Impax Laboratories (IPXL) gets hammered after FDA inspectors say they've found continuing...


Impax Laboratories (IPXL) gets hammered after FDA inspectors say they've found continuing problems at the company's Hayward, California manufacturing facility that may affect new and pending drug applications. Issues the agency found include problems related to the testing and evaluation processes for its Parkinson's drug candidate Rytary, as well as other products. Inspectors also said the company failed to identify the cause of broken tablets of its anti-inflammatory drug Carprofen. Shares -18.8% AH.

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Comments (2)
  • Scrying Biotech
    , contributor
    Comments (2721) | Send Message
     
    This is a failure in leadership. At one time, in the not too distant past this company was poised to make a run at $30 a share. A Rytary approval and expected revenues would have driven Impax toward $1Bn in annual revenues in only three years time.

     

    How things have changed in only six months time! Dr. Larry Hsu said on several occasions that the original warning letter on Hayward involved only "procedural" issues and that they had been ready for some time for re-inspection. Apparently not!

     

    It seems to me Dr. Hsu, that you are to blame. With so much on the line for Impax Labs and its shareholders, every precaution should have been taken to make sure that this facility was spot on clean and ready to go. You had over a year to prepare and the FDA found "broken tablets" with no explanation on your part as to the cause of this anomaly? For shame!

     

    Impax Labs should have spent $100mm of its $300mm cash on hand prepping those facilities for re-inspection. That would have been a good investment of company capital in lieu of a half billion dollars in expected annual revenue that has now been lost.

     

    Bad on ya!

     

    Michael Webb
    5 Mar 2013, 03:19 AM Reply Like
  • TheMandrake
    , contributor
    Comments (42) | Send Message
     
    The FDA should shut down operations, period.
    5 Mar 2013, 05:41 AM Reply Like
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