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Impax Laboratories Inc. Message Board

  • mundeleinmike2 mundeleinmike2 Jan 19, 2013 7:56 PM Flag

    Question of FDA warning letter

    After reading up a little bit about the historical problems with the Hayward facility, I am a little confused, because it seems to me from what I read that perhaps new drug applications that will be made at that facility cannot be approved until the issues are resolved and the FDA warning letter has been closed. Is that not accurate? And, as far as I can see, that has not yet been completed at this time. So, I am thinking that there is another delay coming here for Rytary. Also, Friday's activity specifically, along with recent price action, don't exactly show the trendlines of a company that is or even might be about to get approval for a potentially fairly significant drug. I don't own any of this stock, but I do like playing PDUFA-related issues in general. However, I am always wary when there are historical FDA issues involved, and 2 years in a row of having unresolved production plant problems with the FDA at the same facility, well that is not a good thing. The fact that new issues were discovered at the 2011 FDA reinspection does not say much for management in my opinion. Anyways, best of luck to all of you, and this may get this approval at some point, but personally, I don't think it's happening this time around. As I posted in another topic, I believe that the company has 48 hours to make whatever information they are given by the FDA public, but if notification had already been received and was not good, I would have thought that they would have tried to bury it late Friday night before the long weekend, so I guess you never know...

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    • Wow, that was extremely insightful. Thanks
      5 stars for Mike *****

    • Your conclusions are without merit. The Hayward facility is not their only manufacturing facility so it is unclear why you believe its issues would defeat approval. For all you know the issues may have been resolved and will be disclosed upon receipt of FDA's decision regarding the drug. Significantly, the three month delay had nothing to do with the Hayward facility so it is unlikely they would now issue a delay based on it. Morevoer, it they were going to issue a delay based on the Hayward issues it is unlikely the FDA would wait for the PDUFA date to issue the delay. As for Friday's stock movement you should note the volume was barely above average. It is not unusual for a stock's price to drop or jump shortly before a binary event such as an FDA decision. The stock was up 3% on Thursday. Interestingly, Friday's call volume was 4 times that of put volume. Lastly. the drug met its endpoints and adverse side effects were minimal which should lead to approval this week.

    • I think your analysis is good, and agree another delay is possible. However, the company has massive amounts of cash and is rumored to hired production managers from another pharma company. Given the backlog of products it is likely the FDA letter should be resolved quickly, after all there are few business problems that money can't solve.

      Sentiment: Buy

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