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Impax Laboratories Inc. Message Board

  • mundeleinmike2 mundeleinmike2 Jan 21, 2013 1:38 PM Flag

    What you should know about FDA timeframes & Rytary...

    I have no position long or short in this company, and I was only following it because I have an interest in PDUFA-related stock investments, but I thought I would share the following information before moving on.

    Investors here should understand that this is not a quick-fix. Approval will require a meeting with the FDA, which could take 2-3 months, followed by a successful reinspection of the Hayward facility and closing of the original FDA warning letter (along with resolving anything else that may arise from the FDA meeting), which could take an undetermined amount of time, and finally an updated submission for FDA approval would need to be filed. The company would be informed within 14 days of filing whether or not the FDA has accepted the NDA resubmission as complete, and it will be assigned a Class I or Class II review. Reviewing current FDA procedures, a resubmission that requires a reinspection would be a Class II review, which is a 6 month review from the date of submission.

    With all of that in mind, the resubmission and possible approval process will likely take a minimum of 11 months, and possibly much longer depending on the timing and results of the Hayward reinspection, especially considering that IPXL is batting 0-2 over the last 2 years in that situation. So, long story short, this is going to take some time. On the plus side, although it may not feel this way to the retail investors/speculators holding February options at this time, because the stock did not take a large run up leading into this decision, and is not widely followed or heavily traded, the aftermath may not be quite as devistating as is typically the case in these situations.

    The bigger picture problem here may be that any and all other pending applications that IPXL has out there at this time will likely face the same situation, and nothing positive is likely to happen until that 2011 FDA warning letter regarding the Hayward facility is closed. The last thing that I will mention of additional concern is that, as described in the press-release, "During the assessment of the NDA, the company withdrew the Hayward site as an alternative site of commercial production at launch." To me, this implies that if the easy way out for IPXL was to attempt to switch production facilities, then management is likely well aware of the problems that exist with the Hayward facility, the potential time and cost to remedy those issues, and finally that the situation may not be as simple or quick to resolve as investors might be hoping for.

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    • Do you have any idea why the FDA would hold up approval if Hayward was withdrawn as an alternative production site? Is the FDA holding Rytary as a "hostage" to get Impax to move on Hayward? Or was Impax's "withdrawal" inconsistent with FDA procedures? This is a real puzzle to me - can you shed any light?

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