Thank You For Riding The MannKind Catalyst Train

[savzak]

New on Seeking Alpha:

seekingalpha.com/article/2050643-thank-you-for-riding-the-mannkind-catalyst-train-please-exit-safely-at-the-next-available-station?isDirectRoadblock=false&source=email_rt_article_readmore&uprof=45

[spiro]

Well written article, but mostly nonsense. I wonder how much the hedge funds paid him to write this crap. So, he feels bad for the longs who haven't sold yet.  I feel bad for the shorts who didn't cover when MNKD was below $5. At least the longs are making money. To compare Afrezza to all of those drugs with multiple and serious issues is totally ridiculous. Let's see, did I tell you Afrezza causes a slight cough when first used, but it might save your life by preventing severe hypoglycemic events. Oh by the way, you type 1's will still have to inject one time, so why use Afrezza? you only need 3 more injections a day. I also guess he is not to concerned about the type 2's, most of whom are using the Alzheimer's linked Metformin. 

[spiro]

George Rho , Contributor
Comments (355)

Hello Michael,

I'm not sure what to make of your article. Like your long email to me on January 26th, definitely interesting but consisting mostly of mumbo jumbo.

In the interest of full disclosure, I think you should have told your readers what you told me in the email. To quote: "What I do, is the subject of reflexive ridicule - I use tarot card readings to predict outcomes of companies."

The article uses a lot of quotations from various sources to make it sound reasonable, and there are a few things with which I do agree, but there's so little substance. It comes across, to me, at least, that the cards helped you reach a conclusion, then you tried to make it sound more respectable by parsing words and using facts very selectively.

On a final note, as an analyst of some 25 years now, I found the statement --"There are already some experts who believe that approval of Afrezza by the PDUFA date is extremely unlikely."--rather comical, given the one expert cited is a brokerage house.

Anyway, as with your long emails, I enjoyed the article. Stay in touch.

[savzak]

It's a "kinder, gentler" hit piece. The author apparently fancies himself a seer. His notion is that he understands the subtleties of the human psyche in a special way and he combines this amazing insight with his "parsing of managements words" (his words, not mine) so as to come to the conclusion that:

1. Management has not properly finessed the subconscious of the FDA and the Committee members and
2. Management's language demonstrates that they are wishing reality away or whistling past the graveyard and
3. Accordingly, the reader should sell before ADCOM if he is smart.

His wants the reader to believe that his concern lies with human nature, not with Afrezza, which he believes is a wonderful product. Don't worry though, there isn't an overt conspiracy at the FDA...just human nature at play.

He doesn't explain why he is making his thoughts known now. Everything he says in this piece could have been said months ago. The fact that Afrezza is competition for other BP's that have longer term relationships with the FDA has always been the case. It's no more true now than it was a month ago or two months ago.

[ashiwi]

He says he is not short, but did not say that he is getting paid by a short hedge fund. Who spends hours writing this stuff which takes some serious twisting of facts without some sort of compensation or an ulterior motive.

[spiro]

George Rho  second response.



George Rho , Contributor
Comments (356)

The following is another excerpt from the email:

"The investor card was the 10 of swords which isn't fortuitous in this case. Whether by traditional interpretation or modern, it indicates affliction, desolation, grievances, faith shattered, enemies and grave misfortune. Nothing could be clearer.

Now, why have I shared all this with you. To entertain you. Nothing more.

Will I be mistaken? It sure looks like I will. If I were to look at this adcomm and PDUFA, I'd arrive at the same conclusions you have. But that's only part of what I do."

My apologies Michael... I hope you'll do all the readers of this article who've taken the time to comment the courtesy of a response. For some odd reason, none of your cohorts, including the EnhydriPECorp that you noted, ever bother to defend their respective articles.

[Chris]

My favorite comment:

"This is an outrageous twisting of facts by the author to make yet one more negative SA article against MNKD. YOU CAN'T PICK AND CHOSE WHICH ONES YOU WANT TO POST TO MAKE YOUR POINT!
In 5 years FDA Advisory Committees have an approval rate of 71%. Your bias is so egregious you should be banned from writing SA articles.

5-Year Meeting Quick Facts:

169 Total Meetings
121 Products Approved by the FDA
Average Meeting per Year = 33
103 were related to NDAs
31 to BLAs
26 to sNDAs and 9 to sBLAs

tmsnrt.rs/1eqxKim"

[babaoriley]

"I use tarot card readings to predict outcomes of companies." Well, hold on here, just what do others use?? I mean, I have also "thrown bones," but tarot cards are good.

[spiro]

I prefer the Ouija board.  It keeps coming up buy MNKD every time. 

[babaoriley]

Well, okay, I didn't mean to downplay the Oiija board, just forgot to mention it! Sure, that's a good method, too. I'm confident we all use similar methods, how else is one to decipher the world of high-finance, especially when it merges with biotechnology.

[alcc]

Where do they find all these morons?

[mrhaigs]

The comments are pretty funny on this one. I like the ones from other users regarding George Rhos response. Hilarious! Almost as funny as that awful ormp article, that was a clear bash at mnkd, written by sharon di stefano who is an absolute idiot. If you haven't read it yet, and wand a good laugh, check it out on seeking alpha....

After writing that I see she may have taken it down. If you can find it I advise reading it just for the comments. There's well over 100 of them and are hilarious.

[mrhaigs]

The author is starting to reply to the comments. He is literally insane or the guy from V for Vendetta. I'm laughing out loud at a hotel bar reading these.

[Chris]

Feb 27, 2014 20:36:24 GMT -5 mrhaigs said:

The author is starting to reply to the comments. He is literally insane or the     guy from V for Vendetta. I'm laughing out loud at a hotel bar reading these.

I think he's been puffing something really ~~ gooodd ~~ (hint:  It's not the Dreamboat inhaler).

[Chris]

Here I will refute everything listed on the bearish signal side of the above posted slide:

1) MNKD disclosed all primary endpoints were met and any data withheld is for the purpose of submitting new data to journals and presentations at conferences. Deerfield tranche was also met upon successful completion of Phase III.

2) At this point in the game, any partner would more than likely hold back until FDA Approval or at the minimum wait for the Adcom meeting before proceeding with a partnership. Greenfield has been hired and on numerous occasions have been thanked by MGMT and the prospective search and list of partners is growing - thus MNKD has not released Greenfield and hired another firm. CEO Alfred has stated there are many regional partnerships offers so at the very least we know MNKD has a contingency plan in the off chance a large BP does not step-in.

3) Not necessarily contradictory reasons on why there is an Adcom request but multiple possibilities as to why one was initiated by the FDA. I would add that MGMT has foreseen and planned for an Adcom and hired a consultant to advise them during the Adcom.

4) Although Type 2's gained more weight, it was a very minute and Afrezza has been shown to be non-inferior.

5) Persistent cough during the adaption stage that typically dissipates over time. No permanent effects on the lungs - reversible. Although some patients coughed, the trial drop-out rate was small -- thus one can assume the coughing was not so relentless as to be unbearable.

6) I love this point because, I thought so too until I did some deep DD and research:

In 2010 Hapoalim Q3 stated,

"Because of the FDA’s bias against approving new products and because no expert panel is scheduled ahead of the December 29 PDUFA date, we continue to expect Afrezza to get a Complete Response Letter. We reiterate our SELL rating and $1 Price Target."

In 2010 Oppenheimer also stated,

"On 10/29, MNKD reported 3Q 2010 EPS of ($0.40) vs. our estimate of ($0.38) and consensus of ($0.39) on higher than expected R&D expenses.



(1) Importantly, we continue to believe MNKD will receive a CRL by its PDUFA.



(2) We also believe that the lack of an FDA Adv. Comm. is not favorable for approval.



(3) Furthermore, we note the new addition to MNKD's manufacturing facility, which has not been inspected, may pose additional risk to approval.



(4) MNKD has also commenced additional pilot program studies in order to facilitate EU approval and expand their label once Afrezza is approved, which we view as unlikely."

afresa.blogspot.com/search/label/Hapoalim
afresa.blogspot.com/search/label/Oppenheimer

7) Bridged data with invitro and invivo testing proving equivalence. Also note this most recent slide presented, showing MNKD to the best of their abilities followed the guidelines outlined by the FDA: 




(thanks hopetoretire for this slide).