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FRX Message Board

  • forstrngr forstrngr Jun 8, 1998 9:22 AM Flag

    Any day now

    The Celexa approval is imminent. An FDA approvable letter means that only minor issues, such as labeling, need to be resolved.

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    • FDA may ask you to do another trial in the
      approvable letter (long-term studies, or interaction
      studies, etc). For example, CEPH's approvable letter means
      non-approval because FDA wants new data.

      We have to
      make sure that FDA only request some minor issues from
      FRX. Did anyone read the approval letter?

      this the reasom why the stock price went up to $39 and
      goes down to $33 today after the 5/13 news?

      • 2 Replies to lipolong
      • It is my understanding that there are only
        labeling issues being thrashed about, although I haven't
        seen the approvable letter personally. It is not yet
        available on the FDA-CDER website (
        The impression I have is that the approval will come
        this summer. When it does, Celexa has the potential to
        knock Prozac down for the count. It does not have the
        sexual dysfunction side effects that Prozac does. Forest
        has an excellent sales force, and they will be
        co-marketing with Warner-Lambert.
        The stock price is still
        relatively low, around $33. It might be a good time to add
        some shares to your portfolio.

      • It is my impression that the Forest Labs
        anti-depressant medication is on track and set for final
        approval. I personally do not read too much into the
        approvable vs final approval possible percevied issue in
        this case. This anti-depressant has been on the market
        in other parts of the world for some time and in
        fact, I beleive, in certain European markets is the
        number one drug in its class. It has in fact according
        to all reports that I am aware of been associated
        with perhaps even less side effects and drug
        interactions than other similar medications and may be better
        tolerated in the elderly. Of, course, there is always that
        small (but ever present) risk that something will go
        amiss in the approval process atr this final juncture.
        Then again, it wouldn't really be investing would it
        if everything was a sure thing?

        It would
        appear that this could be a very significant product for
        Forest labs if all goes as anticipated. The market is
        hugh and lead products in this feild can eventually be
        $1 billion plus (in sales) drugs. This would, if
        successfully approved, launched and accepted by the medical
        communuty (as it has been in Europe) be Forest's first real
        blockbuster. Coupled with continued sales trends of its
        present major product base this could translate into very
        significant increases in earnings beginning perhaps 6-18
        months post-launch with stock price appreciation
        following earnings.

        Forest seems to me to be a nice
        intelligent speculation for significant 3-5 year appreciation
        (sooner if approval is forthcoming and launch and
        promotion is accelerated and successful). Of, course, there
        are no guarentees but this does look like a very
        sound reasonable bet to me at least.

        Please let
        me know what you all think or any other

        Good luck!