8. Why has there been an announcement that only one patient has been recruited for phase 3 trials. Is there any problem with uptake.
They are not going to release a new ann for every new patient.
However I agree the process is very slow and leg behind the announced schedule, but my understanding the roadblocks are regularity and paper work.
June 2012
A Study Of Autologous Dendritic Cell Therapy
Study Status
• Approximately 1000 patients are to be
enrolled globally to ensure 800 patients pro
ceed to treatment.
• In Europe 9 countries have EC approvals
Austria, Estonia, France, Germany, Latvia,
Lithuania , Poland, Romania, Ukraine
Submissions to competent authorities are
underway
• In the US and Australia the study is approved
and sites are undergoing site initiations.
• 97 sites selected
• 2 sites in the US are actively enrolling and
one site in Australia
• 4 patients enrolled as of May 2012
• Complete enrollment projected for 4th
quarter of 2013
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