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VIVUS Inc. Message Board

  • trinikajo trinikajo Jun 24, 2012 5:56 PM Flag

    atlnsider Most of the panelists said monitoring could be done POST-APPROVAL...

    Report this Comment On June 24, 2012, at 12:37 AM, voxlisa999 wrote:

    Read the just released 5/12/12 AdCom transcript NOT the Meeting Minutes, they are not accurate. The vote and each panelist's comments starts on page 348.

    Dr. Peter Gross- former FDA Chairman Drug Safety and Risk Management said, in discussing his vote:

    "On balance I thought the benefits clearly outweighed the risks. It's time to approve this drug. We did nor put our head in the sand. I think that the signals are not strong enough to require a risk management program." pg.382

    ALL of the panelists said monitoring could be done POST-APPROVAL.

    http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMe...

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • Trinikajo;

      I, along with most everyone else, believe that Lorcaserin CVOT can and will be done post-approval. That is not the question.

      The question is: When will Lorcaserin be approved?

      I do believe that it will be approved eventually, but not on June 27th. I believe that Arena will have to submit the designs of a post-approval CVOT study to the FDA first. The FDA will review the CVOT study designs, and then recommend changes, and/or approve the CVOT study designs. Once the FDA approves the CVOT study design, then Lorcaserin can be approved. Take a look at item No.5 on page 3 of this FDA document:


      http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/StaffPoliciesandProcedures/ucm082002.pdf


      As I told Soulseeker and Alibi, I have posted some excerpts from the FDA Lorcaserin Adcom transcript to support my conclusions and opinions, you are welcome to post some excerpts that support your opinions.

      • 1 Reply to atlnsider
      • altel if you read the transcript as I posted, wost of the ADCOM panel that voted yes said that "Most of the panelists said monitoring could be done POST-APPROVAL" Please read through it.

        I am not a physician so I am not qualified to defer from the facts given by these doctors.I do the anaylsis of what I read and heard......and from there I base my decision.
        To answer your question, yes it will be approved with not delay (which we should have seen by now).

        You truly don't believe that if the CVOT changes were needed we would have not seen them by now?

    • If your going to post, then post the postive with the negative as I did when I was the first to post the ADCOM link on this board.

 
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