Comment by
realitycheck4u on Oct 09, 2020 12:41pm
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Comment by
ggg088 on Oct 10, 2020 8:55am
Who can estimate the time of the submission to FDA?
Comment by
SPCEO1 on Oct 10, 2020 11:18am
Based on what the company has said on this subject, sometime this week would be likely. The fact that they chose to release their Q3 financials later than normal tells me they are likely trying to have the protocol submitted by10/15 so they can announce that at the same time. But, these things are pretty complicated so don't be surprised if we have to wait a bit longer than 10/15.
Comment by
scarlet1967 on Oct 09, 2020 3:22pm
https://pubmed.ncbi.nlm.nih.gov/28832410/ [/quote]
Comment by
scarlet1967 on Oct 09, 2020 3:48pm
It sounded like he tried to link the outcome of the study to a healthy liver( reduction of inflammation/fibrosis)
Comment by
qwerty22 on Oct 09, 2020 4:28pm
It's a 2ndary analysis of the Lipo Ph3 patients looking at liver enzyme. Maybe I should look this up but what is the mechanism behind raised ALT/AST. Is that just dead/damaged hepatocytes releasing the enzymes? [/quote]