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biotech2010

08/12/15 2:13 PM

#2065 RE: thefamilyman #2057

-Why not just submit the question through the GALT blog and get a complete, accurate response? You were the one who mentioned this new communication channel for GALT
-Researcher means a physician who is an expert in this field, not someone they would hire.

Any change in a trial requires a filing with the FDA, some extend the time for the trial, some don't. I don't have a clue where increasing the test sites or researches falls but here is a link to some of the FDA protocol for this types of things, I trust GALT's science and design as it relates to these trials so have no reason to question any of this: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.30