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Discovery Laboratories Inc. Message Board

  • icdcweb icdcweb Jun 4, 2009 5:27 PM Flag

    This say FDA Meeting schedualed fot 6/2/09

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    • irenecarol@bellsouth.net irenecarol Jun 4, 2009 10:28 PM Flag

      It says following the meeting we will hear from dcso. Has anyone heard anything from tuesdays meeting?????????????
      Discovery Labs (NASDAQ:DSCO): On 5/11/09, DSCO announced that it has received written notice from the FDA that an end-of-review meeting has been scheduled for 6/2/09 to determine the resolution of the remaining primary issue necessary for the Company to gain U.S. marketing approval of Surfaxin (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. Following the meeting and receipt of formal written minutes from the FDA, DSCO plans to provide an update, including the expected timeline for the potential approval of Surfaxin.

      • 2 Replies to irenecarol
      • Irene, for a nurse, you should be sure to read what is on the label of the drugs you administer.

        Likewise, be sure to read what Capetola said: Following the meeting AND receipt of formal written minutes from the FDA....

        Since you are not a fortune cookie reader, please wait 30 days like the rest of us, for the FORMAL WRITTEN MINUTES

      • No, and you aren't going to hear anything until the end of June or very early in July.

        The FDA procedures are to issue the formal minutes of the meeting within 30 days after the meeting. Many steps have to be taken before the final minutes of the meeting are released. Each FDA group that was at the meeting has an opportunity to review, and correct or revise the minutes of the meeting. Then, at about 15 days after the meeting, the company has an opportunity to provide input, probably at a meeting, regarding the minutes of the meeting. Finally, after everybody has had a chance to have more meetings about what was actually discussed, said, and decided at the meeting, the meeting coordinator will issue the final minutes of the meeting- at about 30 days after the meeting.

        Everybody that is, except you.
        You don't get to see the minutes of the meeting.
        Those minutes of the meeting are reserved for the personal and private use of the people that were actually at the meeting, and said and decided those things at the meeting, to remind them in the future of what was said and decided at the meeting.

        So you will have to wait for DSCO to tell you what they want you to know about the meeting. They will not tell you everything that was said and decided at the meeting. They will dress up that pig to look like a million dollars and tell you how absolutely fantastic the meeting was, and how much fun it was, and don't you wish you had been there. Party party party. Meetings are so much fun.

        Why don't you call up Lisa and see if you can schedule a meeting to discuss the minutes of the meeting. I am just sure she will set aside some time for you. She can call a meeting to discuss the office calendar and see when they could schedule your meeting.

        Can you bring the donuts?

    • and?




      oh, you mean what was the result of the meeting?




      stay tuned mr. dumass

 
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