Very good article from Jeff Eiseman

[babaoriley]

seekingalpha.com/article/2106003-fear-greed-and-prudent-risks-a-clarion-call-to-the-keepers-of-the-mannkind-flame

This encapsulates the current state of affairs well.

[babaoriley]

Seems that those longs wanting to avoid risk (including Deerfield), those remaining shorts that are still actively shorting (can't be too many of those at this point), and those who might be interested in buying, but are waiting for a better price, and therefore not helping the price, are to blame for the dismal performance of the stock this week, and, more specifically, today.

Tough to say if we drop further tomorrow, but if we do, we might get a bounce Friday; on the other hand if we bounce tomorrow, we will likely give it back and then some on Friday, as the scary articles hit the internet. Then comes Monday, last chance to get onboard before what has been called a binary event. An up day? I think so, especially if Friday is down.

Everything hits the fan on Tuesday all during the AdCom, but regardless of who blogs what, it will be the vote that controls the sentiment. Do they recommend and if they recommend, how strongly do they recommend, for Type 1, for Type 2, and what label implications or discussions will occur?

A strong recommendation for approval for both Type 1 and Type 2, we will see a decent rally on Wednesday open. How long will it last? Tough to say, but unlike this week, where long time longs are looking to sell some and reduce risk, next week, with the backing of AdCom, should we get that, then the longs will remain long, for the most part. Plus, more than a few more may want to join on the long side, so a completely different dynamic than this week. If we close at $5.30 on Monday, I can see an open of $7 on Wednesday, with a peak of about $8, but almost certainly we will not close on or near the highs of the day (if we do, that would be a wonderful sign of strength).

I know many here expect more, and, of course, I hope you're right. But I just don't see higher without a big time partner.

[biotec]

Im calling Friday as a somewhat binary/importing day, People want a look at whats going to take place at the Adcom , I hope that info is released early Friday morning

[liane]

Another one from Jeff Eiseman:

seekingalpha.com/article/2115243-what-the-fda-document-says-about-afrezza-implications-for-fda-approval

[4allthemarbles]

We had an interesting discussion on his latest article (clarion, above) on another thread -(Nice SA article?). Jeff's responses to the article comments were pretty good, better then the article, IMHO.

[otherottawaguy]

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

[thekindaguyiyam]

Mar 28, 2014 14:25:43 GMT -5 liane said:

Another one from Jeff Eiseman:

seekingalpha.com/article/2115243-what-the-fda-document-says-about-afrezza-implications-for-fda-approval

thanks Liane.

It took reading this article to get where he was coming from in the first piece I had read by Jeff Eiseman.
Here is the entire article.  My holdings remain significant as they are for all of us.  Best to you.

"What The FDA Document Says About Afrezza: Implications For FDA Approval
Mar. 28, 2014 3:19 PM ET | 58 comments | About: MNKD
Disclosure: I am long MNKD. (More...)
Summary

The 249-page FDA document released this morning has been distorted by early press releases.
If Afrezza is not approved, the reason won’t be because of findings related to safety.
The FDA may not approve Afrezza for Type 1 at this time, but I believe that it will do so eventually.
I predict that the FDA will approve Afrezza for Type 2 with a favorable label.
The FDA AdCom panel will convene on Tuesday to review Afrezza, the inhaled insulin developed by MannKind (MNKD). The 249-page document released this morning for Tuesday's briefing panel has been distorted by early press releases. My explanations are brief because I want to get this published while there is still trading time.

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There is generally good news for MannKind, but there are also issues that might prevent Afrezza from being approved for Type 1 diabetes, which represents less that 10 percent of the market. The key highlights are:

1. There are no cardiovascular or cancer-related concerns flagged.

2. The information about weight gain in the Type 2 trials was not seen as important.

3. A pulmonary committee did not recommend for or against pooling the MedTone FEV data with the Gen2 FEV data. It said that this was an issue for the AdCom to discuss. Given that there was no apparent clinical significance for at least most of those that had a decreased FEV result, that any label would likely advise testing after the first six months and then annually, and that if there was a significant drop in FEV data revealed by such testing, patients could always stop taking Afrezza, I do not expect that this will prevent approval.

4. A similar statement can be made about coughing. Coughing was one of the primary reasons some subjects dropped out, but obviously those who are sufficiently bothered by coughing (for example, when it doesn't go away after a couple of weeks or is more severe than a mild annoyance) can stop. Coughing is not a basis for recommending against approval.

5. There was some concern about the dropout rate for subjects taking Afrezza, especially in the Type 1 study. As long as the main endpoint is considered to be A1c, then panel members may not consider Afrezza to be non-inferior, given that in the most recent study it was barely non-inferior (without taking into account the dropouts which might have reversed the conclusion). However, eventually the FDA will recognize the importance of taking into account the size of blood sugar swings or even just the size of blood sugar surges and recognize that Afrezza is actually superior on the metrics that correlate with long-term health and survivability.

6. There was also a concern that there is not a linear relationship between the dose that Afrezza patients take and the amount that blood sugar levels are reduced. This is not a reason to recommend against approval, but it means that MannKind has to figure out how to give better advice for patients who require a lot of prandial insulin. There may be an upper limit. One solution for those requiring high amounts is, for Type 2, to add another oral medication or to add or increase the amount of basal insulin. The latter approach seem to have worked in the trials for those with Type 1 diabetes, although the FDA commenter drew a different conclusion. It is too early to tell whether there is an upper limit for Afrezza doses, although if there is, it is a limit based on efficacy rather than safety.

7. There is not the same concern about the results for those who have Type 2 diabetes. While at least one reviewer commented that the size of the advantage over the placebo was modest in terms of reducing A1c, it nevertheless met the endpoints. Again, doctors and insurance companies will care more about slowing down or preventing long-term complications and that is where the size of blood sugar surges and wings matter, and why Afrezza will do well after approval.

8. There was discussion of possible labeling if approved. It is likely to discourage, and perhaps even recommend against, use for smokers or those with underlying lung disease. It may also do so, although with less vigor, for people with underlying liver problems.

My bottom line is that I believe the chances that it will be approved for Type 2 diabetes is excellent, and although I recognize that the chances that it will not at this time be approved for Type 1 diabetes, it may in fact be with a label describing some of the concerns related to the Type 1 results.

As soon as I submit this article, I shall add to my position."