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Insmed Incorporated Message Board

  • hubby_14508 hubby_14508 Jul 1, 2013 8:26 PM Flag

    ok folks

    today is done (ametrosixual's 1000000 posts notwithstanding).....
    so I have a simple but difficult question...
    where the eff do we go from here?
    as I said I own way too much of this and I did sell 12% of my shares today...still own over 30,000 shares...
    on the plus side we did reach our endpoint but will that be enough for the FDA...
    then we have NTM, and the fast track designation...also good.
    company also sounded VERY upbeat...
    that said, and we know its coming...dilution.....
    assuming we have a benign market, wondering what folks here think of things going forward this stage, I thought I had a handle on things...I was wrong

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    • There's one thing that strikes me. The pIII results for Arikace look nothing like pII results. The thing that was supposed to be so unique about Arikace was maintenance of improvement in lung function at the end of the off period. In pIII, we saw readings below baseline at the end of the first off period after only 28 days. How can this be explained? No one mentioned it on the call. Neither drug behaved the way that many expected them to based on prior trials. The only thing that gives me solace is that Tobi did display the downstaircase pattern in lung function improvement over baseline over 3 cycles, while the Arikace effect did not appear to deteriorate over 3 cycles. When you look at the data for FEV1 and the Ps sputum density, it's almost as if, right out of the gate, Arikace put on a bad show. How can you explain this? Bad batch? Something doesn't add up.

    • hubby...I feel ya, brother. Earlier I was thinking along the lines of tycint...and I still have some of that lingering. To wit, why the drama of the Friday PR. But, the reality is that all the news was good except we didn't have superiority. I know that is a big one, but we did get quite a few things checked off. QIDP is very big as that gives us a lot in the regulatory world. Hopefully, FDA, by granting QIDP, will acknowledge that Arikace is important and give positive consideration to this PIII data. Further, after watching today's action and settling in with a nice G&T I've come around to jad's view. Most importantly, I think we have more than a very good shot at an EMEA approval. The enthusiasm on the CC by the researchers was genuine. I've participated in one FDA drug approval hearing that I can think back to, and thinking to that I do think we'll get a fair shake by FDA because the support of people of the quality that commented today on the CC panel of researchers really does matter. Lazard's statement was very reassuring, and geoff's post about Cannacord also rings true. The drop in SP is a drag, but it is what we got handed to us today. I didn't sell anything today, but certainly understand you lessening your exposure.

      Will we drift around and see SP drop anymore? Tough to read the tea leaves. It will take some time to recoup the SP loss, but I suspect we'll be more than whole in the next 4-6 months. The G&T tells me that the only thing that happened is that the timeline got extended. The NTM trial has a good design and that is in our favor.

      What I do know is that after all this is over, and in our favor, we longs that have been here since PCOS, the patent issue and MMD need to get together and laugh - if we can :)

    • I'm not sure what you were expecting. Arikace will be a part of a rotation as was always the case. It will make no less money than TOBI in this rotation and, if it doesn't lose effectiveness at the level TOBI has exhibited it will earn much more. As a bonus, fast track, QDIP and a petition to the FDA to likely accept EMEA/Canadian results. None of this was but QDIP results were expected today. The wheels have been greased and the bus is moving.

      Sentiment: Buy

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