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  • gusvondel gusvondel Jan 8, 2010 12:16 PM Flag

    Shall ACTC let investor know FDA questions?

    Shall ACTC let investor know FDA questions? what's the legal time line in this?

    Guess no one knows.

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    • Now, here is the response Dan submitted when I asked what the grounds for the hold were:

      "When the FDA's response is received, we'll be able to answer your question. Until then, we will await the FDA letter.



      Thats what Dan told me when I asked why there wa a hold. Supposedly, ACT does not know if there even is a hold yet for all they know the letter can be acceptance. All they know is a draft is in process. Hope that helped.

      • 2 Replies to theshark718
      • They know that they are on clinical hold - PERIOD. The PR states it!

        Quote from ACTC PR:

        "ACT is currently on clinical hold pending a response from the Agency, which it expects within the next few weeks."

        If you read up on the process at the FDA's website you will see that the FDA has 30 days to inform ACT as to why they are on hold.

        "(d) Imposition of clinical hold. The
        clinical hold order may be made by
        telephone or other means of rapid communication
        or in writing. The clinical
        hold order will identify the studies
        under the IND to which the hold applies,
        and will briefly explain the basis
        for the action. The clinical hold order
        will be made by or on behalf of the Division
        Director with responsibility for
        review of the IND. As soon as possible,
        and no more than 30 days after imposition
        of the clinical hold, the Division
        Director will provide the sponsor a
        written explanation of the basis for the

      • If ACT would not proceed by their own decision, they would know why they are not proceeding. Everything indicates that the FDA issued a hold and the company will get the reason in a few weeks. Most likely in the next 30 days.