not sure to me but why wasn''t the last trial good enough to an approval process? why another phrase 3 ?
so we will have 12months trial ?.... but thats from the start time it may take time to get a cohort?
maybe they can use past patients? would be great to see what happens in a follow up injection, and could it be done in Europe too?
so more that 12 months wait, then to get data looked at 6 months more...so could end up 2 years before getting back to FDA...
have i got any of that off the mark?
can we get some sort of approval to use along the way... Emergency Use, with Opiod epidemic
i supposse good news for now
Ann: 36-Month Results of Phase 3 Trial in Chronic Low Back Pain, page-14
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