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MannKind Corp. Message Board

  • savzak savzak Jun 21, 2013 4:35 PM Flag

    For everyone who expects a partnership pre-approval...

    Why will it happen this time? Last time around many expected a partnership preapproval but it didn't happen. Most of us thought that Al was just driving a very hard bargain so as to realize full value.

    How do you see it differently this time? Is Al more willing to err on the side of reasonableness because of the need for financing? Are you anticipating more aggresive interest from partners due to a more expansive label?

    I know management talks as though they desire (and even expect) a partnership sooner rather than later but that was true last time as well.

    Sentiment: Strong Buy

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    • Agree...Nothing, including successful trial outcome, unobstructive FDA approval process, or partnership before approval, is a "Given" - to claim otherwise is at best simply naïve.

    • I don't expect a partnership pre-approval. If it happens, great, but it will surprise me!

      Sentiment: Strong Buy

    • Question: "Is Al more willing to err on the side of reasonableness because of the need for financing?"
      Answer: Yes. Matt has clearly stated that Al would prefer to not put new money into MNKD by tapping the line of credit. Since no explanation has been given, I take this as Al is reluctant to put new $ into MNKD. A partnership w/ some amount of up front $ protects MNKD from any hiccup w/ the PDUFA.

      Question: "Are you anticipating more aggresive interest from partners due to a more expansive label?"
      Answer: Yes. Even if type 2 is not approved, just knowing where the FDA stands, and thus what it would take to reach approval, is valuable information to support partner value. Obviously, milestone payments will need to be tied to PDUFA outcomes, which is common.

      Sentiment: Strong Buy

    • ok buy

      Sentiment: Strong Buy

    • What's different now is that the partner believes approval will actually happen. The reason why there was no partnership before was there was no need for one - approval was iffy. Tell me this, if the fda approved Afrezza the last time, how would they have launched the product when there was no sales force at all? No sales executive, not even a single salesperson. They would have launched 1 year later which is unheard off.

      • 4 Replies to bbarra1
      • bbarra, I agree. This is the point I've made many times. Twice now, prospective partners were willing to wait until post-approval. For those buying mgmt's buhlchit that they're "waiting" until post data, I'd frame it more as "hoping" that partnership happens post data. ....they sure love to spin the situation.

        i frankly still don't think we get a partnership until post approval and if it happens sooner, great!

      • I got all that. If approved, the ramp was going to take awhile. We talked about that issue alot at the time. But did you know then that the potential partners thought approval was "iffy"? I didn't. How do you know the partners don't think approval is iffy now?

        Sentiment: Strong Buy

      • Ever heard of Arna?

      • Just to make it clear, for people that don't know what "salesforce" really entail. It's not just calling on and educating the doctors. It also involves signing vendors up (contracting), all the wholesalers, distributors, GPOs, HMOs, pharmacies, clinics, hospitals, etc.. Signing up all the insurers, Medicaid and Medicare. This whole process including what pricing and discounting should be given to each type of customer takes about 6 months to 1 year. You wait for FDA approval before you start all of these activities. You would lose a whole year of revenue, a whole year of patent rights, a whole year of manufacturing overhead without selling anything. Worst, you will give your competitor 1 year of time to catch up.

 
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