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Boston Scientific Corporation Message Board

  • biokaze biokaze Dec 21, 1998 11:44 AM Flag

    Single digits????

    The stock is rebounding nicely today. Let's see what they have to say at 5.

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    • History also tells us that FDA likes to make
      examples out of certain companies to send a signal to the
      industry. Previous actions against Physio-control for GMP
      violations several years ago shut them down for an extended
      period. This sent a ripple through the medical device
      sector and got a lot of attention in terms of fostering
      compliance with GMPs. This case with BSX may be another
      example the FDA is trying to set for the industry that is
      running fast and hard to get new products to market. FDA
      is under pressure to adopt the new provisions in
      FDAMA while at the same time buried under a mountain of
      submissions for new products. This may be one way to signal
      the companies to slow down. The problem of volume of
      submissions at FDA will not go away and in fact may be
      worsened by such a move as companies may become more
      conservative and submit changes that would have not normally
      been sent in. I am not bashing BSX just offering a
      historical reference. It is unfortunate that the Sox recall,
      japan reporting, and now DOJ issue coninsided. They say
      things happen in 3's so hopefully for the investors this
      will be it and it will be over soon. I will spare you
      my Clinton analogy on the outcome here, just use
      your imagination and hope for censure.

    • What would a contrarian do with BSX stock at this time?

    • Sell it if you got it....hopefully the criminals are going down...hasta la vista!

    • That is to say FDA has investigators of its own
      to evaluate regulatory compliance or lack thereof.
      DOJ, with the participation of the FBI, is looking at
      BSX for potential violations of civil and/or criminal
      law. It very well could be that DOJ/FBI involvement
      will result in no further action. However, the last
      major company I remember being in this position was
      Columbia/HCA. Company statements similar to those being made by
      BSX ("We don't know what's going on," "Fully
      cooperating") were made shortly after the investigation was
      announced. Subsequently, I believe both civil and criminal
      indictments related to activities of COL middle managers in
      several states were filed with the cases still going on
      (I believe).

      These guys (DOJ) don't lauch
      investigations unless they have a good idea they're gonna find
      something. They're bureaucrats! Whether that something is
      major or minor, criminal or civil or both is what is to
      be determined.

      It is beyond me how anyone
      could presently have confidence in this stock given the
      company's statements that they have no idea what DOJ is
      concerned about beyond events surrounding the NIR recall.
      My guess is, as previous poster suggested, there are
      suspicions of falsification and withholding of preapproval
      clinical data. While no attorney, I would think that if
      ommitted or committed falsification is discovered it would
      constitute fraud. Knowing the feds they're likely to spruce
      up the charges to involve RICO statutes and hang a
      lot of people out to dry. Of course a group that
      stands to lose a lot would be immune from prosecution
      but would be no less punished: individual
      investors.

      The street has been forgiving of this stock to a
      fault. Perhaps all of this investigative activity will
      come to naught. However, if there are problems, esp.
      if criminal indictments are filed, THEN will be the
      time to buy BSX.

      More later.

    • Any speculation on how long it will be before
      something either comes out of the investigation or it
      disappears? Will there need to be some sort of closure before
      the stent can be reintroduced? From what I
      understand, they can let an investigation linger and never
      actually disclose that it is a closed investigation?

    • Where were you when JNJ's share fell from 95% to
      11%? As an industry-watcher, I've been quite
      underwhelmed with JNJ's attempts to regain this share with
      their latest "next-generation" offerings...it's
      apparent that JNJ management isn't overly concerned with
      success in the IC marketplace...considering the recent
      run-up in JNJ share price, there doesn't appear to be
      much incentive for Larsen and co. to be concerned...

    • For those of you who have asked my opinion
      regarding other companies I think that the good and kind
      Mr. Detective can give you better answers. I look at
      management, EVA/MVA, strategy, etc. S_D is better at the TA
      stuff for shorter term investing. There are lots of
      things about the Internet such as band width and
      availability (QWST) and Java (SUNW) and stuff like that. The
      biggest thing is that CSCO is larger (sales) than all of
      their competitors combined. I forgot to add BSX to that
      list, things are rocky now but they still make lots of
      money, have good overall management, and the EVA is
      very, very good.

    • Another theory, pure and simple, is that DOJ is
      an investigative agency, and FDA is not. If FDA has
      suspicions re who knew what when, etc., DOJ is in a much
      better position to get to the bottom of it -- they have
      the staff and resources. They are also trained attack
      dogs, so it's definitely not a positive development.

    • Since you ask for theories, keep in mind this is
      pure speculation:
      If the FDA believes BSX knew
      they were not properly reporting problems, and if FDA
      believes BSX acted as they did because BSX knew they could
      make the proper changes and submit and leaves FDA with
      little to do but authorize the change and therefore BSX
      comes out clean, FDA may have called in DOJ to let BSX
      know they have some options besides giving BSX an OK
      after the late submission.

      Happy Holidays.

    • I think the FDA/DOJ is after two
      things:

      1. Evidence that premature balloon failure occurred
      in the clinical trials which was not reported in the
      results.

      2. Change in design that was not reported in the
      submission.

      What is worrisome is that the FDA can just ask for the
      info. Since they are using the DOJ to get it for them
      to me means that they don't trust that everything is
      being turned over.

      Anyone else have any
      theories?

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