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Protalix BioTherapeutics, Inc. (PLX) Message Board

  • momentum74 momentum74 Feb 25, 2011 12:36 PM Flag

    Europeon and FDA approval for PLX in the coming months that is bullish imo.

    Good CC @ PLX

    A number of issues discussed on the call and I highlighted what for me was important.

    1) They have 35MM in cash 12/31/2011 that is sufficient for the next 12 months.

    2) Meeting with Pfizer management team to plan response strategy.

    3) No additional clinical studies requested.

    4) Manufacturing plant given FDA acceptance /approval.

    5) Have data that FDA is requesting but needs clarification.

    6) European Approval (EMA) on schedule April 2011

    7) FDA turn around time 2-6 months (estimated until meeting with them)

    8) PLX management team confident of approval in 2011.

    GLTA

    Investor 100

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • did mgmt outright say EU approval timing of April??

      based on Vpriv timelines, my calculation tell me sometime in late august/early september

      Sep 10: Launched in the UK [21].
      27/09/2010 11:38:22
      Aug 10: Approved in EU [20].
      27/08/2010 09:43:02
      Jun 10: EU positive opinion recommending velaglucerase alfa for long-term enzyme replacement therapy in pts with type 1 Gaucher disease. Home admin under the supervision of a healthcare professional may be considered for pts who have received & tolerated at least 3 infusions [18].
      28/06/2010 10:23:04
      Mar 10: Approved in US to treat children and adults with Type 1 Gaucher disease [16] .
      01/03/2010 17:44:17
      Feb 10: Shire plans to market velaglucerase alfa under the name VPRIV and it will charge 15% less than Genzyme´s price for Cerezyme [15].
      19/02/2010 20:07:08
      CHMP has accepted the manufacturer´s request for an accelerated review of the application because of the global supply shortage of imiglucerase (the currently licensed treatment for Gaucher disease) and positive results from three PIII velaglucerase trials (13).
      27/11/2009 15:49:32
      Nov 09: Filed in EU for type 1 Gaucher´s disease (12)

      • 1 Reply to flintsta79
      • PLX won't be hearing back on any possible European approval until June at the earliest. They only submitted their MAA in Nov 2010:

        From 2010 10K:
        "In December 2009 we completed the filing of an NDA for taliglucerase alfa for the treatment of Gaucher disease and received a PDUFA date of February 25, 2011, and in November 2010, we submitted a marketing application to the Israeli MOH and an MAA to each of the EMEA and ANVISA for taliglucerase alfa. "

        It takes 210 days to hear back on these filings, which puts the date in June 2011. EMA and FDA coordinate pretty closely these days, and the FDA rejection PLX got will set the bar that much higher for first cycle EMA approval.

    • Stock should move higher as it approaches Europeon approval date in april and as the FDA meeting approaches in the coming months imo. Glta.

    • Thanks for the summary. EMEA approval would be good to see.

 
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