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Titan Pharmaceuticals Inc. Message Board

  • matthewbergey1770@gmail.com matthewbergey1770 Sep 4, 2013 8:45 AM Flag

    Appeal

    Is Titan/Braeburn appealing to higher ups here?,guess I am at a loss what is actually happening...

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    • I think a Type A meeting would have been requested if they were appealing.

      A Type A meeting is a meeting needed to help an otherwise stalled product development
      program proceed. Examples of a Type A meeting include:
      • Dispute resolution meetings as described in 21 CFR 10.75, 312.48, and 314.103 and in
      the guidance for industry Formal Dispute Resolution: Appeals Above the Division Level
      • Meetings to discuss clinical holds in which a response to hold issues has been submitted,
      but the FDA and the sponsor or applicant agree that the development is stalled and a new
      path forward should be discussed
      • Special protocol assessment meetings that are requested by sponsors or applicants after
      receipt of FDA evaluation of protocols under the special protocol assessment procedures
      as described in the guidance for industry Special Protocol Assessment

      Source: Guidance for Industry Formal Meetings Between the FDA and Sponsors or Applicants

      • 1 Reply to exdaytrader777
      • Type B meetings are as follows:4

        Pre-investigational new drug application (pre-IND) meetings (21 CFR 312.82)

        Certain end-of-phase 1 meetings (21 CFR 312.82)

        End-of-phase 2 and pre-phase 3 meetings (21 CFR 312.47)

        Pre-new drug application/biologics license application meetings (21 CFR 312.47)
        Type B meetings should be scheduled to occur within 60 days of FDA receipt of the written meeting request. If a sponsor or applicant requests a meeting date that is beyond 60 days from the date of request receipt, we will work with the sponsor or applicant to determine the earliest agreeable date.
        To promote efficient management of formal meetings, the requestor should try to anticipate future needs and, to the extent practical, combine product development issues into the fewest possible meetings. Generally, we will not grant more than one of each of the Type B meetings for each potential application (e.g., investigational new drug application (IND), new drug application (NDA), biologics license application (BLA)) or combination of closely related products developed by the same sponsor or applicant (e.g., same active ingredient but different dosage forms being developed concurrently), but we can do so when it would be beneficial to hold separate meetings to discuss unrelated issues. It also may be appropriate to conduct more than one of some of

 
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