For months on end, Neuralstem (CUR) has been pounding the table for the FDA to give the go-ahead for its phase II ALS trial. Ever since the company's final phase I patient, now world famous Ted Harada, got his injections of Neuralstem stem cells in 2011 to become the first person ever to have his ALS condition dramatically improve, the entire ALS community has been waiting with baited breath for phase II to begin.

This month, Neuralstem finally got the green light and has already filed the protocol for its phase II ALS stem cell trial. What was the hold up? The FDA was demanding a slower time frame than Neuralstem wanted for the dosing of patients as a safety precaution. In other words, for safety reasons, the FDA preferred to let ALS patients, with an average mortality rate of 2-5 years after diagnosis, wait. Just to be

In 2013 the biotechnology sector continued to advance, with the biotech index showing a rise of 24.1% in comparison with a rise of 9.1% for the S&P. Nevertheless, the strength in the sector is still not fully priced in. Despite the positive last two years, valuations for biotech firms remain attractive with average compounded earnings growth in 2012-15 equal to 18%. The key fundamental drivers are 1) late stage clinical trial success, 2) regulatory approvals of innovative products, 3) solid current business performance combined with strong growth prospects, 4) strong alliances with leading pharmaceutical companies. These fundamentals determine high stock price appreciation for a number of biotech companies.

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One of the most impressive gains was made by Celgene, Inc. (CELG) whose growth was driven by myelodysplastic syndromes (MDS) drug Revlimid (lenalidomide), which generated just over $1 billion, up 16%. Revlimid can also be expanded

For a development stage biotech, staying afloat is never a given and the options are not pretty as to how to go about it. Each company has its own strategy and each strategy has its own advantages and disadvantages. In this review I will go over four promising biotechs that are struggling to get their drugs to market, each one leading a different approach as to how to survive without any substantial revenue stream. I will point out the advantages and disadvantages of each approach in order to give you an idea of how each one might affect the given company's stock price in the event of success or failure.

Celldex ( CLDX ) strategy: Keep a nice capital cushion

At $900M, Celldex is quite large for a company with no sales revenue. Trading volume is consequently much higher than most of its competitors, as is liquidity in its share

There are a slew of phase I/II trials going on right now in the stem cell sector that could change the lives of millions of people. The biggest companies are never directly involved in these as they tend to be much more conservative with their cash hoards and stick with what works. The picture as I see it is that Big Pharma is letting the small speculative stem cell companies do the dirty work, bleed the cash, and grease the bureaucrats, while they wait to see which company shows the best results, if any.

In the past, significant success in phase II has attracted the attention of large companies offering buyouts as was the case with Amgen (AMGN) with Biovex in 2011, and in other cases an offer to shoulder the costs of phase III trials in exchange for future revenues. Either case is a dream for shareholders

The biotech field is a horn of plenty for those keen on understanding the nearly limitless scope of human ingenuity. From new drugs to new platforms and tools for treatment, to new genetic research that has cracked open entirely new vistas of research and development, the field is virtually ablaze with energy and activity.

And off in one corner of that vast laboratorial expanse lies a group of companies whose niche is circumscribed exclusively by the development of unique delivery systems for a variety of medications.

While it used to be that oral delivery, injection or IV were the principal methods of drug delivery, today transdermal patches, inhalation systems, creams and ointments vie with extended release capsules, continuous delivery systems and biodegradable polymeric-based delivery for the most efficient - and least disruptive - options for patients.

Below I've surveyed four companies working the drug delivery ward, each of whose stock

The biotech midcap market is unique on Wall Street. It is one of the most irrational, inherently unstable, and unpredictable markets out there. More so, I believe, than any other group of mainstream stocks you can trade today. Why is this? Though not so in every case, biotech midcaps are to a large extent made up of companies that only recently received a major FDA approval for a very promising drug, but have not successfully marketed the newly approved drug to the public yet. The FDA approval serves to dramatically increase the price of these stocks, bringing many of these companies from small cap to midcap in a very short time period. But clearly, as the marketing infrastructure for the new medicine has not been put in place, the positions of many of these companies are still tenuous and many continue to operate at a loss and even resort to

A NASDAQ listing is for many companies is the end of a long building process, for others it's the realization of a personal lifetime goal, and for others still, it marks the end of the line, the transfer of ownership and operation of an enterprise labored over, nurtured and invested in that now has to change hands in order to thrive.

When the next step is no longer in the realm of the entrepreneur's aptitude, if he's wise, he will pass his project on to other, more capable and experienced hands.

Such is the case with the following four companies, all of which listed to the NASDAQ this last month. Some came via Initial Public Offering, while others up-listed from a Bulletin Board home, the NASDAQ's 'junior', over-the-counter (OTC) trading system.

But regardless how they made it, the following crop of companies now stands to benefit from the

Stem-cell therapy is an intervention strategy that introduces new adult stem cells into damaged tissue in order to treat disease or injury. Medical researchers believe that stem-cell treatments can change the face of human disease and alleviate suffering. The ability of stem cells to self-renew can generate tissues that can replace damaged areas. Breakthroughs in this field led to outperformance of a number of cell therapy companies.

Cell therapy stocks clearly outperformed the market in 2012. Thus, StemCells, Inc. (STEM) rose by 108%, NeoStem Inc. (NBS) by 19.6%, and Osiris Therapeutics (OSIR) by 73.7%. Osiris obtained the approval of its product Prochymal in New Zealand and Canada, with a cell therapy as the main component for children with graft-versus-host disease (GVHD). This is a major accomplishment because it sets the stage for other cell therapy approvals in the future. The stock has since bolstered to a market cap of

It's never easy for companies in brand new industries to navigate early market trends and uncertainties. For pioneers of electric vehicle ((EV)) charging solutions, those challenges are multiplied by regulatory issues as well as the need to steer through a maze of government grants and to cooperate with global automakers.

That's why several EV charging companies are making sure to populate their boards of directors with people who can make a difference. Some companies are including outside directors with EV industry experience or industrial expertise. Others are looking to high-profile politically connected directors who can help a young company get an edge as the market evolves.

Coulomb Technologies, a privately held company that operates the ChargePoint Network for EVs in 14 countries, boasts the inclusion of Martin Eberhard on its board. As a co-founder of Tesla Motors (TSLA), Eberhard is well placed to help Coulomb

Here's a quick look inside a number of biotech players that have seen serious action recently, or that are due for a closer look in the near term.

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Stock in TrovaGene Inc. is getting a lot of attention these days, as the company's shares have been making new highs nearly every week for the last three and a half months. From lows set at the end of August just above $2.00, the stock has climbed rapidly to close at new highs of $6.25 this week. That's a full 25% higher than they were trading just three short sessions ago (see chart below).

So what's the news that's moving the stock?

It appears the market is getting excited about three separate issues, if, indeed, expanding volumes are indicative of excitement.

Take a look here:

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Trade on TROV jumped far above its average daily pace of 50,000

Biotech has vastly outperformed all three of the major indexes over the past year. Taking a look at a one-year chart of the Biotech (IBB), Dow (DIA), S&P (SPY), and Nasdaq (QQQ) ETFs, the clear winner by a landslide is IBB with over 23% gains for the year, its closest competitor being the Nasdaq itself at about 10.5%.

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The 5-year chart is a blowout with IBB beating QQQ by over 35%. Biotech wins out on almost every time frame, including the 10 year and even since the Nasdaq bubble popped 13 years ago. Here's a rundown of what I think are some of the more exciting, though volatile companies out there in this sector. Some you have probably heard of, and others that if you haven't yet, you will hear about now.

These stocks were picked not for their

In current times, biotechnology remains one of the few bright spots in the uncertain economic landscape. IBISWorld estimates that global biotechnology industry revenue will reach $228.6 billion in 2012, having increased at an average rate of 10.4% per annum over the past five years. As the nation's baby boomers continue to age, the demand for pharmaceuticals continues to grow and revenues of the biotechnology industry will increase at a compounded annual rate of 9 percent between 2012 and 2015. This is a marked turnaround from the 9% decline when the economy hit bottom in 2009.

The NASDAQ Biotechnology Index rose 10% in third quarter and is up 40.5% this year whereas S&P500 increase was only 12.1%. Although the $33 billion in biotech investment approached levels not seen since the venture boom 12 years ago in 2000, there is a major difference in the nature

Until recently, mobile marketing had consisted of big players like Google (GOOG) and Facebook (FB) sending out billboard-type ads to users based on demographics or search queries. If you were located in Des Moines, and you were looking for an all night pizza joint, Google's local mobile ads for DiMiastro's and Gianni's would find you when you did your search.

But would you find an ad?

Or maybe if you're the pizza-maker - Mr. DiMiastro or Mr. Gianni himself - and you're looking for local residents, or tourists in the 18 to 28 age range with disposable income, a past penchant for pizza, Facebook could find your cohort. They, after all, have a vast store of demographic data.

What if Mr. Gianni wants to offer a low discount at a particular time, would Google or Facebook find someone hungry for pizza at a particular hour? Or would they

"Necessity," the saying goes, "is the mother of invention." But there's another saying, one I will coin right now. "Simplicity," goes my saying, "is the father."

Since 1999, four new molecular entity (NME) drugs have been approved for use against bacterial skin infection. NME means that the molecule that is the active ingredient of the drug is newly engineered and never used before in any other approved medication. It is effectively invented in a lab. These NME's are Teflaro by Forest Labs (FRX), Tygacil by Pfizer (PFE), Invanz by Merck (MRK), and Vibativ by Theravance (THRX). In ophthalmology, four NME drugs have been approved for use against bacterial conjunctivitis. Zymaxid by Allergan (AGN), Besivance by InSite Vision (INSV), Azasite also by InSite, and Quixen by Santen. Only one FDA approved medication exists for bedsores, and that is Santyl

Northwest Biotherapeutics (NWBOD.OB) stock has seen some action recently. Without a doubt, this can be attributed to its latest press release about testing on its latest cancer treatment option, followed by news of the reverse split in its common stock.

Cancer is one of the most prevalent diseases in the modern era due to increasingly stressful lifestyles and contamination in our food, water and air. In essence, the latest trial from NWBO attempts to successfully treat cancers that are currently inoperable due to patients having multiple tumors and where surgery to remove tumors isn't recommended, amongst other reasons.

Should these trials be successful, speculators in the stock market won't be the only people filled with enthusiasm and hope for the future. The heart-warming patient stories on the company's website are worth having a look at.

On the operations side, things are certainly looking up with the company winning