iMO if the CLBP results are very good or better in the USA, especially given the current opioid crisis, that the FDA would look at an approval pathway based on current results... not to say they won’t want a confirmatory trial to happen as well but who knows ?
If all the results of our phase 3 trials are significant you would have to start to wonder at what point the FDA will stop making MSB jump through more and more hoops ? It is my understanding that in relation to CLBP we are already exceeding most pain trial periods by 12 months - I have seen other back pain trials for other treatments only have a 12 month duration .... happy to hear others opinions on this
iMO if the CLBP results are very good or better in the USA,...
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