Showing posts with label manufacturing. Show all posts
Showing posts with label manufacturing. Show all posts

Thursday, July 2, 2015

Manufacturing Jobs vs. Waiters/Bartenders

Click on Image to Enlarge

Tuesday, September 7, 2010

ALXA and FDA inspection

This press release is potentially bullish for ALXA and AZ-004 FDA approval. Again, PDUFA date is October 11, 2010.

http://finance.yahoo.com/news/Alexza-Pharmaceuticals-to-prnews-2569073814.html?x=0&.v=1

"The PDUFA goal date for our AZ-004 (Staccato loxapine) NDA is October 11, 2010. During the past several months, the FDA has conducted and completed NDA-based inspections of our manufacturing facility, and several clinical and non-clinical sites, which appear to be part of the normal course of the ongoing NDA review," said Thomas B. King, Alexza President and CEO. "As we approach the PDUFA goal date, we expect continued interaction and contact with the FDA regarding our NDA submission. We are not planning on making any specific comments on the details of these interactions unless we feel we have material information that will impact our PDUFA date."

See disclaimers in the side bar.

Disclosure: long shares of ALXA.

Tuesday, August 3, 2010

ARNA Q2 earnings report

http://finance.yahoo.com/news/Arena-Pharmaceuticals-prnews-3737388002.html?x=0&.v=1
Arena Pharmaceuticals, Inc. (Nasdaq:ARNA - News) today reported financial results for the second quarter ended June 30, 2010, and recent developments, including the successful Pre-Approval Inspection, or PAI, of the company's Swiss drug product manufacturing facility by the US Food and Drug Administration, or FDA.

"We have recently achieved a number of important milestones, including the establishment of an agreement with Eisai for the commercialization of lorcaserin in the US, the successful completion of the FDA's pre-approval inspection of our Swiss manufacturing facility and the publication of our BLOOM trial results in the New England Journal of Medicine," stated Jack Lief, Arena's President and Chief Executive Officer. "We are continuing to execute on our plans for lorcaserin as we prepare for the September FDA advisory committee meeting and potential regulatory approval."

See disclaimers in the side bar.

Disclosure: long ARNA sharews.

Sunday, May 9, 2010

CEO's rank California dead last

California is killing the manufacturing industry according to a survey among CEO's.

http://www.investors.com/NewsAndAnalysis/Article.aspx?id=532309


Asked to rank states by business climate, CEOs put California dead last. Texas was No. 1.

• "Texas is pro-business with reasonable regulations while California is anti-business with anti-business regulations."

• "California is terrible. Even when we've paid their high taxes in full, they still treat every conversation as adversarial. It's the most difficult state in the nation. We have actually walked away from business rather than deal with the government in Sacramento."

• "The leadership of California has done everything in its power to kill manufacturing jobs in this state. If we could grow our crops in Reno, we'd move our plants tomorrow."

• "State politics seem consumed with how to divide a shrinking pie rather than how to expand it."

• "Union density is increasing, contrary to national trend, from 16.1% of workers in 1998 to 17.8% in 2002."

• "Unfunded pension and health care liabilities for state workers top $500 billion and the annual pension contribution has climbed from $320 million to $7.3 billion in less than a decade."

California's long-term job losses are downright ugly. Since 2001, while politicians dither and spend, 634,000 factory jobs have disappeared along with 34% of the industrial base. From 2003 to 2007 alone, according to the Milken report, 79,000 jobs were lost due to excessive regulation and too-high taxes.

But if California's private companies are suffering, its public sector sure isn't. From 2001 to 2009, California lost 235,000 net private-sector jobs, but gained 163,700 government jobs. Those cushy union jobs also pay more than comparable private jobs and provide gold-plated benefits. Now Californians find they actually have to pay for this foolishness.

Wednesday, July 29, 2009

NVAX

NVAX, a long-term influenza play, surged again today, despite no news. An FDA vaccine committee meeting is occurring today, but I don't expect any orders or EUA to come out of it. Without any major catalysts in the near-term horizon, I decided to take some profits, after effectively doubling my money in two months. I will leave the rest on the table as NVAX VLP technology gains traction in Spain and Indian, and potentially with the rest of the world. The NVAX value proposition is a faster time to vaccine manufacturing, higher yields, and reduced manufacturing cost from disposable systems.

Other swine flu companies are consolidating after a huge run up. I anticipate another leg up as awareness of its virulence gains media attention. It's all house money at this point, so I will let the market run its course into the fall flu season.

Saturday, July 12, 2008

Taxes and a competitive workforce

A sales tax would hurt lower income people. What we need is a flat income tax rate. It encourages investment and risk-taking among the well-to-do.

While taxes and tariffs hurt imports and exports, America's uncompetitive workforce is what's driving manufacturing jobs out of the country. There's no getting around that fact. It's empirical by definition. Think about it: if a company performs a site search for manufacturing facilities, they're going to take into account the cost of doing business in every location, domestic or offshore.

I've actually gone thru the process. I worked for a small, high-tech company in the early 90's, and we already had manufacturing facilities in Korea and the States. We kept our US plant for its proximity to our R & D team, but we ended up expanding into Costa Rica fdue to its high literacy rate, low-cost labor, tax incentives, time zone (vs. overnight difference in Asia) and English-speaking managers. It turned out we were the 2nd high-tech company to take advantage of the tax-free enterprise zone. Intel was the first.

The chase for the highest bang for your buck is in constant motion. At one time, Mexico, Japan, and Korea were the objects of our ire. Then it was China and India. Well, now they are losing jobs to countries like Vietnam, Malaysia and Indonesia. All have their pros and cons. But the bottom line is that as long as your workforce can climb the value chain (higher skills, higher knowledge, higher productivity), they won't be outsourced. American workers have not kept pace with that value curve.