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FDA news

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Adding his voice, Jim Greenwood, president and chief executive of the Biotechnology Industry Organization (BIO), said: “BIO supports the PDUFA V recommendations as they will enhance the drug development and review process through increased transparency and scientific dialogue, advance regulatory science, and strengthen post-market surveillance. Most importantly, PDUFA V will provide patients and doctors with earlier access to breakthrough therapies.”
Mr Greenwood noted: “Unpredictability in the review process, suboptimal communication with sponsors, and decreased FDA performance not only hinders patient access to new treatments, but also negatively impacts the ability of biotechnology companies to raise funding to support clinical development and ongoing innovation. This undermines economic growth in the biotechnology sector as well as biomedical research into key public health priorities. In PDUFA V, industry and FDA have agreed upon a set of enhancements that seek to restore FDA’s review performance and get back-to-basics for patients by strengthening scientific dialogue and transparency between FDA and the sponsor during the review of a novel drug or biologic, with the goal of minimizing review issues that can delay patient access to needed treatments.”
https://www.reuters.com/article/2011/09/01/us-fda-pdufa-idUSTRE7806CZ20110901
I want to add that there is still a Immunology Panel Date listed for 12/1/11 on the FDA site. Don't think it will happen at that time but maybe they will still try to get it done before the end of this year.In my opinion this is unlikely but I would expect that the new date would be announced prior to that because they give the physicians a 3 month notice. Gen-Probe said the first quarter so I am looking towards mid-February. However, I do expect us to make a move towards the $1.50 point prior to year end and than $2.00 just before the panel votes. I am also looking forward to the earnings report this week and just maybe they will tip their hat on expectations. (I know like us, they must be very disappointed by the delay, but it gives them time to hit the streets and raise U.S. awareness of the company.) If we hit the $1.50 mark and up they will be at a point where they can list here in the States and we could see some nice things happen to the share price.