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Insmed Incorporated Message Board

  • alazoner alazoner Mar 27, 2014 2:30 AM Flag

    Biowatchdog comments last night

    Three post about results yesterday. al

    "BUY! I would not be at all surprised if this goes down, so buy. Long and the short is that the secondary was the ultimate goal but they chose not pursue as the primary because they thought there was no-way they could hit it; but, they did! Negative cultures after 84 days on a time-released treatment. Let the bashers bash and buy if you can. And by the way…I predict the FDA will accept this and we will see a combined submission to the EMA.
    REPEAT!l. BUY!

    MAC conversion occurs at 120 days. If you did not hear it on the call, listen again. The first conversions were seen at the first month! So, at 30 days we have "cure" in some of the most difficult NTM pop. Also, it continues...in the open label extension they are seeing continued conversion! The "cure" rate is greater than 25%. Stay tuned!

    Can you tell I am excited?
    No. In fact, if you listen carefully to the call, the FDA required conversion as the primary, so the design was actually inclusive of the secondary with the primary scale and as a the key secondary. The FDA will evaluate based on both together, in parallel. Sort of like zooming in on the thing the FDA really cared about. And if you listen to the clinicians, the secondary is what they cared about too! If I had heard these guys before the trial ended, I would have thought there was no way this would succeed. Conversion is the key and they all felt there was no way to get there. What a wonderful, pleasant surprise! That is what they will discuss with the FDA."

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    • "BUY! I would not be at all surprised if this goes down, so buy. Long and the short is that the secondary was the ultimate goal but they chose not pursue as the primary because they thought there was no-way they could hit it; but, they did! Negative cultures after 84 days on a time-released treatment. Let the bashers bash and buy if you can. And by the way…I predict the FDA will accept this and we will see a combined submission to the EMA.
      REPEAT!l. BUY!

      MAC conversion occurs at 120 days. If you did not hear it on the call, listen again. The first conversions were seen at the first month! So, at 30 days we have "cure" in some of the most difficult NTM pop. Also, it continues...in the open label extension they are seeing continued conversion! The "cure" rate is greater than 25%. Stay tuned!

      Can you tell I am excited?
      No. In fact, if you listen carefully to the call, the FDA required conversion as the primary, so the design was actually inclusive of the secondary with the primary scale and as a the key secondary. The FDA will evaluate based on both together, in parallel. Sort of like zooming in on the thing the FDA really cared about. And if you listen to the clinicians, the secondary is what they cared about too! If I had heard these guys before the trial ended, I would have thought there was no way this would succeed. Conversion is the key and they all felt there was no way to get there. What a wonderful, pleasant surprise! That is what they will discuss with the FDA.

    • Thank you Alberto.
      "BUY! I would not be at all surprised if this goes down, so buy. Long and the short is that the secondary was the ultimate goal but they chose not pursue as the primary because they thought there was no-way they could hit it; but, they did! Negative cultures after 84 days on a time-released treatment. Let the bashers bash and buy if you can. And by the way…I predict the FDA will accept this and we will see a combined submission to the EMA.
      REPEAT!l. BUY!

      MAC conversion occurs at 120 days. If you did not hear it on the call, listen again. The first conversions were seen at the first month! So, at 30 days we have "cure" in some of the most difficult NTM pop. Also, it continues...in the open label extension they are seeing continued conversion! The "cure" rate is greater than 25%. Stay tuned!

      Can you tell I am excited?
      No. In fact, if you listen carefully to the call, the FDA required conversion as the primary, so the design was actually inclusive of the secondary with the primary scale and as a the key secondary. The FDA will evaluate based on both together, in parallel. Sort of like zooming in on the thing the FDA really cared about. And if you listen to the clinicians, the secondary is what they cared about too! If I had heard these guys before the trial ended, I would have thought there was no way this would succeed. Conversion is the key and they all felt there was no way to get there. What a wonderful, pleasant surprise! That is what they will discuss with the FDA."

    • Here is the link to biowatchdog comments. al

    • thread of the day that will not be deleted. al

    • Good Morning. I wanted to make sure information post do not get erased. Follow the link to see what biowatchdog wrote last night. al

    • This is the info that I hope rises to the top in the days and weeks to come

 
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