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Insmed Incorporated Message Board

  • insm_truth_teller insm_truth_teller Feb 28, 2013 8:13 AM Flag

    Dog study

    by restrainedmagic

    This is not an academic endeavor by INSM. It is a mandatory safety study required by the FDA (EMEA did not require this study) for final regulatory approval to clarify a "questionable finding that INSM reported to the FDA" following a two year rat study. If it was an academic study, they could get the results and submit an abstract to any number of scientific journels at any time. But it is a regulatory piece of evidence that must be reviewed first by the FDA under the terms of confidentiality associated with the IND to determine that it answered the FDA concerns associated with the rat study. Any prior submission to a third party would be a breach of regulatory protocol and would not be viewed favorably by the FDA. Case in point, the PJ Garvin study with JS and RW on DEHP (1975) was accepted academically by the Journal of Tox and Applied Pharm, but had to be redone at Baxter Travenol because the first group of 20 rats was injected with serum control for 28 days, the second was injected with low dose, the third with intermediate dose and the fourth with the high dose. The animals were phased this way because of the elaborate process of analyzing 20 rats in a group took While academic journels do not investigate the protocols that carefully, the FDA landed on the submission by saying the "control and treatment groups were confounded in time." That means that the first groups results are not related to the last groups results because the conditions, feed, water, environment, etc. may have varied between the groups causing different results. We had to perform this study all over again by placing 5 animals in each group on study at the same time and then repeating the testing pattern four times. There were still 20 animals in each group, but they were matched among all groups. Needless to say, the reaults were the same. DEHP did not leach out into rat plasma enough to reach the toxic threshold.

    So if INSM breaks any news on the dog study, investors can be sure that the FDA has seen the data first and concurs that there is no problem. Which has been my contention all along based on the resiliency of dog lungs and their large anatomical size. But it shows that the FDA (or any Federal regulatory agency) will exercise the "first right of refusal of data" and send a company back to perform another very expensive study or group of studies to provide an answer concerning any "questionable finding." That is the regulatory process. Remember all the preclinical safety studies have to be performed according to another regulatory standard GLP (Good Laboratory Practice).

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    • by restrainedmagic

      This is not an academic endeavor by INSM. It is a mandatory safety study required by the FDA (EMEA did not require this study) for final regulatory approval to clarify a "questionable finding that INSM reported to the FDA" following a two year rat study. If it was an academic study, they could get the results and submit an abstract to any number of scientific journels at any time. But it is a regulatory piece of evidence that must be reviewed first by the FDA under the terms of confidentiality associated with the IND to determine that it answered the FDA concerns associated with the rat study. Any prior submission to a third party would be a breach of regulatory protocol and would not be viewed favorably by the FDA. Case in point, the PJ Garvin study with JS and RW on DEHP (1975) was accepted academically by the Journal of Tox and Applied Pharm, but had to be redone at Baxter Travenol because the first group of 20 rats was injected with serum control for 28 days, the second was injected with low dose, the third with intermediate dose and the fourth with the high dose. The animals were phased this way because of the elaborate process of analyzing 20 rats in a group took While academic journels do not investigate the protocols that carefully, the FDA landed on the submission by saying the "control and treatment groups were confounded in time." That means that the first groups results are not related to the last groups results because the conditions, feed, water, environment, etc. may have varied between the groups causing different results. We had to perform this study all over again by placing 5 animals in each group on study at the same time and then repeating the testing pattern four times. There were still 20 animals in each group, but they were matched among all groups. Needless to say, the reaults were the same. DEHP did not leach out into rat plasma enough to reach the toxic threshold.

      So if INSM breaks any news on the dog study, investor

      • 2 Replies to insm_truth_teller
      • by restrainedmagic

        This is not an academic endeavor by INSM. It is a mandatory safety study required by the FDA (EMEA did not require this study) for final regulatory approval to clarify a "questionable finding that INSM reported to the FDA" following a two year rat study. If it was an academic study, they could get the results and submit an abstract to any number of scientific journels at any time. But it is a regulatory piece of evidence that must be reviewed first by the FDA under the terms of confidentiality associated with the IND to determine that it answered the FDA concerns associated with the rat study. Any prior submission to a third party would be a breach of regulatory protocol and would not be viewed favorably by the FDA. Case in point, the PJ Garvin study with JS and RW on DEHP (1975) was accepted academically by the Journal of Tox and Applied Pharm, but had to be redone at Baxter Travenol because the first group of 20 rats was injected with serum control for 28 days, the second was injected with low dose, the third with intermediate dose and the fourth with the high dose. The animals were phased this way because of the elaborate process of analyzing 20 rats in a group took While academic journels do not investigate the protocols that carefully, the FDA landed on the submission by saying the "control and treatment groups were confounded in time." That means that the first groups results are not related to the last groups results because the conditions, feed, water, environment, etc. may have varied between the groups causing different results. We had to perform this study all over again by placing 5 animals in each group on study at the same time and then repeating the testing pattern four times. There were still 20 animals in each group, but they were matched among all groups. Needless to say, the reaults were the same. DEHP did not leach out into rat plasma enough to reach the toxic threshold.

      • by restrainedmagic

        This is not an academic endeavor by INSM. It is a mandatory safety study required by the FDA (EMEA did not require this study) for final regulatory approval to clarify a "questionable finding that INSM reported to the FDA" following a two year rat study. If it was an academic study, they could get the results and submit an abstract to any number of scientific journels at any time. But it is a regulatory piece of evidence that must be reviewed first by the FDA under the terms of confidentiality associated with the IND to determine that it answered the FDA concerns associated with the rat study. Any prior submission to a third party would be a breach of regulatory protocol and would not be viewed favorably by the FDA. Case in point, the PJ Garvin study with JS and RW on DEHP (1975) was accepted academically by the Journal of Tox and Applied Pharm, but had to be redone at Baxter Travenol because the first group of 20 rats was injected with serum control for 28 days, the second was injected with low dose, the third with intermediate dose and the fourth with the high dose. The animals were phased this way because of the elaborate process of analyzing 20 rats in a group took While academic journels do not investigate the protocols that carefully, the FDA landed on the submission by saying the "control and treatment groups were confounded in time." That means that the first groups results are not related to the last groups results because the conditions, feed, water, environment, etc. may have varied between the groups causing different results. We had to perform this study all over again by placing 5 animals in each group on study at the same time and then repeating the testing pattern four times. There were still 20 animals in each group, but they were matched among all groups. Needless to say, the reaults were the same. DEHP did not leach out into rat plasma enough to reach the toxic threshold.

        So if INSM breaks any news on the dog study, investo

 
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