kahuna's Comments RSS Syndication from SeekingAlpha.com http://seekingalpha.comuser/164928/comments http://seekingalpha.com/article/99529-cinryze-approved-a-significant-catalyst-for-viropharma-lev-pharmaceuticals?source=feed#comment-281437 281437
Neither company actually developed this medicine; they merely tweaked a drug (to FDA standards) that has been available in Europe for years. Because of this, the FDA will likely allow these two companies to compete in the marketplace. The orphan drug statuses will likely have little meaning as physicians could use each for acute or prophylaxis as desired.
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Neither company actually developed this medicine; they merely tweaked a drug (to FDA standards) that has been available in Europe for years. Because of this, the FDA will likely allow these two companies to compete in the marketplace. The orphan drug statuses will likely have little meaning as physicians could use each for acute or prophylaxis as desired.
]]> http://seekingalpha.com/article/85434-lev-acquisition-looks-good-but-more-clarity-needed?source=feed#comment-209594 209594 Sat, 19 Jul 2008 22:39:03 -0400 http://seekingalpha.com/article/63789-lev-pharmaceutical-bullish-despite-delayed-fda-decision?source=feed#comment-168457 168457 haea.org) had a contingent of 5 patients and a physician who spoke before the Committee and the FDA staff. The speeches made by HAE patients had a remarkable impact on the proceedings. Afterwards the Committee began asking the FDA staff pointed questions about why treatment for attacks that are underway (acute attacks) was not being considered.
The Blood Products Advisory Committee's unanimous endorsement of licensing Cinryze in the United States is a huge win for Lev Pharma and HAE patients in the United States.
]]> Thu, 15 May 2008 20:21:37 -0400 haea.org) had a contingent of 5 patients and a physician who spoke before the Committee and the FDA staff. The speeches made by HAE patients had a remarkable impact on the proceedings. Afterwards the Committee began asking the FDA staff pointed questions about why treatment for attacks that are underway (acute attacks) was not being considered.
The Blood Products Advisory Committee's unanimous endorsement of licensing Cinryze in the United States is a huge win for Lev Pharma and HAE patients in the United States.
]]> http://seekingalpha.com/article/63789-lev-pharmaceutical-bullish-despite-delayed-fda-decision?source=feed#comment-127905 127905 Mon, 17 Mar 2008 19:07:09 -0400