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Tuesday, March 18, 2014 3:39:00 PM
"If there was an arrangement with the FDA that the PEI would get access to P3 interim data, then an approval by Germany based on P3 interim would necessarily signal to NWBO that the results are good." --- Ming
Consider the importance the FDA places upon Licensing applications:
Discussion of such an action [NWBO fire-walled employee(s) access to Interim Data] with FDA in advance. This is particularly advisable when the sponsor intends to use the study in support of a licensing or marketing application. Section 6.5
Moreover, the PEI is independent, and while their approval "signals" good things to everyone on the planet, so does Robert Demeger's health. By no means is either one definitive regarding how the DMC will rule.
Respect Risk. Conduct Your Own Due Diligence. Manage your assets wisely. Diversify.
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