that I think will seriously want to discuss the depression and suicide risk issue (Robert Kerns). The FDA has concluded that they don’t know the risks, but I think they may be leaning towards addressing this post marketing, especially since anti depressants (a commonly taken drug) contain a black box warning for suicides."

"What I do see is a panel made up of 7 experts that deal with SLE on a regular basis and are more likely to view the drug as a step ahead. They are: David Blumenthal, Kathleen O’NeilMatthew Lang, R. John Looney, Christy Sandborg, Maria E. Suarex, and David Pisteky. So I theoritcally could attribute 7 votes as being a yes already since in the past I have noticed experts in a field are more likely to go along with a drug because it is another tool for them to use."

"Now, we also have a Kathleen Arntsen that represents the Lupus Foundation and I would naturally count her as a yes vote as well. So I can tally a total of 8 votes leaning towards approval. I’ll put an estimate of a vote for Question #6 at 13 to 10 votes in favor for approval and a possible 2 to 5 in favor of non-approval."