The LH trial filled quickly we should have enrolled more. I predict we will be having a discussion at the end of July with some piece(s) of juicy data from the trial that hits something way out of the park, and we will all be wishing if we had only enrolled 150 or 200 instead of 50 we would have some crazy p=0.0001 or something, but now we will have to get a new trial approved to confirm and take another 4-6 months to get the trial approved, enrolled, run, analyzed, report generated and submission to FDA to get in line for a 2 month wait for an answer. I know its a ph2 trial, but there has been a lot of foot stomping on why we didnt get EUA on CD10 which was p2/3.
There is so much possible with this dang thing!! The best shot seems to be Philippines because their govt is so unstable and manipulatable by one or a few guys. My feel is that every other country we are talking with has much more regulatory state and friction to just having one person make a decision and get something done.
No one in the US FDA wants to be a hero. Its all status quo. Keep your head down, dont rock the boat, dont risk anything. Even with LL being safer than placebo which in my mind is reason enough to give to people to counteract problems with SOC treatments.
Everyone talks about hitting a p value for EUA. Are there two separate values for EUA vs approval? If there is no difference in the numbers we are trying to hit, what is the purpose of EUA?
There is so much possible with this dang thing!! The best shot seems to be Philippines because their govt is so unstable and manipulatable by one or a few guys. My feel is that every other country we are talking with has much more regulatory state and friction to just having one person make a decision and get something done.
No one in the US FDA wants to be a hero. Its all status quo. Keep your head down, dont rock the boat, dont risk anything. Even with LL being safer than placebo which in my mind is reason enough to give to people to counteract problems with SOC treatments.
Everyone talks about hitting a p value for EUA. Are there two separate values for EUA vs approval? If there is no difference in the numbers we are trying to hit, what is the purpose of EUA?
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