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  • nohype88 nohype88 Nov 15, 2005 5:34 PM Flag


    There are a lot of questions that need answers. My confidence in SUPG is rapidly diminishing, particularly after today�s events. Here is why:

    The FDA �approvable letter� for the Dacogen injection was received on September 1, 2005. The letter provided that the Dacogen injection is approvable pending the FDA's review of a requested analysis of the transfusion requirements of patients enrolled in the completed phase 3 trial, submission of certain other information, and completion of labeling discussions.

    My first question is why did SUPG not anticipate any of these items, thus avoiding delay in approval? Second, why did it take ten weeks to respond? Third, based on the September 1, 2005 receipt of an approvable letter - instead of an approval - did SUPG take any immediate steps to determine the impact the situation with the FDA would have with European regulators? Fourth, precisely when did the European regulators indicate to SUPG that they would require additional clinical data on the use of Dacogen injections? Fifth, when and what steps did SUPG take to determine the nature of the additional information sought by the European regulators? Sixth, am I the only one that finds it suspicious that these two announcements came out on the same day (e.g. SUPG announced its submission of their response to the FDA�s approvable letter and revised European strategy? Seventh, the announcement with respect to the European regulators indicated, �the companies said they plan to resubmit the application at a later date, possibly with another partner.� Who is the �another partner� and what are the details?

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