If the regulators do end up demanding the confirmatory data from the EPP trial before approving, there's not much chance IMO we see this approved in 2010.
It takes a while just for Clinuvel to collect and analyze the confirmatory data...and this is assuming the spring trial even starts on time.
I think the current PPS reflects investors' belief that this is all being stretched out even further...again.
another delay ....., page-5
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