Very good article from Jeff Eiseman
Mar 29, 2014 11:21:24 GMT -5
liane, mapotofu10, and 4 more like this
Post by otherottawaguy on Mar 29, 2014 11:21:24 GMT -5
Here is a response in the comments from George Rho. Wonder if we will see an article from him on Monday?
George Rho, contributor
Comments (438)
Quoting an anonymous e-mailer who wasn’t happy that I wasn’t out defending his equity position in MNKD, “what gives?”
The simple answer is fatigue. A more substantive response is the sense that it’s all been said before and probably to no avail.
Both MannKind’s and the FDA’s briefing documents (BD) are long and detailed, taking most of last night to review; not sure it was the best way to spend a Friday night. The FDA’s version certainly graphically details Afrezza’s shortcomings. Indeed, as highlighted in the first draft question, the regulators point out the Afrezza provides “numerically and statistically less Hba1c reduction than a comparator subcutaneous insulin.” Moreover, it’s pointed out that the inhaled insulin didn’t meet the primary efficacy endpoint of not being inferior under the worst-case sensitivity analysis, when dropouts are taken into consideration. MNKD investors were undoubtedly also unnerved by the pages upon pages detailing possible connections between inhaled insulins and lung cancer, skin cancer, heart disease, retinal detachment, pulmonary issues and every other possible health problems under the sun. And, to the delight, I’m sure, of many of MannKind’s detractors, the briefing document also talks about “missing data,” even if not in the same context that they’ve used all these many months. Just for the record, the “missing data” the regulators are referring to is the data that wasn’t collected because some of the participants decided to drop out of the trial.
All that said was there anything new of significance in the 217 page MannKind BD or the 249 page FDA BD? I certainly didn’t read every single word or scrutinize every graph and table in the two documents, but my assessment would have to be no. Afrezza is not the perfect drug, I think we’ve all known that for years. Is it appropriate for use by every diabetic? Obviously not and again, this is no secret. Did the regulators have problems with the drug and certain aspects of the clinical trials? Of course, and that partly explains the reason for the AdCom on Tuesday. The FDA BD doesn’t address the following in any meaningful way, but another consideration for the AdCom panel members are the alternatives to Afrezza. Are the injectable insulins perfect? Is the reduction of Hba1c the end all and be all of treating diabetes? Are diabetics who need insulin likely to begin therapy earlier if they have the option of inhaled insulin or not? Insulin Aspart may result in slightly greater Hba1c reduction than Afrezza, but how important is that when some diabetics postpone treatment, sometimes for years, because of an aversion to injections? A Seeking Alpha article on Thursday reviewed in detail the many shortcomings of subcutaneous insulin. None of this was discussed in the regulators BD, but all of that is clearly of relevance in the final analysis.
Bottom line, Afrezza met the primary endpoints in the trials for both type 1 and type 2 diabetes, as set by the FDA, and none of the details that are spelled out excruciatingly in the BD are sufficient to derail approval, in my opinion. Significantly, too, even the most critical assessments by regulators show very little evidence of concerns about the drug’s safety.
As to MNKD stock’s price action yesterday, where to begin? We’ve talked about fear, fiction, misinformation, and disinformation in previous articles. I think all of this was on display yesterday. Articles emanating from anonymous authors on websites like Seeking Alpha and Motley Fool can affect a stock price, or so we’d like to believe. So, imagine the impact of major news outlets like Bloomberg, Reuters, Fox Business, theflyonthewall, and others, all of which heralded their stories early yesterday morning with titles that were clearly alarming and disconcerting. As if often the case, however, and I’m sure many long-time followers of MannKind will agree, none of the authors of those stories provided any context or perspective. Indeed, the rapidity with which the articles appeared strongly suggests that the writers might have gleaned the draft questions, did a brief google search, and rushed to publish…. report first and ask questions later.
MannKind investors, a group that appears to include many that follow every painful tick of the stock price, clearly didn’t fare well last week. That said, the company lost $156 million in market value yesterday, contrary to the billion-dollar figure some regular commenters on these pages keep on repeating. That’s not all, it’s also worth keeping in mind that the stock market in general, and individual stock prices, in particular, do not always accurately discount news, especially in the short term and factoring in an age when “news” can be so easily distorted.
29 Mar, 09:34 AM
George Rho, contributor
Comments (438)
Quoting an anonymous e-mailer who wasn’t happy that I wasn’t out defending his equity position in MNKD, “what gives?”
The simple answer is fatigue. A more substantive response is the sense that it’s all been said before and probably to no avail.
Both MannKind’s and the FDA’s briefing documents (BD) are long and detailed, taking most of last night to review; not sure it was the best way to spend a Friday night. The FDA’s version certainly graphically details Afrezza’s shortcomings. Indeed, as highlighted in the first draft question, the regulators point out the Afrezza provides “numerically and statistically less Hba1c reduction than a comparator subcutaneous insulin.” Moreover, it’s pointed out that the inhaled insulin didn’t meet the primary efficacy endpoint of not being inferior under the worst-case sensitivity analysis, when dropouts are taken into consideration. MNKD investors were undoubtedly also unnerved by the pages upon pages detailing possible connections between inhaled insulins and lung cancer, skin cancer, heart disease, retinal detachment, pulmonary issues and every other possible health problems under the sun. And, to the delight, I’m sure, of many of MannKind’s detractors, the briefing document also talks about “missing data,” even if not in the same context that they’ve used all these many months. Just for the record, the “missing data” the regulators are referring to is the data that wasn’t collected because some of the participants decided to drop out of the trial.
All that said was there anything new of significance in the 217 page MannKind BD or the 249 page FDA BD? I certainly didn’t read every single word or scrutinize every graph and table in the two documents, but my assessment would have to be no. Afrezza is not the perfect drug, I think we’ve all known that for years. Is it appropriate for use by every diabetic? Obviously not and again, this is no secret. Did the regulators have problems with the drug and certain aspects of the clinical trials? Of course, and that partly explains the reason for the AdCom on Tuesday. The FDA BD doesn’t address the following in any meaningful way, but another consideration for the AdCom panel members are the alternatives to Afrezza. Are the injectable insulins perfect? Is the reduction of Hba1c the end all and be all of treating diabetes? Are diabetics who need insulin likely to begin therapy earlier if they have the option of inhaled insulin or not? Insulin Aspart may result in slightly greater Hba1c reduction than Afrezza, but how important is that when some diabetics postpone treatment, sometimes for years, because of an aversion to injections? A Seeking Alpha article on Thursday reviewed in detail the many shortcomings of subcutaneous insulin. None of this was discussed in the regulators BD, but all of that is clearly of relevance in the final analysis.
Bottom line, Afrezza met the primary endpoints in the trials for both type 1 and type 2 diabetes, as set by the FDA, and none of the details that are spelled out excruciatingly in the BD are sufficient to derail approval, in my opinion. Significantly, too, even the most critical assessments by regulators show very little evidence of concerns about the drug’s safety.
As to MNKD stock’s price action yesterday, where to begin? We’ve talked about fear, fiction, misinformation, and disinformation in previous articles. I think all of this was on display yesterday. Articles emanating from anonymous authors on websites like Seeking Alpha and Motley Fool can affect a stock price, or so we’d like to believe. So, imagine the impact of major news outlets like Bloomberg, Reuters, Fox Business, theflyonthewall, and others, all of which heralded their stories early yesterday morning with titles that were clearly alarming and disconcerting. As if often the case, however, and I’m sure many long-time followers of MannKind will agree, none of the authors of those stories provided any context or perspective. Indeed, the rapidity with which the articles appeared strongly suggests that the writers might have gleaned the draft questions, did a brief google search, and rushed to publish…. report first and ask questions later.
MannKind investors, a group that appears to include many that follow every painful tick of the stock price, clearly didn’t fare well last week. That said, the company lost $156 million in market value yesterday, contrary to the billion-dollar figure some regular commenters on these pages keep on repeating. That’s not all, it’s also worth keeping in mind that the stock market in general, and individual stock prices, in particular, do not always accurately discount news, especially in the short term and factoring in an age when “news” can be so easily distorted.
29 Mar, 09:34 AM