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Post by agedhippie on Jul 30, 2018 20:08:20 GMT -5
Aged - I don't know why they consolidate the DDP4 and GLP1s. I think its because its all about labeling. The lawsuit is not about the drugs killing people. The BPs already admitted to that. They just did not put it on the labels. The reality is both classes once Dr. Kendall does his job should be pulled from the market. Lilly and the FDA both thought the other GLP1s might get pulled and why they agreed to the 5 small studies to rush it to market.
The Big Dog behind the GLP-1s push is Ralph DeFronzo, the same guy who brought us metformin and who now says its the biggest waste in T2 treatment. He thinks combining GLP-1 with Actos is a great idea and short term results in the Qatar study are good and show beta cell regeneration. At the same time Ralph is talking about the SGLT-2 amputation risks. If you want to stop CVD - stop the spike and nothing does it better than afrezza. Doing it with GLP1s and TZDs are down right dangerous. If you stop the spike with afrezza you don't need the SGLT-2s to piss out the sugar.
The bottom line is if Dr. Kendall does his job which he says is the easiest job he has every had, SGLT-2s, DDP4s and GLP1s are obsoleted. But then again Lantus sales will also take a huge hit. Its just a matter of time and the question of MNKD having enough money to hang in there.
The afrezza potential risk of pulmonary malignancy with Afrezza and the warning on the label which says it has a lung cancer risk are left overs from Exubera. Pfizer did their best to poison the well. Lets see what Dr. Kendall can do to rectify this with the lost studies. The first puff was taken in 1998 and what is clear after being approved 4 years ago, no one is seeing lung issues with long time afrezza use and they won't. FDKP does not accumulate and is inert. I know "cancer" is the last thing to throw at afrezza but tree pollen is a bigger issue as is going outside in NYC smog. Nobody has said that their drugs are killing people, they have said that the label contains what they were told to put there by the FDA and labels are not discretionary - it is what the FDA says you must print. As such even if they wanted to they could not vary the label. That's why the the lawsuit was dismissed at summary judgement, the pharmas cannot vary the label. The LEADER trial killed any chance of GLP-1 getting pulled. It said that the CVD risk was not there, and that the cancer risk was so slight as to be unprovable either way. That's game over for the lawsuit (which was already in trouble having to appeal a summary judgement). Given the duration and size of the trial (over 9,000 people) it's category A evidence. The amputation risk with SGLT-2 is not a class effect, it only seems to be cause by Invokana, and as such SGLT-2 will not get pulled especially after the CREDENCE got ended early because the SGLT-2 arm was so clearly superior. The trials for Jardiance and the others (as well as CREDENCE) showed no increased amputation risk. Interestingly they are now talking about a trial to look at Invokana again to see if there were underlying causes for the last result. The Afrezza cancer risk was me being silly to make a point. Just because the FDA asks for a trial to investigate something doesn't mean it's a real risk. In this case it wasn't a left over from Exubera, but rather the lung cancer cases that turned up in the Afrezza trials. I seriously doubt there is a risk, but the FDA has to cover it to avoid a negligence lawsuit if it turns out against the odds to be real later. |
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Post by mnholdem on Jul 30, 2018 20:11:34 GMT -5
An interesting choice of words you chose in your earlier post. "Political capital" is synonymous with special interest groups that dump $$$ in various ways to influence decision makers. Your implication is that the FDA/AACE can be bought. That might be true. But influence can also be channeled through relationships with key decision makers. David Kendall and MannKind's new Scientific Advisory Board are all-stars with heavy connections to the ADA and AACE, as well as diabetes advocacy organizations. MannKind Corporation's new CMO and the SAB have the kind of influence that money alone can't buy. In addition, if the ADA/AACE feel that these heavy hitters may expose some of the questionable methods behind various inclusions into the diabetes standard of care, they will likely steer clear of money-based influence peddling. There's an old adage that "a reputation which takes years to build can be destroyed in a single day". I really hope that the ADA and AACE start being held accountable for some of their past decisions.  |
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Post by agedhippie on Jul 30, 2018 20:16:18 GMT -5
An interesting choice of words. "Political capital" is synonymous with special interest groups that dump $$$ in various ways to influence decision makers. You might very well think that; I couldn't possibly comment. (Thank you Francis Urquhart) |
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Post by mnholdem on Jul 30, 2018 20:21:06 GMT -5
An interesting choice of words. "Political capital" is synonymous with special interest groups that dump $$$ in various ways to influence decision makers. You might very well think that; I couldn't possibly comment. (Thank you Francis Urquhart) Hang on...are you calling me the "epitome of elegant evil"?  |
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Post by mnholdem on Jul 30, 2018 20:45:04 GMT -5
sayhey24
The Big Dog behind the GLP-1s push is Ralph DeFronzo, the same guy who brought us metformin and who now says its the biggest waste in T2 treatment. He thinks combining GLP-1 with Actos is a great idea and short term results in the Qatar study are good and show beta cell regeneration. At the same time Ralph is talking about the SGLT-2 amputation risks. If you want to stop CVD - stop the spike and nothing does it better than afrezza. Doing it with GLP1s and TZDs are down right dangerous. If you stop the spike with afrezza you don't need the SGLT-2s to piss out the sugar.Read more: mnkd.proboards.com/thread/10272/reality-situation#ixzz5Mn9F79aM--- Shortly after the announcement that Sanofi was ending its agreement with MannKind, I was discussing the potential of partnering with MannKind with Takeda CEO Christophe Weber. He told me that the BoD at Takeda had decided to end all further R&D in diabetes drugs. IMO, the judgement against Takeda because of multiple deaths related to Actos and the subsequent $2.4 billion settlement was the primary reason for their change in direction. As I recall, judgment stated that Takeda failed to sufficiently warn patients about the dangers of incorrectly dosing Actos45. Link: www.drugwatch.com/actos/lawsuits/Companies can try to make the argument that potential death isn't required to be on the label, but they can still be held legally accountable for withholding information about serious dangers of using their drug.
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Post by peppy on Jul 30, 2018 21:39:14 GMT -5
I should have been clearer. I think if anyone can get the ultra rapid class it is Novo Nordisk because they know how the game is played and have the political capital to get it done. Dr Kendall also knows how the game is played, but lacks the organizational political capital to get it done outright. It is going to be far easier to let Novo Nordisk do the heavy lifting and step in at the end with a me too application. The hard thing is getting a new class, the easier thing is getting into the class. Here is what I read. "I think if anyone can get the ultra rapid class it is Novo Nordisk because they can afford the pay to play. "
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Post by agedhippie on Jul 31, 2018 8:05:48 GMT -5
You might very well think that; I couldn't possibly comment. (Thank you Francis Urquhart) Hang on...are you calling me the "epitome of elegant evil"? I rather thought that was my title, but I am prepared to share |
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Post by peppy on Jul 31, 2018 8:11:08 GMT -5
Hang on...are you calling me the "epitome of elegant evil"? I rather thought that was my title, but I am prepared to share "just say no." Nancy? |
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Post by agedhippie on Jul 31, 2018 8:14:39 GMT -5
Companies can try to make the argument that potential death isn't required to be on the label, but they can still be held legally accountable for withholding information about serious dangers of using their drug. That is the case. However if they disclose the data to the FDA and the FDA does not put it on the label then they are in the clear. The problem is where they withhold data which is stupid. If the drug is good enough then the benefits outweigh the risks and people will take it regardless of the label. |
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Post by Deleted on Jul 31, 2018 8:26:08 GMT -5
Reality is that every BP with a franchise daibetes drug want to kill Afrezza. They have nothing close to our little Inhaler and deep lung penetratng insulin. While this investment is taking much longer than I would have liked, it is still the same from 6 years ago when I first invested. I love this board but too many other things in my life currently. So I am from here on out until xmas going to be more passive and let Mikey Mike and the good Dr K do their thing. And hooefully when I comw back, we be popping bottles. では、クリスマスに。よろしく。
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Post by peppy on Jul 31, 2018 8:30:03 GMT -5
Companies can try to make the argument that potential death isn't required to be on the label, but they can still be held legally accountable for withholding information about serious dangers of using their drug. That is the case. However if they disclose the data to the FDA and the FDA does not put it on the label then they are in the clear. The problem is where they withhold data which is stupid. If the drug is good enough then the benefits outweigh the risks and people will take it regardless of the label. Not death, a data point however. alrighty then. let it be known. (Just talking) AN ATYPICAL PRESENTATION OF INSULIN AMYLOIDOSIS: AN UNCOMMON BUT IMPORTANT COMPLICATION OF INSULIN THERAPY Read more: mnkd.proboards.com/thread/10051/atypical-presentation-insulin-amyloidosis?page=1#ixzz5Mq3euePb |
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Post by morgieporgie on Jul 31, 2018 8:33:41 GMT -5
That is the case. However if they disclose the data to the FDA and the FDA does not put it on the label then they are in the clear. The problem is where they withhold data which is stupid. If the drug is good enough then the benefits outweigh the risks and people will take it regardless of the label. Not death, a data point however. alrighty then. let it be known. (Just talking) AN ATYPICAL PRESENTATION OF INSULIN AMYLOIDOSIS: AN UNCOMMON BUT IMPORTANT COMPLICATION OF INSULIN THERAPY Read more: mnkd.proboards.com/thread/10051/atypical-presentation-insulin-amyloidosis?page=1#ixzz5Mq3euePb Thank you Peppy! Have a great day. |
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Post by peppy on Jul 31, 2018 8:35:53 GMT -5
Thank you Peppy! Have a great day. your point is not lost on me morgieporgie. |
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Post by morgieporgie on Jul 31, 2018 8:38:21 GMT -5
Thank you Peppy! Have a great day. your point is not lost on me morgieporgie. Somehow I knew you would understand. |
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Post by sportsrancho on Jul 31, 2018 8:50:30 GMT -5
Hang on...are you calling me the "epitome of elegant evil"? I rather thought that was my title, but I am prepared to share Interesting comment. |
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