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Post by mnholdem on Oct 6, 2015 14:21:53 GMT -5
This is primarily a PK profile study in type 1. Not sure if it will be used to change the label. For sure it will not alter the label for type 2 DM use. Lot of newbies here (i.e. docrezza registered 52 minutes ago, welcome by the way) may not know or remember the quote by the FDA related to this test that has been posted here about six times:
"Conduct a dose-ranging PK-PD euglycemic glucose-clamp trial to characterize the dose-response of Afrezza relative to subcutaneous insulin in patients with type 1 diabetes. Select at least three to four doses for each route of insulin administration to ensure both the linear and curvilinear portions of the dose-response curves are adequately captured and characterized. Compare the dose-response curves for Afrezza and subcutaneous insulin noting the dose at which the response becomes curvilinear for each. These data may impact labeling recommendations for dosing and thereby mitigate the risk of diabetic ketoacidosis, which has been observed with Afrezza."
If the FDA has determined that this trial may affect the label - and has published their opinion - that is good enough for me. Hence my earlier statement that Sanofi may be chatting with the FDA if the trial results are great. Does anyone here think they won't be now that Sanofi is in charge of development?
www.accessdata.fda.gov/scripts/cder/pmc/index.cfm
Note: At the linked site, you must enter "Afrezza" in the PRODUCT field and click Search to get to the correct page listing the post-marketing trial requirements and the statement above. I cannot get a direct link to work...
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Post by mnholdem on Oct 6, 2015 14:41:15 GMT -5
Looks like only 30 participants in the study. Hopefully that will be enough for a label change. Small sample size, though... Briefly glanced at it... does anyone know where to find the results of the study? The pediatric study is slated for an enrollment of only 46, which also surprises me, but the FDA and Sanofi must know what is needed to be considered empirical evidence. |
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Post by bradleysbest on Oct 6, 2015 14:44:31 GMT -5
That has been Matt's reply to several questions at conferences about Afrezza, etc.... A lil humor folks
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Post by gwb on Oct 6, 2015 14:46:54 GMT -5
This is primarily a PK profile study in type 1. Not sure if it will be used to change the label. For sure it will not alter the label for type 2 DM use. docfrezza welcome to the board . I have found great value in your REAL WORLD posts from the yahoo message board . I hope you continue to post here on proboards . GWB |
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Post by centralcoastinvestor on Oct 6, 2015 14:50:40 GMT -5
Looks like only 30 participants in the study. Hopefully that will be enough for a label change. Small sample size, though... Briefly glanced at it... does anyone know where to find the results of the study? The pediatric study is slated for an enrollment of only 46, which also surprises me, but the FDA and Sanofi must know what is needed to be considered empirical evidence. The larger studies utilize more people to determine the overall safety of a product and possible side effects on a lager population. That has been done for Afrezza. It takes far less people to determine dosing characteristics and how the body responds to those doses. With CGMs recording the response to Afrezza, I don't see why the FDA couldn't change the label. Particularly if the results are as good as first users are finding. |
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Post by centralcoastinvestor on Oct 6, 2015 14:53:46 GMT -5
This is primarily a PK profile study in type 1. Not sure if it will be used to change the label. For sure it will not alter the label for type 2 DM use. Hi Doc. I am assuming you are the same docfrezza from the YMB. If you are, welcome aboard. I have really enjoyed your factual updates on the YMB and I am sure all the posters here on Proboards would love to hear your posts from the "real world." |
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Post by docfrezza on Oct 6, 2015 15:18:29 GMT -5
Yes, I am the same as on YMB. Thanks for the warm welcomes. Just learning my way around here.
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Post by Chris-C on Oct 6, 2015 16:16:25 GMT -5
Yes, I am the same as on YMB. Thanks for the warm welcomes. Just learning my way around here. Welcome DocFrezza. In the past, this has been a very good board, with many longtime investors who know the product and the company and have done thorough due diligence. Lately, there have been many newcomers, who have yet to establish that they are not here to simply bash the stock. No one here wants a Yahoo type circus, so the moderators have reminded newbies of the rules. Because of the silence from the company and success of the shorts and miscreants in driving the share price down, even some of the longstanding posters here have gotten sarcastic and negative, with several making a hobby out of bashing the MNKD leadership team. Others of us believe the executive team has been focused on executing their own particular responsibilities and not worried about things over which they have no control (such as the share price). I'm always surprised at the criticism directed toward Mannkind for activities that have been placed under Sanofi's areas of responsibility. In life, for many, unresolved suffering leads to violence. In investing, for many, unimproved share prices leads to bashing. Clearly, people in Mannkind and Sanofi are working hard at their assigned jobs. There is abundant evidence of this, and in time, I believe it will yield results (and changes in the share price). A SNY responsibility, the required T1 clamp study has been bashed because of sample size. As you may know, designs of clinical research are powered to enable the statistical demonstration of valid findings with the minimum number of subjects necessary to produce statistically significant findings with achievable differences in the variables being measured. This reduces cost and complexity. In my experience, 30 subjects is often this threshold. So, I'm satisfied, since why do a study with more cost and complexity than is required to answer the questions? I hope you benefit from the board. Chris C |
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Post by factspls88 on Oct 6, 2015 16:21:22 GMT -5
This is primarily a PK profile study in type 1. Not sure if it will be used to change the label. For sure it will not alter the label for type 2 DM use. Hi Doc. I am assuming you are the same docfrezza from the YMB. If you are, welcome aboard. I have really enjoyed your factual updates on the YMB and I am sure all the posters here on Proboards would love to hear your posts from the "real world." Good to see you doc. Like centralcoast, I appreciate your insights. |
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Post by roseylv on Oct 6, 2015 17:45:45 GMT -5
Yes, I am the same as on YMB. Thanks for the warm welcomes. Just learning my way around here. Welcome DocFrezza. In the past, this has been a very good board, with many longtime investors who know the product and the company and have done thorough due diligence. Lately, there have been many newcomers, who have yet to establish that they are not here to simply bash the stock. No one here wants a Yahoo type circus, so the moderators have reminded newbies of the rules. Because of the silence from the company and success of the shorts and miscreants in driving the share price down, even some of the longstanding posters here have gotten sarcastic and negative, with several making a hobby out of bashing the MNKD leadership team. Others of us believe the executive team has been focused on executing their own particular responsibilities and not worried about things over which they have no control (such as the share price). I'm always surprised at the criticism directed toward Mannkind for activities that have been placed under Sanofi's areas of responsibility. In life, for many, unresolved suffering leads to violence. In investing, for many, unimproved share prices leads to bashing. Clearly, people in Mannkind and Sanofi are working hard at their assigned jobs. There is abundant evidence of this, and in time, I believe it will yield results (and changes in the share price). A SNY responsibility, the required T1 clamp study has been bashed because of sample size. As you may know, designs of clinical research are powered to enable the statistical demonstration of valid findings with the minimum number of subjects necessary to produce statistically significant findings with achievable differences in the variables being measured. This reduces cost and complexity. In my experience, 30 subjects is often this threshold. So, I'm satisfied, since why do a study with more cost and complexity than is required to answer the questions? I hope you benefit from the board. Chris C Chris, I was purely speculating on what was going to be brought up at Thursday's investment forum. I certainly hope that Aegis capital has a biotech expert who understands what is required of a biotech company with regards to a clamp study? I feel as though, if they have a rookie analyst asking questions, the sample set question could arise. All that being said the clamp study result may certainly not even come to light tomorrow. p.s I will try and keep my speculation to a minimum moving forward! |
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Post by harrys on Oct 6, 2015 17:59:20 GMT -5
Welcome DocFrezza. In the past, this has been a very good board, with many longtime investors who know the product and the company and have done thorough due diligence. Lately, there have been many newcomers, who have yet to establish that they are not here to simply bash the stock. No one here wants a Yahoo type circus, so the moderators have reminded newbies of the rules. Because of the silence from the company and success of the shorts and miscreants in driving the share price down, even some of the longstanding posters here have gotten sarcastic and negative, with several making a hobby out of bashing the MNKD leadership team. Others of us believe the executive team has been focused on executing their own particular responsibilities and not worried about things over which they have no control (such as the share price). I'm always surprised at the criticism directed toward Mannkind for activities that have been placed under Sanofi's areas of responsibility. In life, for many, unresolved suffering leads to violence. In investing, for many, unimproved share prices leads to bashing. Clearly, people in Mannkind and Sanofi are working hard at their assigned jobs. There is abundant evidence of this, and in time, I believe it will yield results (and changes in the share price). A SNY responsibility, the required T1 clamp study has been bashed because of sample size. As you may know, designs of clinical research are powered to enable the statistical demonstration of valid findings with the minimum number of subjects necessary to produce statistically significant findings with achievable differences in the variables being measured. This reduces cost and complexity. In my experience, 30 subjects is often this threshold. So, I'm satisfied, since why do a study with more cost and complexity than is required to answer the questions? I hope you benefit from the board. Chris C Chris, I was purely speculating on what was going to be brought up at tomorrow investment forum. I certainly hope that Aegis capital has a biotech expert who understands what is required of a biotech company with regards to a clamp study? I feel as though, if they have a rookie analyst asking questions, the sample set question could arise. All that being said the clamp study result may certainly not even come to light tomorrow. p.s I will try and keep my speculation to a minimum moving forward! I think the conference is Thurs. Oct 8th? |
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Post by vestful on Oct 6, 2015 18:00:49 GMT -5
Aegis Capital Corp. 2015 Growth Conference on Thursday, October 8, 2015 at 9:30 am Pacific Time at the Encore at the Wynn Hotel in Las Vegas, Nevada.
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Post by kball on Oct 6, 2015 19:13:40 GMT -5
Get Zeig back to vegas stat!
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Post by compound26 on Nov 16, 2015 20:00:27 GMT -5
Anyone has an update on the results of this study and the potential use of the results (and data collected)?
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Post by peppy on Nov 16, 2015 20:11:59 GMT -5
Anyone has an update on the results of this study and the potential use of the results (and data collected)? |
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