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Foxwoods Man

08/08/14 2:13 PM

#6220 RE: majatamata #6219

Nice find....interesting that the company with the product they call "voodoo science" is over $23/share

An excerpt for the thread:

CEL-SCI's change in contract research organizations ((CRO)) is resulting in faster enrollment: the company announced last month total patient enrollment of 232 people, more than one-quarter towards their goal of 880 by the end of next year. Critics complain that CEL-SCI cannot meet its target, but do not take into consideration acceleration of enrollment made possible by the number of countries and organizations for which trials have been and continue to be approved, with multiple sites available in each. In the past three months alone, Turkey, Austria, Sri Lanka, France and the UK have come on board, totaling 17 countries in all. This is truly a global trial - sites also include those in Canada, India, Israel, Poland, Hungary, Russia, Taiwan, Ukraine, Serbia, Croatia, and Bosnia and Herzegovina.

In the US, CEL-SCI gained approval from Detroit's Henry Ford Health System, one of the nation's largest group practices with over 1,200 doctors in 40 specialties. This followed 21st Century Oncology of Greenville, North Carolina, with 166 treatment centers in 16 states and six Latin American countries. My question is why would management, by keeping a running count of enrollees, hold itself up to public embarrassment and investor scorn if it did not fully expect to reach its desired enrollee numbers?

No doubt, CEL-SCI has a long road ahead, and a pivotal trial of this magnitude may quickly burn through its remaining cash, forcing it to seek dilutive financing. Its own clinical and regulatory risks notwithstanding, CEL-SCI faces upcoming competition from AstraZeneca, Merck and Bristol-Myers who plan studies in head and neck cancer, big firms with deep pockets. The I-O arena is also drawing critics: oncologists have gone on record urging caution concerning the results being churned out by Big Pharma, siting small sample sizes, lack of control groups, efficacy in only a minority of cancer patients, and bad side effects. Particularly when using two I-Os in combination for best results, a trend seen recently.

Regardless of risks, CEL-SCI is well-positioned to enter the I-O race. Head and neck cancer, including disease of the larynx, thyroid, salivary glands and nasal passages account for up to 5% of all cancers in the US,and cause 12,000 deaths per year, for a total market of slightly over $3 billion. Because of its prominent, visible position on the body, better agents are needed to reduce the size of tumors and limit the amount of disfiguring surgery. CEL-SCI is ahead of Big Pharma in filling this medical need, and given its undervalued status compared to competitors large and small presents a golden opportunity to take advantage of the budding I-O industry.