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Re: Bud Powell post# 6038

Thursday, 07/09/2015 2:09:23 PM

Thursday, July 09, 2015 2:09:23 PM

Post# of 462513
Overseas trials are done for multiple reasons.

Most of the smart companies (typically with C levels with 15+ years of medical experience) are moving towards this strategy. Take a look at ADXS and NWBO.

To simplify it: it's easier; less regulation, lower costs, easier for patients to sign up, more institutional space available.

If positive results are achieved, it is extremely difficult for the FDA to reject an advancement to phase III just on the grounds of "you didn't conduct it here." However, this response has been acceptable for full FDA approval, so I would assume (should we advance) that the phase III would be conducted in the US.
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