kahuna

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    • Mon Oct 13th 13:40 PM | Rating: 0 0
      Commented on:
      Cinryze Approved: A Significant Catalyst for Viropharma, Lev Pharmaceuticals
      You didn't mention an important factor; that is CSL Behring has it's version of Cinryze (C1INH) in the FDA's pipeline and has an expectation of approval (most likely for the acute indication) early next year.

      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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    • Sat Jul 19th 22:39 PM | Rating: 0 0
      Commented on:
      Lev Acquisition Looks Good but More Clarity Needed
      This acqusition seems to be done the wrong way. That is, wouldn't you expect the drug license be granted before shopping the company and a takeover deal is announced to maximize shareholder equity?
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    • Thu May 15th 20:21 PM | Rating: 0 0
      Commented on:
      Lev Pharmaceutical: Bullish, Despite Delayed FDA Decision
      On May 2nd a meeting of the FDA's Blood Products Advisory Committee recommended--in a stunning 21-0 vote--that the FDA approve the Lev Pharma C1 inhibitor product for "preventing" HAE attacks. The HAE Association (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.
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    • Mon Mar 17th 19:07 PM | Rating: 0 0
      Commented on:
      Lev Pharmaceutical: Bullish, Despite Delayed FDA Decision
      Have two family members that have HAE and both have had access to Cinryse. This medicine works 10x10 to provide mitigation for HAE related symptoms and it provides relief within 30 minutes. To an HAE patient it is a miracle drug.. and no patient receiving this medicine has reported any adverse effects. Licensing this medicine should be a “no brainer” for the FDA.
      View article »
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