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Protalix BioTherapeutics, Inc. (PLX) Message Board

  • woodbarn woodbarn Oct 11, 2013 3:08 PM Flag

    Would Fabry drug qualify as FDA breakthrough?

    Would Fabry drug qualify as FDA breakthrough? A breakthrough is a substantial improvement over existing drugs. So PRX-102, Fabry drug, has half-life of 581 minutes versus existing enzymes with a 13 minute half-life. Longer half-life should allow enzyme to be absorbed by organs.

    How about oral Gaucher's drug for breakthrough? Can you think of any substantial clinical benefit over existing therapies? Maybe less immunogenicity?

    In the next 3 to 6 months Protalix finishing up pediatric study for Elelyso, finishing up Fabry phase 1 and 2, and finishing up oral Gaucher's enzyme phase 1. I think oral Gaucher's enzyme is the same as Elelyso, so maybe it can get quicker approval, assuming oral administration works.

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    • Exactly. A lot going on. Better Fabry drug with $700 million estimated market. Oral Gaucher drug would certainly be considered a breakthrough if you no longer had to go to an infusion center.
      I think the stock price is down for financial reasons (some dilution from $69 million convertible note sale). If the studies have good results and the pipeline and platform are properly valued, the stock is very cheap. Will be an interesting shareholder meeting in November. Management should have to answer why they are getting rich and the shareholders are losing money.

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