FDA issues new guidelines for surrogate endpoints
Post# of 72440
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Posted On: 12/20/2018 9:22:09 AM
FDA issues new guidelines for surrogate endpoints in cancer trials, talks about how important it is for companies to meet with them to be sure clinical trials are designed in a way that will make it possible for FDA to accept their results.
https://www.fda.gov/NewsEvents/Newsroom/FDAIn...628853.htm
As applied to IPIX, this will help when the Kevetrin oral formulation trials start.
BUT -- RIGHT NOW -- does this shed a little light on how incredibly important IPIX's statement that the FDA was "collaborative" is? Green light from the FDA really means something important.
https://www.fda.gov/NewsEvents/Newsroom/FDAIn...628853.htm
As applied to IPIX, this will help when the Kevetrin oral formulation trials start.
BUT -- RIGHT NOW -- does this shed a little light on how incredibly important IPIX's statement that the FDA was "collaborative" is? Green light from the FDA really means something important.
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