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MannKind Corp. Message Board

  • kkobe36 kkobe36 Dec 18, 2013 11:34 AM Flag

    Old timers,

    I do not remember us even discussing the 74 day letter before the last 2 submissions. How comes it was non event then? Are we only excited this time round because Matt brought it up as something a potential partner is interested in seeing first? My feeling is that it will come and go with little more than a ripple, and we are making way to much out of it. Thoughts?

    Sentiment: Strong Buy

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    • I believe this is part of procedural changes made in about 2011 . They were supposed to make the FDA more responsive. Seems unlikely.

    • You're right. I've been on this board for over nine years and, until recently, I had never heard of the 74 day letter. I doubt it's very important now!

      Sentiment: Strong Buy

    • At least in the old days, we would go up if the Dow went up 300 points.

    • pfg_01 discussed it back in 2010, when he compared MNKD'sFDA process to Biodel's. Would you like me to bump it?

    • Too good of a string of posts to be buried so soon...

    • The negotiations at Greenfield certainly can't be basic partnership as the details would be fundamental and the blue print simple to follow and completed by now. Given the amt. of time dedicated to their mission, there must be highly complicated agreements/fomulas/milestones that come into play that demand a high level of mutual and assignable commitment. I speculate that the partner (or buyer) wants a clean 74 day letter before officiating the contract. If the 74 day notice comes at the end of the month (as scheduled) something should be announced by MNKD concerning partnership status immediately thereafter or early Jan. If not, my level of concern will be cranked up. Most of us thought that Dec. would be a MNKN month to remember but it's beginning to look like a wash at this juncture.

    • I still want to know who offered up the Johnny Walker Blue, and for what? I also believe there was going to be a Vegas party. How time flies when you are having fun and looking through our rose colored glasses, lol.

    • I'm with you on this one. There never was any "bad" 74 day letter that we heard of, and never an advisory committee, and we still had 2 CRL's. It may help somehow with partnering behind the scenes, but I believe there will be milestone money on actual approval and not just a clean letter. I certainly think a clean letter will keep us from having one more hurdle, but I don't think anyone expects a problem anyway, and so I don't see any change in the share price either.

      Sentiment: Strong Buy

    • I think it is different this time because potential partners want all the hurdles and issues removed, however minor, before they decide to partner prior to the PDUFA date. We have received two CRLs in the past and it is to be expected that partners would be a little gun-shy. However, potential partners are also keenly aware that the FDA has gone over Afrezza with a fine tooth comb. The FDA have issued their concerns and recommendations. We implemented their recommendation and addressed their concerns in our latest trials and then went on to achieve stellar results. Everyone is aware of this including potential partners.

      The 74-day letter represents the last stumbling block for a potential partner. Once this hurdle is cleared the game is on. I would not be surprised to see a bidding war for a piece of MannKind. In the past the 74-day letter was essentially a non-issue. This time it represents the last major hurdle before inevitable success. JMHO.

      Sentiment: Strong Buy

    • KKobe, this is the first time I've heard of it too but Matt wasn't the only one to mention it. Al and Hakan also brought it up. For some reason they are making a bigger deal of it this time.

      Cory Kasimov - JPMorgan
      Thanks for taking questions. First of all, has the FDA given you any indications at this point whether or not they may want to host a panel?
      Alfred Mann - Chairman of the Board, Chief Executive Officer
      No. There has been no indication at this point in time. The earliest time we would expect to see that if again against our belief right now would have to look probably be conjunction with this 74 Day letter.

      We expect additional FDA feedback on our application shortly after the filing or as part of the Day 74 letter later thus everything is on track and proceeding according to the usual regulatory timeline. Should the 74 Day have significantly changed any of the planning assumptions for their efforts of submission, we will of course share such material information with you.

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