AdCom voting roster

[ehsteinert]

I find it interesting that there are various AdComs scheduled into June, and the voting rosters are already posted. Ours is not, even though it is only weeks away. That concerns me and that all MNKD investors should follow closely.

There is one standing member named Dr. Mads Rasmussen. He has been serving as a non-voting "industry representative," and is the Executive Director, Clinical Development and Research, Diabetes Clinical Development, Medical and Regulatory Affairs...

for Novo Nordisk Inc.

One of Novo Nordisk's most important markets is diabetes treatment. THEY MAKE INSULIN PENS. MannKind is using insulin pen pricing as their model for Afrezza pricing. If Afrezza is approved, insulin pens will be the first products impacted by MannKind's Dreamboat delivery system.

Dr. Rasmussen has about as extreme a conflict of interest with Afrezza as you could possibly construct. Yes, his status has been non-voting as recently as December's committee meeting. But there is a waiver system in place at the FDA to grant voting status to committee members with conflicts. In theory it is very rigid process, but we have seen dark forces at work in the past regarding the Afrezza approval process.

I'm watching this very closely and so should you. It's bad enough that Dr. Rasmussen will be in the same room as the committee meeting. If suddenly he is waivered to voting status you can bet something is going on behind the curtain.

Afrezza represents a huge threat to the existing diabetes products market. $$billions are at stake, and I don't put anything past Big Pharma's/Wall Street's vested interests.

GLTAL

[notamnkdmillionaire]

My theory is that the FDA might be on the verge of approving it prior to the ADCOM. There is nothing to stop them from doing it. All they do is release the info and the approval is published on the FDA website. BINGO. No need for an adcom. I have no idea if that will happen but it really would be a more than pleasant surprise. It would catch everyone off guard, including those who decided to short.

[babaoriley]

"I'm watching this very closely and so should you. It's bad enough that Dr. Rasmussen will be in the same room as the committee meeting. If suddenly he is waivered to voting status you can bet something is going on behind the curtain."

Well, if he became a voting member, there would be nothing "behind the curtain" - it would be blatant, because, the facts as you describe them create a serious conflict of interest.

Afrezza should be approved, easily and without further delay, and for Type 2 as well. Thousands of patients, with no serious side effects. Jumped through plenty of FDA hoops. Faster acting, with fewer middle of the night disasters. A more "socially acceptable" manner in which to administer, and so friendly for those who are needle-averse (99.9% of humans).

Share price? Likely a disconnect with the facts - can't have everything! LOL!

[mannmade]

I agree with you guys and as a former compliance lawyer (broadcast) it would certainly seem to be a major conflict, however disclosure does serve to mitigate it somewhat and the process is much more transparent. I am awaiting judgement since as I recall among other things, I believe Novo is one of the very few (if there are indeed any others) who are hiring diabetes sales and educational staff in any volume. So perhaps this is actually a good thing? Looking for the bright side...

[thekindaguyiyam]

With fortunes at stake it would surprise the hell out of me if there wasn't adversarial comments made in multiples.  The data remains the data and this person's spin will clearly be viewed as Novo's spokesperson defending their product and attacking any challengers.  Just give us the facts and acknowledge the science.  It would be my guess that Mads Rasmussen has already been a part of the conversation with the FDA.  

I have been wanting to hear more information about who the adversaries are.  I could use the edjamaction; if anyone care to talk about this.

Good Post.  Thanks

www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM309757.pdf

[StevieRay]

Mar 9, 2014 14:01:51 GMT -5 ehsteinert said:

I find it interesting that there are various AdComs scheduled into June, and the voting rosters are already posted. Ours is not, even though it is only weeks away. That concerns me and that all MNKD investors should follow closely.

There is one standing member named Dr. Mads Rasmussen. He has been serving as a non-voting "industry representative," and is the Executive Director, Clinical Development and Research, Diabetes Clinical Development, Medical and Regulatory Affairs...

for Novo Nordisk Inc.

One of Novo Nordisk's most important markets is diabetes treatment. THEY MAKE INSULIN PENS. MannKind is using insulin pen pricing as their model for Afrezza pricing. If Afrezza is approved, insulin pens will be the first products impacted by MannKind's Dreamboat delivery system.

Dr. Rasmussen has about as extreme a conflict of interest with Afrezza as you could possibly construct. Yes, his status has been non-voting as recently as December's committee meeting. But there is a waiver system in place at the FDA to grant voting status to committee members with conflicts. In theory it is very rigid process, but we have seen dark forces at work in the past regarding the Afrezza approval process.

I'm watching this very closely and so should you. It's bad enough that Dr. Rasmussen will be in the same room as the committee meeting. If suddenly he is waivered to voting status you can bet something is going on behind the curtain.

Afrezza represents a huge threat to the existing diabetes products market. $$billions are at stake, and I don't put anything past Big Pharma's/Wall Street's vested interests.

GLTAL

Oh God!  Not another Boogeyman!  Somebody get Spiro and his Voodoo spell ready for another intervention!  And hurry!  I'm getting scared again!  I told you this would happen!  I swear to God, if I survive through this investment I promise Lord, I'll give up BioTechs altogether.  I'll go to church every other Sunday and twice on Easter!  Just let me survive through FDA approval and I promise I'll be good the rest of my life!

A little more prayer and a touch of Voodoo ought to do the trick!

[spiro]

You guys are too much!  I believe the Yoda on this one. Fear leads to Anger, anger leads to hate and hate leads to selling. OK, maybe he said suffering. Up until today, I thought Dr. Rasmussen ran a polling firm. What is he doing on our AdCom? Personally, I don't care who this guy Rasmussen works for, the AdCom will vote in favor of approving Afrezza, by a huge margin.  Furthermore, i have come to the conclusion that big pharma is not interested in partnering with MNKD. I now believe that they prefer an outright buyout of the entire company. This will happen very soon after approval. depending on the label, I am predicting a buyout price of somewhere between $50  and $75 per share. These big drug companies know that if they partner first and then Afrezza becomes the expected blockbuster in 2 or 3 years, a buyout will cost them 3 or 4 times more because of the added potential of the Technosphere pipeline. Also, GLP 1 with Technosphere delivery could prove quite valuable in the future. Al Mann will still have skin in the diabetes game, because one of his private companies is working on another potential monster in the basal insulin patch. MNKD is so undervalued at $5.71 it is ludicrous. It's time the longs start manipulating the share price, the shorts have had there way for too long. I am officially fired up now and will be buying more calls on Monday and Tuesday. 

Spiro

[ehsteinert]

I would love to see a buyout. But why do you believe Al hired Greenhill to find a partner? Would you mind sharing your calculations that get you to a buyout in the $50-$75 price range? There are 400+million shares outstanding.

[spiro]

Yes, I know $50 may  seem a little conservative, considering the monstrous size of the diabetes worldwide market, not to mention the value of Technosphere particular in the pain market. When you consider that if everything goes right, MNKD could have over $10 billion in worldwide sales within 6 or 7 years,  I guess $50  a share would seem to be quite a bargain to a big pharma company getting ready to lose patent protection on a $7 billion a year drug. Or maybe they would like to spend $5 billion or so developing a new drug from scratch. OK, but I'm not greedy, I will take $40, but that would make me a little disappointed, but happy. 

[StevieRay]

Mar 9, 2014 21:12:10 GMT -5 spiro said:

Yes, I know $50 may  seem a little conservative, considering the monstrous size of the diabetes worldwide market, not to mention the value of Technosphere particular in the pain market. When you consider that if everything goes right, MNKD could have over $10 billion in worldwide sales within 6 or 7 years,  I guess $50  a share would seem to be quite a bargain to a big pharma company getting ready to lose patent protection on a $7 billion a year drug. Or maybe they would like to spend $5 billion or so developing a new drug from scratch. OK, but I'm not greedy, I will take $40, but that would make me a little disappointed, but happy. 

I prefer Marcelo Zinn's Baseline Valuation of MannKind.  It's more balanced and middle of the road at $85 but that's just the sort of guy I am when I'm not hiding under my bed from the Boogeyman!

"Baseline Valuation

Our Baseline Discounted Cash Flow (“DCF”) Model estimates AFREZZA sales of $14B in 2019 (25% Market Share), 15% growth for 7 years, and 7% terminal growth for 7 years. We then discount the result back at 10%/annum to 2014.

We understand that at first blush, most would deem 25% market share for an “unproven” drug within 5 years aggressive. However, we believe the convenience and efficacy benefits highlighted in detail above will drive demand from physicians and improve both the marketing and acceptance, allowing f or major penetration. AFREZZA will thus become the de facto preferred choice for diabetics.

With the above scenario, we come to a value of approximately $85/share today. We consider this our Baseline case and place a 50% weighting."

www.beyondproxy.com/mannkind-corporation/

[ashiwi]

If you go to Greenhill's web site they probably do more mergers and aquasitions than partnering. I thing Spiro is on to something. I just hope his price prediction is better than his kayaking

[ashiwi]

Does anyone know how many voters the Ad Comm will have?

[alcc]

An outright buyout is not likely, especially given the mkt failure of Exubera. Better for both BP and MNKD to have a partnership agreement with a buyout option (with expiration). Less risk for the BP buyer. Higher valuation for MNKD.

[Chris]

Mar 9, 2014 21:46:57 GMT -5 ashiwi said:

Does anyone know how many voters the Ad Comm will have?

Here is a list of the people involved with the Ad Comm.

Chairperson

Vacant

Designated Federal Officer

Karen Abraham-Burrell, Pharm.D.
Division of Advisory Committee and Consultant Management
Office of Executive Programs
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002
Phone: [phone]
Fax: [phone]
E-mail: [e-mail]

Vera A. Bittner, M.D., M.S.P.H.

Expertise: Cardiovascular Disease
Term: 04/25/2011 – 06/30/2014
Professor of Medicine
Section Head, Preventive Cardiology
University of Alabama at Birmingham
701 19th Street South, LHRB 310
Birmingham, Alabama 35294

Erica H. Brittain, Ph.D.

Expertise: Biostatistics
Term: 05/31/2011 – 06/30/2014
Mathematical Statistician
Biostatistics Research Branch
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)
6700A Rockledge Drive (Room 5132) Bethesda, Maryland 20817

David W. Cooke, M.D.

Expertise: Pediatric Endocrinology
Term: 1/11/2013 - 6/30/2016
Associate Professor of Pediatrics
Clinical Director, Division of Pediatric Endocrinology
Director, Pediatric Endocrine Fellowship Training Program
Johns Hopkins University School of Medicine
200 North Wolfe Street, Room 3120 Baltimore, Maryland 21287

Edward W. Gregg, Ph.D.

Expertise: Epidemiology in Diabetes
Term: 04/25/2011 – 06/30/2014
Chief, Epidemiology and Statistics Branch
Division of Diabetes Translation
Centers for Disease Control and Prevention
2877 Brandywine Rd
Williams Building, Room 1505
Atlanta, Georgia 30341

*Diana Hallare, MPH
* Consumer Representative


Expertise: Consumer Representative
Term: 08/22/2013 - 06/30/2017
Visalia, California 93277
Ed J. Hendricks, M.D.
Expertise: Obesity
Term: 05/23/2012 – 06/30/2015
Medical Director
Center for Weight Management
2510 Douglas Blvd, Suite 200
Roseville, California 95661

William R. Hiatt, M.D., FACP

Term: 1/11/2013 - 6/30/2016
Expertise: Cardiology
Professor of Medicine
Division of Cardiology
University of Colorado School of Medicine
President, Colorado Prevention Center (CPC) Clinical Research
13199 E. Montview Boulevard, Suite 200
Aurora, Colorado 80045

**Mads F. Rasmussen, M.D., Ph.D.
** Industry Representative (non-voting)

Expertise: Pharmaceutical Medicine, Endocrinology, Diabetes and Obesity
Term: 04/04/2012 – 10/31/2015
Project Vice President
GLP-1 and Obesity – Global Development
Novo Nordisk A/S.
Novo Allé 1
2880 Bagsvaerd
Denmark

Ellen W. Seely, M.D.

Expertise: Endocrinology, Metabolism, Diabetes
Term: 04/25/2011 – 06/30/2014
Professor of Medicine
Harvard Medical School
Division of Endocrinology, Diabetes and Hypertension
Brigham and Women’s Hospital
221 Longwood Avenue
Boston, Massachusetts 02115

Robert J. Smith, M.D.

Expertise: Endocrinology, Metabolism
Term: 05/23/2012 – 06/30/2015
Professor of Medicine (Endocrinology)
Alpert Medical School of Brown University
Ocean State Research Institute
Providence Veterans Administration Medical Center
830 Chalkstone Avenue
Providence, Rhode Island 02908

Charles A. Stanley, M.D.

Expertise: Pediatric Endocrinology
Term: 1/11/2013- 6/30/2016
Professor of Pediatrics
Perelman School of Medicine University of Pennsylvania
Division of Endocrinology & Diabetes
Children’s Hospital of Philadelphia
Abramson Research Center, Room 802d
34th Street & Civic Center Boulevard
Philadelphia, Pennsylvania 19104

[babaoriley]

Harvard, Brown, Johns Hopkins! Al may be too down to earth for them.

Gosh, I hope we get bought out; I think I may settle for Spiro's conservative $40/share - LOL! I'll just make him mad if I say what I'd settle for, even after approval for Type 1 and 2.

If it is a buyout, my guess is I'll be one of the very few here who will like the price, I guess I never aim high enough!

Also, regarding the stock price the next couple of weeks, there will be a lot of people buying calls instead of purchasing shares, and also will be people selling their shares and replacing them with calls, especially if they think the price will really pop on favorable AdCom and/or approval.