HGSI. The point is that I remain skeptic about yesterday panel's decision: I repeat, that vote of confidence seems to be forced, to much pression from public opinion, patients (the real victims, nd I hope the real beneficiaries!!!), markets and advocates groups, other lobbies. I'm not a physician or reumatologist, but how is it possible adfirm that no statistical deaths or suicides here? Too much votes for safety and effectiveness when we all know that data are a little uncertain, so I remain with serious doubts. Not very long term efficacy, only for a year, a year and half, may be enough for lupus patients to live better. But not the miracle drug all saying. Anyway no on better than fda may decide wisely about this.
Imho Fda will approve,but with enormous black box warning at least, it means that if approved, benlysta will be strictly monitored, I hope no failure in the post marketing approval phase, consequences will be the retirement from market. Fda will follow up this with much attention.
I don't understand the GSK specualtion about buyout, not surely in 2011 or 2012. They will wait to see how sales go, infact they don't fear nothjing at this point, if drug approved, they will pocket 50% of gross profits, not 10%!!! So why to risk 7/8 billion acquisition when Benlysta isn't yet approved, and HGSI's Zalbin failed in september. They will earn considerably by benlysta' sales interests, if drug shows effective safety and efficacy they mau buy out HGSI, but not now. IMHO.
