Post by spiro on Mar 7, 2014 9:34:44 GMT -5
This Kathleen lady knows how to rip someone apart. If I were smarter, I would have said the same thing. I hopes she finds our board and starts contributing here.
Biotech Stock Mailbag Extra: MannKind's Afrezza Panel Setup - Adam's Biotech Beat - TheStreet
Kathleen • 12 hours ago
So with all those important things you are involved in (I checked "your" bio online) you found time to post on a blog in the middle of the day. Why, you even "know" that Adam has never shorted a stock. Too funny.
Kathleen • 13 hours ago
I googled him too. Perhaps someone should call Dr. Karpf to see if was actually he who posted on this blog. I have my doubts.
Kathleen • 13 hours ago
As a follow-up to my earlier post outlining my concerns with Adam's analysis, I would like to say that I expect more out of The Street than articles such as this. As an investor, I count on The Street objective, fact-based analysis with conclusions drawn from an assessment of those facts. I have no problem with contrarian opinion, so long as there are facts to back it up. And as a special note to Adam, I hope that you stick to the facts and dispense with the childish commentary as evidenced by your tweets from the JPM Conference (you know what I mean), when you blog from the FDA panel. Your readers deserve nothing less.
Kathleen • 14 hours ago
Correction - numbers 4 & 5 should be 3 & 4. Missed that in my editing.
Kathleen • 14 hours ago
Adam, as a former market strategy consultant with Fortune 500 companies, former corporate senior executive and Harvard MBA I find your case against Mannkind less than compelling and at times totally without merit. Normally, cases are made using concrete facts - and in the case of quantitative studies, using significantly significant findings, not conjecture and spin (or as they call it in the ad business, weaseling). While there are some facts in your analysis, your use of conjecture and spin intended to appear as facts is especially troubling. Let me address your case point by point.
Adam: "Maybe MannKind totally mis-read the situation and FDA always intended to convene a panel for Afrezza."
OK - what if Mannkind misread the situation? So what? Does that count against Afrezza with respect to FDA approval? Your use of the word "maybe" suggests that you really don't know the facts which, in this case, if they existed, are irrelevant.
Adam: "Or, maybe some time between last fall and January, MannKind received feedback from the FDA suggesting the agency had serious problems with the new Afrezza phase III data."
Seriously, is this what you consider fact? Again, your use the word "maybe" demonstrates pure conjecture on your part. In fact, it seems like a blatant attempt to foster serious misgivings about Afrezza's phase III data. Where is your proof? Feel free to provide it. There are many who have serious money invested in Afrezza who deserve to know.
Adam: "In Type 1 diabetics, Afrezza was numerically worse than Novo Nordisk's (NVO) Novolog."
Interesting that you had to use the word "numerically" and not the words "statistically significant." That's called a weasel, intended to imply that the differences were meaningful when they were not. In any legitimate quantitative study, findings need to show statistical significance, not a numerical difference. The statement should read "In Type 1 diabetics, Afrezza performed at parity to Novolog.
Adam:"The study met its primary endpoint -- barely -- only because MannKind set a low bar with respect to the statistical non-inferiority endpoint."
Congratulations Adam, you presented a fact. The study did meet it's primary endpoint. End of story. However, correct me if I'm wrong, didn't Mannkind develop the study and endpoints in conjunction with the FDA? If it's good enough for the FDA to be statistically non-inferior (or parity), then it should be good enough for us laymen, yes?
Adam: "Results from the study in Type 2 diabetics were more favorable for Afrezza but still, the product under-performed relative to MannKind's expectations."
Excellent, another fact: Results from the study in Type 2's were more favorable for Afrezza. Period. How it performed relative to Mannkind's expectations, assuming you even have evidence of what those expectations were, is a non-starter. The bottom line is the results overall were more favorable than Novolog.
Adam: "Afrezza also caused more weight gain in Type 2s."
You're correct. However, you left this out: Afrezza caused less weight gain vs. rapid-acting analogs (according to Mannkind). How this information impacts approval remains to be seen. I look forward to the FDA's opinion.
Adam: "We still don't know, exactly, how the current "Dreamboat" inhaler performed relative to the older Medtone inhaler."
You're right, we don't. But that was not the purpose of the study. The purpose was to ensure that Afrezza was efficacious with respect to the new, improved Dreamboat inhaler. The study met it's endpoints - end of story.
Adam: "We know the inhaled insulin causes a persistent cough. MannKind claims the cough is benign, but what will FDA say?"
Correct me if I'm wrong, but isn't the word PERSISTENT your word? This is contrary to what Mannkind presented as a finding: "The most common respiratory side effect experienced with Afrezza in trials was a mild, transient, non-productive cough. Discontinuation due to cough was uncommon." Whom should I believe, those involved with the trials and having access to the full data, or you? I guess we'll find out. I definitely want to hear what the FDA will say.
In summary, based on only the FACTs that you presented (and not all of the facts presented by Mannkind), here is what we know:
1. Afrezza met its primary endpoints in the trial.
- Afrezza performed at parity to Novolog in Type 1's.
- Afrezza performance vs. Novolog was more favorable in Type 2's.
2. Afrezza caused a cough, but there is a dispute between Adam and Mannkind as to how that cough is characterized.
- Mannkind characterizes it as benign.
- Adam, who was not at the trials and admittedly not privy to all of the data, characterizes it as persistent.
4. Afrezza caused some weight gain in Type 2's. (No information provided by Adam re Type 1's but Mannkind says that Type 1's experienced less weight gain vs. rapid-acting analogs.)
5. Adam does not have enough information to assess product safety.
In addition to those conclusions, here are some additional facts, according to Mannkind, that readers might find relevant. (Adam, if you have data to contradict these findings please feel free to provide.)
1. Use of Afrezza resulted in a reduced risk of hypoglycemia vs. rapid-acting analogs.
2. Afrezza demonstrated reductions in HbA1c.
3. Afrezza delivers insulin without the use of injections.
Thank you for allowing me the opportunity to respond to your article. I look forward to any additional information you can provide, including factual evidence of mis-characterizations on my part. I am open-minded and willing to be proven wrong. After all, I have real money invested in Mannkind.
Biotech Stock Mailbag Extra: MannKind's Afrezza Panel Setup - Adam's Biotech Beat - TheStreet
Kathleen • 12 hours ago
So with all those important things you are involved in (I checked "your" bio online) you found time to post on a blog in the middle of the day. Why, you even "know" that Adam has never shorted a stock. Too funny.
Kathleen • 13 hours ago
I googled him too. Perhaps someone should call Dr. Karpf to see if was actually he who posted on this blog. I have my doubts.
Kathleen • 13 hours ago
As a follow-up to my earlier post outlining my concerns with Adam's analysis, I would like to say that I expect more out of The Street than articles such as this. As an investor, I count on The Street objective, fact-based analysis with conclusions drawn from an assessment of those facts. I have no problem with contrarian opinion, so long as there are facts to back it up. And as a special note to Adam, I hope that you stick to the facts and dispense with the childish commentary as evidenced by your tweets from the JPM Conference (you know what I mean), when you blog from the FDA panel. Your readers deserve nothing less.
Kathleen • 14 hours ago
Correction - numbers 4 & 5 should be 3 & 4. Missed that in my editing.
Kathleen • 14 hours ago
Adam, as a former market strategy consultant with Fortune 500 companies, former corporate senior executive and Harvard MBA I find your case against Mannkind less than compelling and at times totally without merit. Normally, cases are made using concrete facts - and in the case of quantitative studies, using significantly significant findings, not conjecture and spin (or as they call it in the ad business, weaseling). While there are some facts in your analysis, your use of conjecture and spin intended to appear as facts is especially troubling. Let me address your case point by point.
Adam: "Maybe MannKind totally mis-read the situation and FDA always intended to convene a panel for Afrezza."
OK - what if Mannkind misread the situation? So what? Does that count against Afrezza with respect to FDA approval? Your use of the word "maybe" suggests that you really don't know the facts which, in this case, if they existed, are irrelevant.
Adam: "Or, maybe some time between last fall and January, MannKind received feedback from the FDA suggesting the agency had serious problems with the new Afrezza phase III data."
Seriously, is this what you consider fact? Again, your use the word "maybe" demonstrates pure conjecture on your part. In fact, it seems like a blatant attempt to foster serious misgivings about Afrezza's phase III data. Where is your proof? Feel free to provide it. There are many who have serious money invested in Afrezza who deserve to know.
Adam: "In Type 1 diabetics, Afrezza was numerically worse than Novo Nordisk's (NVO) Novolog."
Interesting that you had to use the word "numerically" and not the words "statistically significant." That's called a weasel, intended to imply that the differences were meaningful when they were not. In any legitimate quantitative study, findings need to show statistical significance, not a numerical difference. The statement should read "In Type 1 diabetics, Afrezza performed at parity to Novolog.
Adam:"The study met its primary endpoint -- barely -- only because MannKind set a low bar with respect to the statistical non-inferiority endpoint."
Congratulations Adam, you presented a fact. The study did meet it's primary endpoint. End of story. However, correct me if I'm wrong, didn't Mannkind develop the study and endpoints in conjunction with the FDA? If it's good enough for the FDA to be statistically non-inferior (or parity), then it should be good enough for us laymen, yes?
Adam: "Results from the study in Type 2 diabetics were more favorable for Afrezza but still, the product under-performed relative to MannKind's expectations."
Excellent, another fact: Results from the study in Type 2's were more favorable for Afrezza. Period. How it performed relative to Mannkind's expectations, assuming you even have evidence of what those expectations were, is a non-starter. The bottom line is the results overall were more favorable than Novolog.
Adam: "Afrezza also caused more weight gain in Type 2s."
You're correct. However, you left this out: Afrezza caused less weight gain vs. rapid-acting analogs (according to Mannkind). How this information impacts approval remains to be seen. I look forward to the FDA's opinion.
Adam: "We still don't know, exactly, how the current "Dreamboat" inhaler performed relative to the older Medtone inhaler."
You're right, we don't. But that was not the purpose of the study. The purpose was to ensure that Afrezza was efficacious with respect to the new, improved Dreamboat inhaler. The study met it's endpoints - end of story.
Adam: "We know the inhaled insulin causes a persistent cough. MannKind claims the cough is benign, but what will FDA say?"
Correct me if I'm wrong, but isn't the word PERSISTENT your word? This is contrary to what Mannkind presented as a finding: "The most common respiratory side effect experienced with Afrezza in trials was a mild, transient, non-productive cough. Discontinuation due to cough was uncommon." Whom should I believe, those involved with the trials and having access to the full data, or you? I guess we'll find out. I definitely want to hear what the FDA will say.
In summary, based on only the FACTs that you presented (and not all of the facts presented by Mannkind), here is what we know:
1. Afrezza met its primary endpoints in the trial.
- Afrezza performed at parity to Novolog in Type 1's.
- Afrezza performance vs. Novolog was more favorable in Type 2's.
2. Afrezza caused a cough, but there is a dispute between Adam and Mannkind as to how that cough is characterized.
- Mannkind characterizes it as benign.
- Adam, who was not at the trials and admittedly not privy to all of the data, characterizes it as persistent.
4. Afrezza caused some weight gain in Type 2's. (No information provided by Adam re Type 1's but Mannkind says that Type 1's experienced less weight gain vs. rapid-acting analogs.)
5. Adam does not have enough information to assess product safety.
In addition to those conclusions, here are some additional facts, according to Mannkind, that readers might find relevant. (Adam, if you have data to contradict these findings please feel free to provide.)
1. Use of Afrezza resulted in a reduced risk of hypoglycemia vs. rapid-acting analogs.
2. Afrezza demonstrated reductions in HbA1c.
3. Afrezza delivers insulin without the use of injections.
Thank you for allowing me the opportunity to respond to your article. I look forward to any additional information you can provide, including factual evidence of mis-characterizations on my part. I am open-minded and willing to be proven wrong. After all, I have real money invested in Mannkind.
