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Post by liane on Oct 17, 2013 19:07:07 GMT -5
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Post by liane on Oct 17, 2013 19:23:09 GMT -5
Good interview; knowledgeable interviewer.
Al made a comment that 1 patient had ~ half of the hypoglycemia events - and that they are investigating that now.
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Post by liane on Oct 17, 2013 19:29:49 GMT -5
Also made a comment that by dosing Lantus once a day instead of twice a day, it adds ~.5% to the HbA1c. But the FDA wouldn't allow a BID dosing for this study as Lantus' label is written once a day. Thus the 171 study didn't get as many patients under 7% as anticipated.
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Post by liane on Oct 17, 2013 19:33:58 GMT -5
Matt mentioned ~ 14 M warrants came in just yesterday.
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Post by nemzter on Oct 17, 2013 21:09:41 GMT -5
Good interview; knowledgeable interviewer. Al made a comment that 1 patient had ~ half of the hypoglycemia events - and that they are investigating that now. Hmmmm... now doesn't that sound familiar? Start @ 8:27 www.youtube.com/watch?v=dL892eus81M |
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Post by u1682002 on Oct 18, 2013 0:39:19 GMT -5
Good interview; knowledgeable interviewer. Al made a comment that 1 patient had ~ half of the hypoglycemia events - and that they are investigating that now. Do you see this as a concern? Can this be used in any way to against MNKD's approval? Of course I can see this could turn out to be good news if this data point can somehow be removed. |
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Post by liane on Oct 18, 2013 7:38:22 GMT -5
Good interview; knowledgeable interviewer. Al made a comment that 1 patient had ~ half of the hypoglycemia events - and that they are investigating that now. Hmmmm... now doesn't that sound familiar? Start @ 8:27 www.youtube.com/watch?v=dL892eus81MGood catch nemzter! |
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Post by liane on Oct 18, 2013 7:40:56 GMT -5
Good interview; knowledgeable interviewer. Al made a comment that 1 patient had ~ half of the hypoglycemia events - and that they are investigating that now. Do you see this as a concern? Can this be used in any way to against MNKD's approval? Of course I can see this could turn out to be good news if this data point can somehow be removed. I'm not concerned. It shouldn't be anything to be used against MNKD. Neither do I think the data point can be "removed". I do think it adds "color" to the results - especially if they can figure out why. |
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Post by notamnkdmillionaire on Oct 18, 2013 8:33:46 GMT -5
Do you see this as a concern? Can this be used in any way to against MNKD's approval? Of course I can see this could turn out to be good news if this data point can somehow be removed. I'm not concerned. It shouldn't be anything to be used against MNKD. Neither do I think the data point can be "removed". I do think it adds "color" to the results - especially if they can figure out why. I wouldn't be concerned either. In fact, I would think it's a GOOD thing that it was only ONE who had the most as that one is the outlier that skews the data horrendously. Removing that one patient and focusing on the others should strengthen Afrezza's case. Now, it is important to figure out why that one person was having so many and to rule out Afrezza as the cause. No drug works perfectly for everyone but hopefully the company can figure out why this one person was susceptible to numberous hypos. |
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Post by notamnkdmillionaire on Oct 18, 2013 8:34:29 GMT -5
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Post by nemzter on Oct 18, 2013 11:59:20 GMT -5
I'm not concerned. It shouldn't be anything to be used against MNKD. Neither do I think the data point can be "removed". I do think it adds "color" to the results - especially if they can figure out why. I wouldn't be concerned either. In fact, I would think it's a GOOD thing that it was only ONE who had the most as that one is the outlier that skews the data horrendously. Removing that one patient and focusing on the others should strengthen Afrezza's case. Now, it is important to figure out why that one person was having so many and to rule out Afrezza as the cause. No drug works perfectly for everyone but hopefully the company can figure out why this one person was susceptible to numberous hypos. I just found it odd that Al stated that he wanted to know more about this single individual. They already submitted the NDA! Or is submission of the NDA separate from submission of the data? They should have at least some information as to why this single patient had the most hypo events, since the FDA would be asking them the same question once they start reviewing the data. |
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