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  • Buying Opportunity In Durata Therapeutics [View article]
    Since you mentioned FDA rejection, let's take a look at the "approvable" letter (now CRL).

    "The FDA recently published a draft guidance on studies designed to show non-inferiority as a basis for approval of antibacterial drug products and has requested that Pfizer provide additional data with regard to dalbavancin. Pfizer is working with the FDA to respond to these new requirements.

    Separately, the FDA approvable letter refers to deviations from current good manufacturing practices (cGMP) at a third-party manufacturer, not specifically related to dalbavancin. The third-party manufacturer is working with the FDA to resolve outstanding manufacturing issues.
    "

    The main reason FDA declined it is because FDA changed its guidance on non-inferiority trial, which was not in place when the previous Dal trials were designed!

    Also some manufacturing issues not specifically related to dalbavancin.

    Durata conducted two new phase 3 trials with SPA under new FDA guidance. Both trials met end points with flying color. Dalbavancin will have a very good chance to pass FDA this time.
    Jul 11 08:43 AM | 4 Likes Like |Link to Comment
  • Buying Opportunity In Durata Therapeutics [View article]
    Thanks! check out my recent blog that provides counter-arguments to some common mis-perceptions of Dal.

    http://bit.ly/12V0khe
    Jul 9 08:55 AM | Likes Like |Link to Comment
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