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Pozen, Inc. Message Board

  • matrixmania55 matrixmania55 Jul 16, 2014 9:41 AM Flag

    Co. should have said more in release

    very foolish not to have. Shareholders have a right to know what the heck the problem is with the Supplier, Period!

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    • This is from an FDA document, admittedly dated April 1998, called "Guidelines for Industry: Classifying Resubmissions in Response to Action Letters". Note the last sentence.

      A Class 1 resubmission is a resubmission that includes the following items only (or
      combination of these items):
      1. Final printed labeling
      2. Draft labeling
      3. Safety updates submitted in the same format, including tabulations, as the original
      safety submissions with new data and changes highlighted (except when large
      amounts of new information, including important new adverse experiences not
      previously reported with the product, are presented in the resubmission it will be a
      Class 2 resubmission).
      4. Stability updates to support provisional or final dating periods.
      5. Commitments to perform phase 4 studies, including proposals for such studies.
      6. Assay validation data.
      7. Final release testing on the last 1-2 lots used to support approval.
      8. A minor re-analysis of data previously submitted to the application (determined by
      the Agency as fitting the Class 1 category).
      9. Other minor clarifying information (determined by the Agency as fitting the Class 1
      10. Other specific items may be added later as the Agency gains experience with the
      scheme. These will be communicated through guidance for industry.
      A Class 2 resubmission is a resubmission that includes any other items, including any item
      that would warrant presentation to an advisory committee. Any submission that would
      warrant a re-inspection is considered to fall into the category of a Class 2 resubmission.

      • 1 Reply to mini_maxx
      • As I read the regulation, and assuming it's still in effect, any resubmission requiring more than a review of paperwork, and certainly any review requiring a re-inspection, falls into the class 2 category. In its PR a couple of weeks ago POZN said it had audited the supplier facility but it didn't say the FDA had. Since it's a foreign facility it's possible the FDA just hasn't had time to re-inspect yet. POZN's July 1 PR also said the supplier had submitted a supplement to its May 9 initial response to the FDA, which may also have contributed to the delay. It would obviously be helpful if POZN explained the nature of the problem. But while there's no guarantee it will be fixed to the FDA's satisfaction upon re-inspection, I'm not aware of any instance where the FDA required clinical trials to be repeated due to a mfg problem. Not saying it's never happened but my gut -- which does occasionally make mistakes -- says it's unlikely.

    • Probably the problem is not fixed yet, that's the reason new date is in 6 months. The good part of it is there is new date, so we know what are waiting for.

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