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Looked at it a couple of months back.

 

Basically I like the concept but due to the CRL a couple of months back.  They would have to have some major dilution or some other kind of funding in order to complete another phase 3 trial.

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Looked at it a couple of months back.

 

Basically I like the concept but due to the CRL a couple of months back.  They would have to have some major dilution or some other kind of funding in order to complete another phase 3 trial.

 

I got interested about a month or two back when the CRL came back without any major safety or efficacy issues, yet the share price fell precipitously. Seemed the only issue raised (at that time) was the changing of the delivery method, which appears to be much better.

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  • 3 weeks later...
  • 1 month later...

Oh goodness!  I thought you might be talking about the professional wrestler!!!  On that note, sadly Randy "Macho man" Savage died the other day...  RIP Randy...

 

No, not the wrestler. Al Mann is actually quite the interesting fellow, having great success in several industries (while the jury is still out on his latest venture, MNKD). If you care to see his background in his companies, including the current one, you can see this speech he gave at Yale.

 

http://streaming.yale.edu/cmi2/orator/OCR/20100916/OCR20100916.html

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  • 7 months later...

If anyone is still thinking about Mannkind the following article is interesting.  Seems there was a shadow hand behind the drug approval.

 

 

http://www.gurufocus.com/news/159641/mannkinds-afrezza-was-to-be-approved-what-happened-next-

 

Even better (in a scarcastic tone)  this is the same guy that has tried similar methods for a couple of companies I hold/held.

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  • 2 months later...

I've been following this one for a while - FWIW here’s a random (but not exhaustive) list of some pros + cons (I’ll let you guess which are pros and which are cons):

• Al Mann has quite a track record and has a huge amount invested.

• The product was pretty much approved at one point as per the FDA insider trading case: http://afresa.blogspot.com/2012/03/liang-insider-trading-documents.html

• I’m pretty sure I’m suffering from a severe case of “endowment bias” (and every other bias out there) but it does seem to me that at this stage there’s very little risk with the approval.

o Admittedly, they have to conduct yet another trial, but they’ve proven they can run trials in the past so I’ll be very disappointed if they slip up here.

• Al Mann had a very similar experience with the insulin pump he invented and that went on to appreciate by an obscene amount - no anchoring biases here on my part of course – but boy, if lightning were to strike twice!

• One big question is market acceptance – you’d think this would be a no brainer – no injections, works better than existing treatments… but there’s probably a lot of treatment inertia from doctors that will take some (significant?) effort to overcome – on the other hand patients should come clamoring for it, assuming they aren’t concerned about any possible impact on their lungs (studies have shown no associated risk) – but people are more scared of flying than driving, so what do I know…

• Al Mann could try to take it private, but he does seem to have a history of acting with integrity plus, as MNKD is looking for potential marketing partners I am pretty sure there are some very convincing internal projections that value the company at a meaningful premium to the current price – so those would be difficult to hide if he did try to pull a fast one.

• There do seem to have been some misjudgments on the part of management / Al Mann, for example switching the delivery device at very a late stage - the reason the FDA gave for wanting the new trials

o But there’s a lot more to this than appears at first glance, which I’m not going to try to get into right now.

• And Al Mann does seem to over-promise, which is a bit worrying, however as I noted, he has a tremendous track record and I think part of it is that he must be incredibly frustrated with the whole process at this stage – he’s spent years working on this, invested hundreds of millions of his own money, has conducted trial after trial proving the product works, is safe and is better (significantly it would seem) than existing treatments and he’s still pumping money into it and diabetes patients still can’t get to benefit from the product.

o And all this at an age way past when most people have any desire or ability to work.

• There’s a pretty good (a bit dated mind you) overview here: http://seekingalpha.com/article/80475-mannkind-overlooked-biotech-with-excellent-prospects-part-i

• Francis Chou had a small position, but sold out so I’m assuming I know more about this than he does – seems to me that’s a bit like taking the other side of a bet against Buffett!

• Oh yeah, and they are going to run out of money (again) by around the end of the year.

• And the company is named after the founder…

• MNKD Full Transcript 1-12-12 JPMorgan Healthcare Conference

o http://agoracom.com/ir/Mannkind/forums/discussion/topics/524814-mgmt-statements/?message_id=1661573#message_1661573

o If you’ll read this closely you’ll see Al Mann says the share price will “pop” once financing is in place – sounded wonderful except the price tanked!

o And for some reason (couldn’t be related could it?) the webcast of this on Mannkind’s site never worked.

 

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I bought a few shares a couple of months back.  Talked to a few people that take shots and they were amazed that there was the possibility of not having to have shots anymore (Viewing this as people will go to the doctor asking for the drug once it's out in public.). My dad would have jumped at this b/c the needles were always a pain and hated them with a passion.

 

Main reason for buying is a bet on Al Mann and also the insider trading case.  If it was approved then, despite going through the paces, it should have the same result.

 

Francis Chou does have a position in Mannkind in his Asia fund.  Also the bonds he is holding I view as a position in the stock since they will probably be converted to shares next year.

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"Francis Chou does have a position in Mannkind in his Asia fund."

 

Strange, where do you see that - this link / pdf (http://www.choufunds.com/pdf/Asiaport1112.pdf) supposedly shows all holdings in the Asia fund as of YE 2011, no Mannkind (copied below) - has he established a new position since then?

 

CHOU ASIA FUND

AS OF DECEMBER 31, 2011

Total Holdings

(excluding cash equivalents)

Chunghwa Telecom Company Ltd. ADR 9.2%

Able Chintai Holdings 8.4%

PRONEXUS Inc. 6.9%

Sankyo Company Ltd. 6.4%

BYD Company Ltd., Class H 6.3%

SK Telecom Company Ltd. ADR 4.9%

Pyne Gould Corporation Ltd. 4.1%

UTStarcom Holdings Corporation  3.6%

Qiao Xing Mobile Communication Co.  3.3%

AbitibiBowater Inc.  2.8%

Delta Electronics (Thailand) Public Company Ltd. 2.6%

Glacier Media Inc 2.2%

BYD Electronic (International) Company Ltd. 0.9%

China Yuchai International Ltd. 0.7%

Hanfeng Evergreen Inc. 0.6%

AJIS Company Ltd.  0.5%

Total Holdings 63.4%

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He mentioned the addition in his annual report

 

Guess I'm being dumb about this, but this is all I can find:

 

http://www.choufunds.com/pdf/AR11.pdf

 

Factors Influencing the 2011 Results

The portfolio had gains in the holdings of Sanofi and Next PLC. Securities in the portfolio that

declined most in 2011 were Aer Lingus Group, Topps Tiles, Nokia Corporation and the debt

securities of Hellenic Republic.

The Fund added equity securities of Abbey PLC, Heracles General Cement, The Governor and

Company of the Bank of Ireland, and the debt securities of Hellenic Republic and MannKind to the

portfolio; on the sell side, the Fund sold all shares of CryptoLogic and all its debt securities of

Global Crossing U.K. Finance. 

 

And that's noted for the "Europe Fund" - I must admit, I didn't read every word - just searched for Mannkind.

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Thought it was Asia but it may have been Europe.  Going off memory when I responed so I might have had the debt mixed up with stock.

 

The debt securities for mannkind still come due in 2013 and the company has set aside shares to convert the debt into stock.

 

 

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Thought it was Asia but it may have been Europe.  Going off memory when I responded so I might have had the debt mixed up with stock.

 

The debt securities for mannkind still come due in 2013 and the company has set aside shares to convert the debt into stock.

 

No problem... thanks for the clarification...

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  • 3 months later...

Rough Q2 2012 Call Notes - Apologies in advance for anything not clear or just plain wrong!

 

Mannkind 2012 Q2 Call

 

159.9 Million shares outstanding

32M dollars cash left.

58.9M including credit line from Al

Funding until Q4 2012

Nothing definitive re cash-raising

Litigation:

Company 2.8M shares issued + 225K shares.

Insurance company paid all cash settlement part.

Company denies all wrong-doing.

Clinical trials – screened > 87% + 83% for the two studies.

Expect screening to be done next month.

Have considerable experience with the product now

Have a lot of interest in the delivery system

New patent on micro-particles + usage – extends patents until 2031!

Very aggressive trial – FDA requested very poorly controlled patients!

On track for recruiting re the revised schedule

Trails should be done by 2nd Qtr next year and re-submission by Q3

Financing – nothing firm yet

Addresses glycemic problem in a natural way.

Relative insulin effectiveness is not much less than injected rapid acting insulins (meaning, need to give a little higher does for same impact?)

Most significant fact is that it will be an effective tool throughout the entire diabetic illness range – including type2, where the market is huge – (type1 – 5-6%, type2 is about 92% of the total)

70% of type2 currently don't use any insulin at all.

But all the current drugs that the 30% do use have limited effectiveness and side-affects – but no alternative currently.

Diabetic association recently updated guidelines to start insulin earlier than previously for early onset type2 patients.

And FDA has guided Mannkind to test these patients too in this trial.

Already showed, in a separate trial, type2's can gain good control, even if used with no carbs ingested.

15 patients have already completed the 171 trial

175 is a faster trial – starting a little later

Cash burn 10 to 12M per month.

By early next year, with trial winding down, will be about 8M per month.

But if winding up for commercialization, that could end up being higher.

Early trial results? No concerns / issues of hypo so far.

How long will the FDA review take? Expect it to take 6 months.

Partner will already in diabetes field? Don't have to be, but should have some endocrinological experience – open-minded about type of partner.

Want just US or world-wide? Looking for a global partner, but some strong regional partners have approached them – so not entirely discounted as an option.

Type2 trial, due to guidance from the FDA itself – said it would be a very valuable thing to do – would serve a very significant need

Planning to look at the early onset diabetes trial participants separately from the rest of the trial participants.

Al Mann: A lot going on, but not a lot we can discuss except for the trials – hope will have some interim updates before next Qtrly call.

 

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Rough Q2 2012 Call Notes - Apologies in advance for anything not clear or just plain wrong!

 

Mannkind 2012 Q2 Call

 

159.9 Million shares outstanding

32M dollars cash left.

58.9M including credit line from Al

Funding until Q4 2012

Nothing definitive re cash-raising

Litigation:

Company 2.8M shares issued + 225K shares.

Insurance company paid all cash settlement part.

Company denies all wrong-doing.

Clinical trials – screened > 87% + 83% for the two studies.

Expect screening to be done next month.

Have considerable experience with the product now

Have a lot of interest in the delivery system

New patent on micro-particles + usage – extends patents until 2031!

Very aggressive trial – FDA requested very poorly controlled patients!

On track for recruiting re the revised schedule

Trails should be done by 2nd Qtr next year and re-submission by Q3

Financing – nothing firm yet

Addresses glycemic problem in a natural way.

Relative insulin effectiveness is not much less than injected rapid acting insulins (meaning, need to give a little higher does for same impact?)

Most significant fact is that it will be an effective tool throughout the entire diabetic illness range – including type2, where the market is huge – (type1 – 5-6%, type2 is about 92% of the total)

70% of type2 currently don't use any insulin at all.

But all the current drugs that the 30% do use have limited effectiveness and side-affects – but no alternative currently.

Diabetic association recently updated guidelines to start insulin earlier than previously for early onset type2 patients.

And FDA has guided Mannkind to test these patients too in this trial.

Already showed, in a separate trial, type2's can gain good control, even if used with no carbs ingested.

15 patients have already completed the 171 trial

175 is a faster trial – starting a little later

Cash burn 10 to 12M per month.

By early next year, with trial winding down, will be about 8M per month.

But if winding up for commercialization, that could end up being higher.

Early trial results? No concerns / issues of hypo so far.

How long will the FDA review take? Expect it to take 6 months.

Partner will already in diabetes field? Don't have to be, but should have some endocrinological experience – open-minded about type of partner.

Want just US or world-wide? Looking for a global partner, but some strong regional partners have approached them – so not entirely discounted as an option.

Type2 trial, due to guidance from the FDA itself – said it would be a very valuable thing to do – would serve a very significant need

Planning to look at the early onset diabetes trial participants separately from the rest of the trial participants.

Al Mann: A lot going on, but not a lot we can discuss except for the trials – hope will have some interim updates before next Qtrly call.

 

Thank you for posting.  What's the total market in dollars for fast acting insulin in the US and worldwide?

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Rough Q2 2012 Call Notes - Apologies in advance for anything not clear or just plain wrong!

 

Mannkind 2012 Q2 Call

 

159.9 Million shares outstanding

32M dollars cash left.

58.9M including credit line from Al

Funding until Q4 2012

Nothing definitive re cash-raising

Litigation:

Company 2.8M shares issued + 225K shares.

Insurance company paid all cash settlement part.

Company denies all wrong-doing.

Clinical trials – screened > 87% + 83% for the two studies.

Expect screening to be done next month.

Have considerable experience with the product now

Have a lot of interest in the delivery system

New patent on micro-particles + usage – extends patents until 2031!

Very aggressive trial – FDA requested very poorly controlled patients!

On track for recruiting re the revised schedule

Trails should be done by 2nd Qtr next year and re-submission by Q3

Financing – nothing firm yet

Addresses glycemic problem in a natural way.

Relative insulin effectiveness is not much less than injected rapid acting insulins (meaning, need to give a little higher does for same impact?)

Most significant fact is that it will be an effective tool throughout the entire diabetic illness range – including type2, where the market is huge – (type1 – 5-6%, type2 is about 92% of the total)

70% of type2 currently don't use any insulin at all.

But all the current drugs that the 30% do use have limited effectiveness and side-affects – but no alternative currently.

Diabetic association recently updated guidelines to start insulin earlier than previously for early onset type2 patients.

And FDA has guided Mannkind to test these patients too in this trial.

Already showed, in a separate trial, type2's can gain good control, even if used with no carbs ingested.

15 patients have already completed the 171 trial

175 is a faster trial – starting a little later

Cash burn 10 to 12M per month.

By early next year, with trial winding down, will be about 8M per month.

But if winding up for commercialization, that could end up being higher.

Early trial results? No concerns / issues of hypo so far.

How long will the FDA review take? Expect it to take 6 months.

Partner will already in diabetes field? Don't have to be, but should have some endocrinological experience – open-minded about type of partner.

Want just US or world-wide? Looking for a global partner, but some strong regional partners have approached them – so not entirely discounted as an option.

Type2 trial, due to guidance from the FDA itself – said it would be a very valuable thing to do – would serve a very significant need

Planning to look at the early onset diabetes trial participants separately from the rest of the trial participants.

Al Mann: A lot going on, but not a lot we can discuss except for the trials – hope will have some interim updates before next Qtrly call.

 

Thank you for posting.  What's the total market in dollars for fast acting insulin in the US and worldwide?

 

That's the billion dollar question.

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  • 1 year later...

I read the beyond proxy article and it comes across as quite in-depth.  However, it ignores the elephant in the room which is the effect that inhaling this powder will have on the lungs.  It took me all of 3 minutes on google to find a study claiming that diabetic inhalation leads to amyloid buildup in your lung tissue.  I don't know.  If you go onto diabetes forums and start reading on it, that is the main issue people raise, what is the impact on the lung.  The bulls counter argument is, the inhaler is smaller, more convenient and the drug works better.  Nobody cares, they just want to know if it is going to have long-term effects on your breathing.  Diabetes isn't fatal, you could be taking this stuff for decades, so it's a really big issue.  I don't want to make the claim that it necessarily will hurt people's lungs, just that that is the real issue, and if you want to invest in the stock, start by convincing yourself that there is no new health risk. 

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no_free_lunch

 

You are right that the long term effect of inhaled insulin on lungs is unknown. Afrezza has been used in one shape or form for last 10+ years. No matter how good the product is, a good portion of patients will be turned off by this issue.

 

I had an email conversation with Dr Kayed year or two back

-----------------------------------

From: "Kayed, Rakez" <

Sent: Sun, August 15, 2010 11:37:15 AM

Subject: RE: amyloid aggregates article

 

Short answer; I do not know how it will affect other insulin inhalers, since we did not test them, and we do not know what happens in humans, since we did not have access to tissues from the lungs of humans who used the inhalers.

Our research focus is amyloid formation not drugs evaluation, in this study we were investigating protein aggregation at the interface, after our initial discovery that inhaled insulin forms amyloid in the lung, we performed many experiment in vitro, and we were surprised how poor the quality of the insulin encapsulated in these kits was. Its aggregation kinetics was worst that the recombinant insulin we bought in bulk. Still we hope our novel findings will insure that scientists and companies look more carefully at insulin aggregation both in vitro and in vivo.

We did not have access human tissues from people who used the inhalers. This is the first report describing these novel findings,thus we are sure that many researchers especially those who have access to human tissue will look at this phenomena in humans (remember humans are different than mice). Also we are confident that they will look more carefully at the quality of the insulin intended for human use to insure higher quality.

Also we were not able to test the clearance of amyloid in the lungs after discontinuing the treatment, because we did not have enough inhaled insulin to complete these experiments (Exubera was withdrawn from the market) we tried to obtain more kits by contacting Pfizer and Necktar directly with no success, still be believe that in mice the effects are irreversible because we found caspase activation.

 

Best Regards

 

rakez

Rakez Kayed, PhD

Assistant Professor

Department of Neurology

George and Cynthia Mitchell Center for Neurodegenerative Diseases

-----------------------------------------

 

My email

read your article "Inhaled Insulin Forms Toxic Pulmonary Amyloid Aggregates" with lot of interest. I'm not in research, but I'm a shareholder of Mannkind corporation. I'm trying to understand how your findings impact Mannkind's Afrezza.

 

As you may know, Afrezza is a proprietary FDKP with monomeric insulin. It is inhaled similar to Exubera. Both are different compounds.

 

1) Do you think inhaling afrezza will also cause amyloid aggregates?

2) In your study, the rats were subjected to Exubera for 7 days only, in Exubera trials patients were exposed for years and after the initial drop in FEV/PFT measurements, there was a non-progressive reversible decline in lung function. Why do you think in Exubera trials, over the years the amyloids didn't aggregate on and on and cause a continuous lung function decline?

 

I would really appreciate your feedback

----------------------------------------------------------------------------------

 

I've some more info on it from other knowledgeable posters. email me in private if you are interested

 

I've a small (speculative) position.

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3 years ago,  at our

board dinner meeting,  one of our board member asked Francis Chou how he valued MNKD. (Francis Chou had invested into stocks and bonds, actually he bought stocks twice)

He admitted that he made a mistake buying stocks, and he sold it with the loss. However,  he  has been making  money  with  bonds  he bought at big discount.

I don't invest in MNKD ,too speculative for me,  even though at may help a lot of people.  As Mr. Buffett said"as investor, however, our reaction to fermenting industry is much like our attitude towards space exploration,  we applaud the endeavor but prefer to skip the ride"

 

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