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Impax Laboratories Inc. Message Board

  • kevsmi2424 kevsmi2424 Jan 21, 2013 3:29 PM Flag

    Hayward Plant

    If issues with this facility with the FDA go back to May 2011,(20 months) couldn't they basically have blown it up and totally rebuilt it in less time...

    Sentiment: Buy

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    • penny pinching nitwits. i fendin to head on over and eat a bucket a MR. chicken because i feel discriminated against. My chinese broker said this the taiwan rocket . More like a taiwan tird if you ask me

    • It's not a physical issue, it's their documentation practices and protocols that were not up to spec for the FDA.

      • 2 Replies to tanis2476
      • I don't mean to be the bearer of bad news, but I think that people here are failing to realize the seriousness of the Hayward/FDA warning letter situation. This is not just a simple matter of paperwork issues, and this is not a situation where approval could be given to Rytary with a quick fix. This is a big deal, and resolution is likely at least a year away, requiring the Hayward production issues to be resolved to FDA satisfaction, followed by a new/updated FDA application for Rytary, along with another 6 month waiting period for a decision.

        May 2011 is not even where the story really begins with the Hayward facility issues. They actually go back quite a ways further, as that FDA warning letter was based on a reinspection of the facility regarding problems that had come up back in April of 2010, and even before that time, that were not corrected satisfactorily according to the FDA.

        Any investor in this company should spend a few moments to carefully read the actual details of the FDA warning letter, which can be found at (link removed - do a search for fda impax warning letter, and it should be the first result). It is not a very difficult read, and it is important to read this for yourself and not just listen to what message board posters may be saying about it. One must think very carefully about the following observation as noted within that warning letter, which is based on the inspection that took place from December 13, 2010 through January 21, 2011, "For example, our investigators identified up to 75% of the manufactured lots of various drug products having one or more metal-contaminated tablets." 75%....That is not a small figure. It goes on to say the following, "The corrective actions implemented after the April 2010 inspection, as result of the metal contamination, are ineffective as evidenced by the continuing issues observed during the most recent inspection." Meaning that the company was previously told about the issue, had 8 months to fix it, and completely failed to do so. With another year gone by since that time, how in the world can management explain not having this resolved already, especially considering the number of drug applications on the line because of it, and particularly with some of them being fairly significant to future growth? Management knew full well that this issue could/would delay approval of any pending FDA applications that have anything to do with the Hayward facility, and the CEO even said such quite clearly in the October 30th earnings call (script available at Seeking Alpha).

        Another interesting tidbit is a report from 8/2010 regarding the cleaning and investigation issues as originally documented at the Hayward facility, including metal contamination, located at (link removed - search for impax fda warning april 2010, then find the link titled INSIDE THIS ISSUE - FDA News, and search that PDF for Impax), and finally, although quite difficult to comprehend, you can view the FDA 483 form that was filed regarding the original Hayward facility observations, which is linked a the bottom of that PDF article.

        I know that message boards are typically made up of investors that are long in the particular issue, and that messages like these are frequently met with objections, or accusations of the poster just being a short trying to spread fear. I promise you that I have no position here, I only spent my brief time here out of my own curiosity about a PDUFA-related issue, and I am only intending to share the information that I believe any shareholder here should keep in mind when deciding what to do going forward. In fact, I personally have a family member with Parkinson's, so I know first hand and all to well how serious it is, and I would love nothing more than to see a drug get approved that could actually help. However, that desire will not blind me to the facts and details pertaining to this specific situation. I think it is important for every investor not to have blind faith in a company, or to love a stock, or to listen much to other message board posters without doing their own research and/or follow-up, and actually reading and understanding what is happening to the best of their abilities before making any investing decisions.

      • OK...shouldn't that take even LESS time!

        Sentiment: Buy

 
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