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Key information about 301 trial      5-Nov-09 10:54 am    
Below are comments made by the CEO in Sept after the 302 study failed. Note the CEO says in this article that the 301 study is DIFFERENT and they think better in light of what they found out during 302. So EVEN IF the FDA doesnt allow a change in the 301 trials design, the CEO still thinks it is already better. More evidence the AF article is wrong, that people arent doing their own DD and that the selling this week is misguided. Shame on "The Street" for not vetting their articles. Excellent reward/risk ratio right now with CHTP, a steal at this price.

Dr. Simon Pedder, Chelsea's President and CEO. "Further, we anticipate a more comprehensive review of the data will help determine the relative impact of a higher than anticipated placebo response and what, if any, additional factors may have contributed to these unexpected results. Key features to the design of this study included an initial 7-day open-label drug treatment period following dose titration and prior to a 14-day randomized withdrawal treatment period. While we intended to stabilize patients immediately prior to withdrawal, the observed decline in BP during this period appears to have had a negative effect on the study's ability to discern treatment effect. In addition, the benefits of Droxidopa, as measured by both BP and item 1 of the OHSA scale, appeared to persist to some extent despite absence of therapy, raising potential questions regarding the suitability of this type of trial design for an NOH study. We remain hopeful that the results of Study 301, which is a standard induction design study in which patients are washed out between titration and the blinded study, may provide a better opportunity to clearly demonstrate the efficacy of Droxidopa in this indication."
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Key information about 301 trial
hjertingii Not rated 5-Nov-09 10:54 am  
 
Shake some of those cobwebs out and try to underst...
anotherbubb... Rate it 5-Nov-09 11:31 am  
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Chelsea Therapeutics International Ltd. (CHTP)

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