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POZEN Inc. Message Board

  • valuebuy2005 valuebuy2005 Jun 5, 2014 10:23 AM Flag

    POZN CRL respone imminent

    FLML got API supplier issue fixed today and will refile this month. FLML has about the same PDUFA date and same CRL content as POZN. Looks like Jason's estimation from Zack is right on.

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    • They received their answer to their file in April so it's likely they will receive an answer in 60 to 90 days or at the outside Sometime in July. Their next review and quarterly report may show up within a week or two of each other. That might make for a nice advance in the price should the news be positive AND there is no reason to believe it would be otherwise.

      The company has an improving bottom line and pending the resolution of the current situation, things can only go up.

    • It means nothing. The FDA will do things according to a schedule only they understand.

    • investor71@att.net investor71 Jun 13, 2014 11:08 PM Flag

      Won't happen until at least October, you guys just don't get it.

    • It's certainly possible. Another reason may be institutions may have done a bit more Due Diligence and discovered there is nothing to be concerned about concerning the drug itself.

      What has bothered me is the "simple" problem with a supplier seems to be rather difficult for the company (POZN) to get resolution too. I've contacted them several times on the phone and in writing. They flat will not make any comments regarding this very important situation.

      I will remind readers that the President & CEO said they would try to have answers in their teleconference. In the teleconference the company started their initial comments with the statement that they would not be addressing these issues during the conference.

      For me this smacks of a lawsuit or potential lawsuit in play. I personally wonder if this issue resulted as a matter due to the direct failure of the FDA site inspector to get the letter with the issues to POZEN in a timely manner. Again I 'll ask you to remember the inspections was done days prior to the approval date. It is customary that these reports are forwarded immediately so that companies can address the issues to seek a correction of the problems ahead of the decision and announcement. In the public record we have been told the FDA delivered the Inspection report the day of the announcement. One has to remember, POZEN was in a PDUFA review. This means the CRL would have delayed marketing their drug while competitors gain a greater foothold in the market. An approved PDUFA equals the ability to sell the drug and earn profits. Now lost profits.

      Lost profits due to an FDA failure equals lost market share which translates by law into a material injury.

      These are thoughts I've had. Maybe you also considered this possibility.

      What do you think??

      • 1 Reply to wm.craigbarnard
      • If you're suggesting POZN may try to sue the FDA because of the #$%$ they pulled, forget about it - they are immune from lawsuits except for extremely limited cases, none of which apply to us or POZN. They won't talk to you because the info is material news, they'd be breaking SEC laws if they said a single word before the facility passes reinspection.

    • Dumb statement, No one knows what the issue is with their supplier vs. the other. Until its made public you are just guessing. One has nothing to do with the other.

 
POZN
8.17+0.27(+3.42%)Dec 19 4:00 PMEST

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