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Insmed Incorporated Message Board

  • sigma_capitals sigma_capitals Jun 18, 2014 10:08 PM Flag

    +++ What You Need to Know About Breakthrougth Designation +++

    According to FDA's own website, from Oct. 1, 2012 to May 31, 2014 they received 41 requests for Breakthrough designation and only approved 4 (2 other drugs are still pending). That's only 13% approval rate and making the cut says a lot about the stringency of the selection process. Yet, I say it again: YET, Arikayce was granted the coveted Breakthrough status with Phase II data. What's more interesting is the fact that NO product that has previously been granted this status has ever been rejected by the FDA for final approval. In fact, all Breakthrough products that have been approved by the FDA, only took 6-12 month for final approval and launch. Explains a lot why Insmed was on overdrive to secure manufacturing and marketing resources.

    These drugs were designated as Breakthrough and then approved by the FDA soon thereafter:

    1. Roche: Gazyva
    2. Johnson & Johnson and Pharmacyclics: Imbruvica
    3. Gilead: Sovaldi
    4. I expect soon Arikayce will join the list

    Please help keep those facts on top so people on both sides of the trade are informed.

    Sigmond

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • The fact that Novartis was granted breakthrough designation and was denied; It only shows that your argument is not true. We cannot rely on your information. There is no guarantee that INSM will be approved.

    • Arikayce has in fact joined the BT list.

    • Thanks Sigma (to the top):

      According to FDA's own website, from Oct. 1, 2012 to May 31, 2014 they received 41 requests for Breakthrough designation and only approved 4 (2 other drugs are still pending). That's only 13% approval rate and making the cut says a lot about the stringency of the selection process. Yet, I say it again: YET, Arikayce was granted the coveted Breakthrough status with Phase II data. What's more interesting is the fact that NO product that has previously been granted this status has ever been rejected by the FDA for final approval. In fact, all Breakthrough products that have been approved by the FDA, only took 6-12 month for final approval and launch. Explains a lot why Insmed was on overdrive to secure manufacturing and marketing resources.

      These drugs were designated as Breakthrough and then approved by the FDA soon thereafter:

      1. Roche: Gazyva
      2. Johnson & Johnson and Pharmacyclics: Imbruvica
      3. Gilead: Sovaldi
      4. I expect soon Arikayce will join the list

      Please help keep those facts on top so people on both sides of the trade are informed.

      Sentiment: Buy

    • liar...check seralaxin from novartis. Granted breakthrough and still rejected. This is no guarantee of approval

      Sentiment: Strong Sell

      • 1 Reply to singkumbaya
      • True but this drug should not have been granted BT designation as it did not pass all the "steps" which are now in place (see FDA BTD in May 2014). It did supposedly reduce deaths by 37% )how do you measure that?) but it caused a lot of other issues (adverse effects). Point is it should be more difficult to designate a "drug" as breakthrough so the FDA does not waste its time later - rejecting.

        Sentiment: Buy

    • Bump

      Sentiment: Buy

    • Sigma -

      This is truly a great post. Thank you

      Sentiment: Strong Buy

    • Great Info

      Sentiment: Strong Buy

    • great info

    • Excellent post sigma:

      According to FDA's own website, from Oct. 1, 2012 to May 31, 2014 they received 41 requests for Breakthrough designation and only approved 4 (2 other drugs are still pending). That's only 13% approval rate and making the cut says a lot about the stringency of the selection process. Yet, I say it again: YET, Arikayce was granted the coveted Breakthrough status with Phase II data. What's more interesting is the fact that NO product that has previously been granted this status has ever been rejected by the FDA for final approval. In fact, all Breakthrough products that have been approved by the FDA, only took 6-12 month for final approval and launch. Explains a lot why Insmed was on overdrive to secure manufacturing and marketing resources.

      These drugs were designated as Breakthrough and then approved by the FDA soon thereafter:

      1. Roche: Gazyva
      2. Johnson & Johnson and Pharmacyclics: Imbruvica
      3. Gilead: Sovaldi
      4. I expect soon Arikayce will join the list

 
INSM
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