You may be correct however the FDA rejecting a pro
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Posted On: 06/11/2022 1:14:58 PM
You may be correct however the FDA rejecting a protocol submission and recommending additional changes and resubmittal may not be considered a material event. The definition of a material event is very subjective at best. Knowing what we've seen, or haven't seen, in the last 5 months, I wouldn't expect current mgmt to PR a protocol submittal. It's been several months and they still haven't PR'd the 700mg NASH results.
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a rejection from a regulatory agency has to disclosed to shareholders and it will affect the sp negatively anyway, and vice versa.
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My comments are just my opinions and should NOT be taken as investment advice.
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