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Bioniche Life Sciences Inc. Message Board

  • brl5324 brl5324 Mar 5, 2010 6:42 PM Flag

    When are phase III results due?

    Thanks.

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    • The quick answer – May/June 2010.

      The more detailed answer is I’m aware of 3 ways to estimate the results date here :

      * On 31 March, 2009 Bioniche issued a press release saying they had completed recruitment in the trial. The primary end-point is measured 12 months after treatment. Therefore, the final recruited patient will have reached their primary end-point measurement at end March 2010 (assuming they didn’t drop out earlier). At that stage, with all primary end-points measurements made, the analysis phase for the trial’s primary end-point begins. This varies from trial to trial but should be in the 4-10 week range. This gives end April 2010 to June 2010 as the answer.

      * The FDA requires details of all human drug trials to be logged on clinicaltrials.gov. Linked to this, the FDA requires the ‘Estimated Primary Completion Date’ for the trial to be shown. This currently shows April 2010. The analysis phase of the trial would take place after this (discussed above) and so gives May/June 2010 as the answer. Finally, the April 2010 entry was updated on 13 May 2009 which is after the final patient had been recruited and so should be accurate – some trials leave out-of-date estimates on their clinicaltrials.gov entries for long periods of time.

      * Bioniche’s 5 November 2009 presentation to shareholders states “results to be available mid-2010”. I would interpret this to mean June/July 2010.

      These 3 different methods produce a range from end April 2010 to July 2010. However, the strongest area of overlap occurs in May/June 2010 and that, as a result, is my estimate.

      I hope this is of help to you.

    • Sometime in 2010, but not in the near future. If every dime you have is riding on this one, then patience will be a virtue.

 
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