We Longs are all in that same boat. The point was that a trial with another drug is more difficult to prove in and must present statistically significant evidence of making a positive difference. Sounds simple enough but I just recently saw a drug that we know works fail because the end point was poorly defined. In our case proving superiority would be required and before you get int a P3 with that end point you must make sure that all of your ducks are lined up. And that includes production facilities which are identical to what you will be using for production if approved.
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