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Post by dreamboatcruise on Apr 25, 2018 18:21:55 GMT -5
Folklore has it Dr. Kendall once wrestled a grizzly bear with one hand tied behind his back while dictating an abstract for an ADA presentation. That one is just too crazy to not be true  While eating a mallomar that Spiro gave him. I saw the youtube video and it was epic! And I heard at one trade show he picked up two cases of mallomars and leapt over an entire 20x20 booth in a single bound in order to illustrate what a glucose spike is to an endo that didn't understand. |
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Post by sportsrancho on Apr 25, 2018 18:35:30 GMT -5
While eating a mallomar that Spiro gave him. I saw the youtube video and it was epic! And I heard at one trade show he picked up two cases of mallomars and leapt over an entire 20x20 booth in a single bound in order to illustrate what a glucose spike is to an endo that didn't understand. That’s hilarious 😂 |
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Post by mnholdem on Apr 25, 2018 20:16:05 GMT -5
That whole thing was staged long ago. David only trained the bear to make it look like he was in peril, in order to impress a young nurse (now his wife). I hear he's been training another bear at his cabin in northern Minnesota to impress his children on how tough he is. I think he's also planning to invite his daughter's new boyfriend to scare the crap out of him. I think he wants her to marry a doctor.  |
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Post by dreamboatcruise on Apr 26, 2018 0:51:40 GMT -5
That whole thing was staged long ago. David only trained the bear to make it look like he was in peril, in order to impress a young nurse (now his wife). I hear he's been training another bear at his cabin in northern Minnesota to impress his children on how tough he is. I think he's also planning to invite his daughter's new boyfriend to scare the crap out of him. I think he wants her to marry a doctor. "Stage right... is that my right or your right?" "I'm stressed about trying to motivate this 'angry' thing. 'Grrrr!'... just doesn't... feel right. I've had a pretty good life for a bear... not sure what I should pull from. Could I just do sad? If I think about The Champ, I can usually cry." |
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Post by goyocafe on Apr 26, 2018 17:41:59 GMT -5
How many sNDAs has MNKD submitted since the label change last year? It seems the ones related to the REMS flew under everyone’s radar until they spotted the FDA letter. Do they always show up on a website?
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Post by mnholdem on Apr 26, 2018 19:12:26 GMT -5
No. I think prior to the last label upgrade, I posted the FDA/CDER reply to my email asking your question. The FDA reports sNDA approvals but not applications. Publicizing those are at the discretion of the applicants. I suppose most companies prefer to keep applications confidential, especially if they think eventual approval will give them some strategic advantage over competitors.
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Post by goyocafe on Apr 26, 2018 19:13:56 GMT -5
No. I think prior to the last label upgrade, I posted the FDA/CDER reply to my email asking your question. The FDA reports sNDA approvals but not applications. Publicizing those are at the discretion of the applicants. Doesn’t that make you wonder what’s been submitted? |
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Post by centralcoastinvestor on Apr 26, 2018 19:23:11 GMT -5
No. I think prior to the last label upgrade, I posted the FDA/CDER reply to my email asking your question. The FDA reports sNDA approvals but not applications. Publicizing those are at the discretion of the applicants. Doesn’t that make you wonder what’s been submitted? With the shenanigans that happened at the FDA during the first and second CRLs and the fierce competition MannKind is facing from the established BPs, I would not tell a soul what I had up my sleeve. My hope is that the STAT study is sound enough along with all of the 60 or more older studies that they can apply to have the label upgraded to Ultra Fast Acting. We will see. |
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Post by mnholdem on Apr 26, 2018 19:38:59 GMT -5
Do I wonder if other sNDA applications are being reviewed or appealed? Of course! Especially after Kendall's remarks about MannKind having years of archived trial data. His reference of available lung scan data, for example, prompted me to post my thought that Kendall may consult with the FDA to use both archived and real world data to shorten the duration of the 5-Yr Post-Market Safety Trial. There could be any number of sNDA applications being reviewed or being prepared. The lifting if the REMS program may be only the first of several surprises.
For example, what if Dr. Kendall is working with the FDA, and has other KOLs helping him, to reconsider their stance on a previous sNDA requesting a new class of "ultra rapid-acting" insulin? Do you think it would provide a strategic advantage to MannKind if approved for Afrezza? You bet! By keeping it under wraps, if an appeal of an FDA decision is not successful, you don't have to contend with short camp pundits throwing it in your face OR reporting that Fiasp is the only "ultra" when, in fact, it has never been given that classification by the FDA.
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Post by goyocafe on Apr 26, 2018 19:45:35 GMT -5
Do I wonder if other sNDA applications are being reviewed or appealed? Of course! Especially after Kendall's remarks about MannKind having years of archived trial data. His reference of lung scan data, for example, prompted me to post my thought the Kendall may consult with the FDA to use both archived and real world data to shorten the duration of the 5-Yr Post-Market Safety Trial. There could be any number of sNDA applications being reviewed or being prepared. The lifting if the REMS program may be only the first of several surprises. For example, what if Dr. Kendall is working with the FDA, and has other KOLs helping him, to reconsider their stance on a previous sNDA requesting a new class of "ultra rapid-acting" insulin? Do you think it would provide a strategic advantage to MannKind if approved for Afrezza? You bet! If an appeal of an FDA decision is not successful, you don't have short camp pundits throwing it in your face. Considering the fact that the FDA uses KOLs and advisory committees to assist in their decision making, any negative influences may be diminished by a strong data set and commentaries from Dr Kendall and others. I have been at this crossroad before, but feel there may be more momentum behind these last few months, irrespective of the stock price. |
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Post by dreamboatcruise on Apr 26, 2018 20:03:04 GMT -5
Doesn’t that make you wonder what’s been submitted? With the shenanigans that happened at the FDA during the first and second CRLs and the fierce competition MannKind is facing from the established BPs, I would not tell a soul what I had up my sleeve. My hope is that the STAT study is sound enough along with all of the 60 or more older studies that they can apply to have the label upgraded to Ultra Fast Acting. We will see. They've already provided sound data on having the fastest pk/pd profile... and it was approved by FDA and included in prescribing lit. It's just that the FDA doesn't appear to yet want to define whether a new designation/class is needed and if so what the threshold for qualifying should be. I don't think any new data from STAT or otherwise would change whether/when FDA will decide on a new designation. |
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Post by centralcoastinvestor on Apr 26, 2018 20:07:54 GMT -5
With the shenanigans that happened at the FDA during the first and second CRLs and the fierce competition MannKind is facing from the established BPs, I would not tell a soul what I had up my sleeve. My hope is that the STAT study is sound enough along with all of the 60 or more older studies that they can apply to have the label upgraded to Ultra Fast Acting. We will see. They've already provided sound data on having the fastest pk/pd profile... and it was approved by FDA and included in prescribing lit. It's just that the FDA doesn't appear to yet want to define whether a new designation/class is needed and if so what the threshold for qualifying should be. I don't think any new data from STAT or otherwise would change whether/when FDA will decide on a new designation. It appears like there are a lot of moving parts in the diabetes world right now with CGMs becoming more and more accepted. Maybe the STAT study can show what an Ultra-Rapid Acting insulin can do and this will help turn the tides on a new designated class of insulin. |
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Post by goyocafe on Apr 26, 2018 20:18:15 GMT -5
With the shenanigans that happened at the FDA during the first and second CRLs and the fierce competition MannKind is facing from the established BPs, I would not tell a soul what I had up my sleeve. My hope is that the STAT study is sound enough along with all of the 60 or more older studies that they can apply to have the label upgraded to Ultra Fast Acting. We will see. They've already provided sound data on having the fastest pk/pd profile... and it was approved by FDA and included in prescribing lit. It's just that the FDA doesn't appear to yet want to define whether a new designation/class is needed and if so what the threshold for qualifying should be. I don't think any new data from STAT or otherwise would change whether/when FDA will decide on a new designation. Wasn’t that last opinion rendered based on the clamp study alone? Now there’s a new, highly respected CMO, a STAT study (albeit a small sample size), and a living standards of care recently published by the ADA identifying other measures than A1c for measuring positive treatment outcomes, or the possibility of adding them. Seems there’s a growing swell of data/activity that might add credence to this request being reconsidered. Oh yeah, there’s always an element of hope in this line of thinking until it happens. I hope I’m still in the stock the day if and when the FDA sends another letter like this week approving such a change. |
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Post by mango on Apr 26, 2018 20:54:52 GMT -5
They've already provided sound data on having the fastest pk/pd profile... and it was approved by FDA and included in prescribing lit. It's just that the FDA doesn't appear to yet want to define whether a new designation/class is needed and if so what the threshold for qualifying should be. I don't think any new data from STAT or otherwise would change whether/when FDA will decide on a new designation. It appears like there are a lot of moving parts in the diabetes world right now with CGMs becoming more and more accepted. Maybe the STAT study can show what an Ultra-Rapid Acting insulin can do and this will help turn the tides on a new designated class of insulin. That's what I am thinking too. Afrezza and Aspart are both classified as rapid acting insulins so according to FDA they should both deliver similar results, correct? What STAT will reveal is that is incorrect: #1 Afrezza physiologically mimics endogenous human insulin secretion, it is not even "ultra rapid" it is simply providing the same insulin any other person without diabetes has and mimicking the first-phase release that is lost. Afrezza mimics human insulin because it is human insulin. Is does what insulin does because that's what it is and what it is suppose to do. #2 Aspart is not even insulin. Proline was taken out of the B28 position and replaced with aspartic acid which does not even exist in neither A nor B chains of human insulin amino acid sequences. It does not mimic insulin because it is not insulin. It is an altered foreign protein. STAT is real time evidence that Afrezza mimics endogenous insulin secretion. |
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Post by dreamboatcruise on Apr 26, 2018 21:21:15 GMT -5
It appears like there are a lot of moving parts in the diabetes world right now with CGMs becoming more and more accepted. Maybe the STAT study can show what an Ultra-Rapid Acting insulin can do and this will help turn the tides on a new designated class of insulin. That's what I am thinking too. Afrezza and Aspart are both classified as rapid acting insulins so according to FDA they should both deliver similar results, correct? What STAT will reveal is that is incorrect: #1 Afrezza physiologically mimics endogenous human insulin secretion, it is not even "ultra rapid" it is simply providing the same insulin any other person without diabetes has and mimicking the first-phase release that is lost. Afrezza mimics human insulin because it is human insulin. Is does what insulin does because that's what it is and what it is suppose to do. #2 Aspart is not even insulin. Proline was taken out of the B28 position and replaced with aspartic acid which does not even exist in neither A nor B chains of human insulin amino acid sequences. It does not mimic insulin because it is not insulin. It is an altered foreign protein. STAT is real time evidence that Afrezza mimics endogenous insulin secretion. No I don't believe that is a correct assumption. New drugs with better efficacy often are designated in the same class as older drugs that are less effective. I believe there would have to be some other reason justifying a new designation. In the case of speed of action in insulins it may be that a new designation would help with patient understanding and correct use of the product... that might be the compelling reason to create a new designation, but still the thorny issue is how does one draw the line when in reality the speed of action is a continuum. |
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