Saturday, May 12, 2007
Cobalis Corp (CLSC.OB) - speculative
The twin trials are completed, and all of the data from the 23 sites has been collected and is being audited.
In March the company announced that it has completed the locking of the database for its pivotal twin Phase III Clinical Trials of PreHistin(TM) in seasonal allergic rhinitis. An independent contract research organization (CRO) will now begin the process of implementing the statistical analysis plan designed to analyze the data from the pivotal trials.
"We are pleased to have reached this milestone in our PreHistin trials and look forward to reporting top-line results over the next month," commented Dr. Gerald J. Yakatan, Chief Executive Officer for Cobalis Corp. "These twin trials represent two of the largest clinical trials conducted utilizing this novel anti-allergy approach. Our goal is to be able to offer a new, over-the-counter anti-allergy treatment option for allergy sufferers that goes beyond currently available remedies."
The 1,551-patient pivotal Phase III trials investigated the efficacy and safety of treatment with Cobalis' PreHistin on moderate to moderately severe seasonal ragweed allergy patients. The twin trials were designed to support regulatory approval in the United States and key global markets. The studies' primary endpoint is the average improvement in total nasal symptom score (TNSS) in weeks four, five and six of treatment. To observe duration of effect after treatment, patients maintained diaries for symptomology over the final four weeks of the ten-week study.
Very good presentation in November of 2006 here to give you more details on the company:
http://www.wsw.com/webcast/rrshq10/clsc.ob/
If the results are good, I expect the share price to at least double from these levels. ($1 - $1.05 currently)
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