Sean, Sean,Sean,
Don’t you read the statistics? We didn’t pass our primary end point. Do you understand what that means? The FDA is well within their guidelines to make their statements. They could of showed us some respect and mentioned our small results of our 62 critical people in the subdivision of our trial. But they did tell everyone that is used for trial protocol to design another primary end point.
My frustration today is hearing all this negative sh_t about what we can do to the FDA and the reality is we could only beg for forgiveness if we knew what was the smart thing to do. We are not going to fail at anything and our investment is going to be ok. We don’t need to attack the FDA or anyone.
We just need to follow our path chosen before this week and go internationally with our drug. It seems to have caught a few companies and countries attention. WE WILL BE OK...OUR FUTURE IS OK. We are looking at revenue soon in one of 3 countries. We should be betting on which one first and not listening to people wanting to do crazy sh_t to the FDA.
It reminds me of a childhood saying when in grade school when you didn’t like what someone said to you...
I am rubber and you are glue... whatever you say bounces off of me and sticks to you!
Do you know who the person is that is rubber? That would be the FDA. Whatever we say to them... will come back to haunt us and stick to us and cloud our future in this country. The FDA has guidelines and they are within them. We have a pretty please attempt at wanting a EUA and we turned it into a demanding event and now we can be outraged they didn’t do what we asked??? Really? Count our lucky blessings we are still able to get our trial protocols finished so we can move forward on covid and other indications
Maybe we should sue them for... for... for... not Listening to our demands of giving us a free pass EAU? How would we frame that? Little Johnny got one and we didn’t... how child like is our mentality? Maybe, we are need to sue... a lawsuit is the wrong path as much as continuing with trying to correct a wrong we have no control over. A lawsuit would stop all progress I assume. We will get by just fine going internationally. Do you believe in the drug? If you do... you just need to let the path of the Brazil trial prove your point. In the mean time we are well on our way internationally.
Don’t you read the statistics? We didn’t pass our primary end point. Do you understand what that means? The FDA is well within their guidelines to make their statements. They could of showed us some respect and mentioned our small results of our 62 critical people in the subdivision of our trial. But they did tell everyone that is used for trial protocol to design another primary end point.
My frustration today is hearing all this negative sh_t about what we can do to the FDA and the reality is we could only beg for forgiveness if we knew what was the smart thing to do. We are not going to fail at anything and our investment is going to be ok. We don’t need to attack the FDA or anyone.
We just need to follow our path chosen before this week and go internationally with our drug. It seems to have caught a few companies and countries attention. WE WILL BE OK...OUR FUTURE IS OK. We are looking at revenue soon in one of 3 countries. We should be betting on which one first and not listening to people wanting to do crazy sh_t to the FDA.
It reminds me of a childhood saying when in grade school when you didn’t like what someone said to you...
I am rubber and you are glue... whatever you say bounces off of me and sticks to you!
Do you know who the person is that is rubber? That would be the FDA. Whatever we say to them... will come back to haunt us and stick to us and cloud our future in this country. The FDA has guidelines and they are within them. We have a pretty please attempt at wanting a EUA and we turned it into a demanding event and now we can be outraged they didn’t do what we asked??? Really? Count our lucky blessings we are still able to get our trial protocols finished so we can move forward on covid and other indications
Maybe we should sue them for... for... for... not Listening to our demands of giving us a free pass EAU? How would we frame that? Little Johnny got one and we didn’t... how child like is our mentality? Maybe, we are need to sue... a lawsuit is the wrong path as much as continuing with trying to correct a wrong we have no control over. A lawsuit would stop all progress I assume. We will get by just fine going internationally. Do you believe in the drug? If you do... you just need to let the path of the Brazil trial prove your point. In the mean time we are well on our way internationally.
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