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Hopefully the coverage will be better than the coverage for Dexcom. As I understand it, Freestyle Libra will be much cheaper than Dexcom.

Per Matt B, "The Dexcom G6 coming in 2017 sounds like it might be a great (but expensive) alternative to the Libre.".

afrezzadownunder.com/2015/09/freestyle-libre-update/

Does the following fits Mannkind? I think so. I think it is good that Mannkind is nimble and small right now. Mannkind 1.0 did not work. Hope Matt, Mike and the team execute Mannkind 2.0 and 3.0 well!

“Good and Bad Capital”

www.morgannoble.com/strategy/good-and-bad-capital/

Clayton Christensen, Harvard professor and disruptive change and innovation expert explains: “At a basic level, there are two goals investors have when they put money into a company: growth and profitability. Neither is easy. Professor… showed… 93 percent of all companies that ultimately become successful had to abandon their original strategy— because the original plan proved not to be viable. In other words, successful companies don’t succeed because they have the right strategy at the beginning; but rather, because they have money left over after the original strategy fails, so that they can pivot and try another approach. Most of those that fail, in contrast, spend all their money on their original strategy— which is usually wrong. The theory of good money and bad money essentially… work as a simple assertion. When the winning strategy is not yet clear in the initial stages of a new business,

…good money from investors needs to be patient for growth but impatient for profit. It demands that a new company figures out a viable strategy as fast as and with as little investment as possible— so that the entrepreneurs don’t spend a lot of money in pursuit of the wrong strategy. Given that 93 percent of companies that ended up being successful had to change their initial strategy, any capital that demands the early company become very big, very fast, will almost always drive the business off a cliff instead.

A big company will burn through money much faster, and a big organization is much harder to change than a small one. Motorola learned this lesson with Iridium.

…That is why capital that seeks growth before profits is bad capital. But the reason why both types of capital appear in the name of the theory is that once a viable strategy has been found, investors need to change what they seek— they should become impatient for growth and patient for profit.”

Once a profitable and viable way forward has been discovered— success now depends on scaling out this model. (pp. 87-88). Harper Collins, Inc. from “How Will You Measure Your Life?

realmoney.thestreet.com/articles/01/12/2017/insulin-drug-offers-hope-mannkind

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Cost to Develop and Win Marketing Approval for a New Drug Is $2.6 Billion

csdd.tufts.edu/news/complete_story/pr_tufts_csdd_2014_cost_study

November 18, 2014

BOSTON – Nov. 18, 2014 – Developing a new prescription medicine that gains marketing approval, a process often lasting longer than a decade, is estimated to cost $2,558 million, according to a new study by the Tufts Center for the Study of Drug Development.

The $2,558 million figure per approved compound is based on estimated:

Average out-of-pocket cost of $1,395 million

Time costs (expected returns that investors forego while a drug is in development) of $1,163 million

Estimated average cost of post-approval R&D—studies to test new indications, new formulations, new dosage strengths and regimens, and to monitor safety and long-term side effects in patients required by the U.S. Food and Drug Administration as a condition of approval—of $312 million boosts the full product lifecycle cost per approved drug to $2,870 million. All figures are expressed in 2013 dollars.

The new analysis, which updates similar Tufts CSDD analyses, was developed from information provided by 10 pharmaceutical companies on 106 randomly selected drugs that were first tested in human subjects anywhere in the world from 1995 to 2007.

“Drug development remains a costly undertaking despite ongoing efforts across the full spectrum of pharmaceutical and biotech companies to rein in growing R&D costs,” said Joseph A. DiMasi, director of economic analysis at Tufts CSDD and principal investigator for the study.

He added, “Because the R&D process is marked by substantial technical risks, with expenditures incurred for many development projects that fail to result in a marketed product, our estimate links the costs of unsuccessful projects to those that are successful in obtaining marketing approval from regulatory authorities.”

In a study published in 2003, Tufts CSDD estimated the cost per approved new drug to be $802 million (in 2000 dollars) for drugs first tested in human subjects from 1983 to 1994, based on average out-of-pocket costs of $403 million and capital costs of $401 million.

The $802 million, equal to $1,044 million in 2013 dollars, indicates that the cost to develop and win marketing approval for a new drug has increased by 145% between the two study periods, or at a compound annual growth rate of 8.5%.

According to DiMasi, rising drug development costs have been driven mainly by increases in out-of-pocket costs for individual drugs and higher failure rates for drugs tested in human subjects.

Factors that likely have boosted out-of-pocket clinical costs include increased clinical trial complexity, larger clinical trial sizes, higher cost of inputs from the medical sector used for development, greater focus on targeting chronic and degenerative diseases, changes in protocol design to include efforts to gather health technology assessment information, and testing on comparator drugs to accommodate payer demands for comparative effectiveness data.

Lengthening development and approval times were not responsible for driving up development costs, according to DiMasi.

“In fact,” DiMasi said, “changes in the overall time profile for development and regulatory approval phases had a modest moderating effect on the increase in R&D costs. As a result, the time cost share of total cost declined from approximately 50% in previous studies to 45% for this study.”

The study was authored by DiMasi, Henry G. Grabowski of the Duke University Department of Economics, and Ronald W. Hansen at the Simon Business School at the University of Rochester.

I guess the IBB index fund re-balancing is occurring now. 

A bit less than 100. On the conference call, Mike said Mannkind had 42 sales people at that time. And not all of the current 54 openings are for sales people. So I guess Mannkind will have around 80-90 sales people if all the current openings are taken.  

Spiro does not use a CGM. Sam in the tudiabetes.org does not user a CGM. Robyn Jarrell does not seem to use a CGM. And I think there are other members in Sam Finta's report group that does not use a CGM.