As much as I don’t like your bold statement that there will not be any EUA on Tuesday. I can see your point of view.
I mostly see your view and my view of the FDA being somewhat different. They have flat let down the American public and the world with approving drugs from companies that used smoke and mirrors to show any possible efficacy. Probably politically influenced most likely. But did these companies say. Whoa... we don’t want to be thought of as promoting our drug even though it hasn’t really showed any efficacy. Let’s create a little smoke screen and say we can’t explain the science because it shows nothing in normal marker indications but somehow it miraculously sends people home days earlier like it has some beneficial effect we just can’t explain. We all knew that this was going to come back and haunt these greedy pharmaceutical companies that have nothing to offer but some kind of hope and a drug that doesn’t really work.
Now we are in the position that even if small efficacy and I don’t believe our trial will show only small efficacy improvement for morbidity. But if it were to show small improvement over placebo... we still won’t get recognition from a gun shy FDA who is afraid to make another mistake. That would be sad in my opinion. It’s time to right the ship and make a bold approval that will change the fate of the people that need it most. There is no excuse now to hide your head in the sand and be afraid. Your reputation can only approve. You can’t damage it any further. Take a risk and save some lives and approve a drug that is safe and works. The people will demand it if it’s true. Releasing results could backfire on the FDA.
Worst case scenario. Let the people know they have a drug coming that in a few short weeks with open to the public efficacy results that will save lives in the completion of the trial. A trial that fills and completes in a short 5-6 weeks because of the press the first real confirmed drug to show positive results in morbidity has been trialed and mid term analysis show through lab results and lives saved that it works and has science to back up the amazing trial results.
Am I just dreaming? Isn’t this how the world should work? Why can’t this happen this way if it’s true. Please don’t respond to my rant. The world is never as we hope it should be. Leadership isn’t real like it use to be. The people in charge have let us down so far. Why would they stand up now and change our expectations?
I guess we can only hope... that’s what I will do... is still hope for people doing the right thing for the right reasons. It is what we all should expect.
Tuesday... there is still a chance we have a EUA. I won’t accept any other theory that says we won’t have that chance.
I mostly see your view and my view of the FDA being somewhat different. They have flat let down the American public and the world with approving drugs from companies that used smoke and mirrors to show any possible efficacy. Probably politically influenced most likely. But did these companies say. Whoa... we don’t want to be thought of as promoting our drug even though it hasn’t really showed any efficacy. Let’s create a little smoke screen and say we can’t explain the science because it shows nothing in normal marker indications but somehow it miraculously sends people home days earlier like it has some beneficial effect we just can’t explain. We all knew that this was going to come back and haunt these greedy pharmaceutical companies that have nothing to offer but some kind of hope and a drug that doesn’t really work.
Now we are in the position that even if small efficacy and I don’t believe our trial will show only small efficacy improvement for morbidity. But if it were to show small improvement over placebo... we still won’t get recognition from a gun shy FDA who is afraid to make another mistake. That would be sad in my opinion. It’s time to right the ship and make a bold approval that will change the fate of the people that need it most. There is no excuse now to hide your head in the sand and be afraid. Your reputation can only approve. You can’t damage it any further. Take a risk and save some lives and approve a drug that is safe and works. The people will demand it if it’s true. Releasing results could backfire on the FDA.
Worst case scenario. Let the people know they have a drug coming that in a few short weeks with open to the public efficacy results that will save lives in the completion of the trial. A trial that fills and completes in a short 5-6 weeks because of the press the first real confirmed drug to show positive results in morbidity has been trialed and mid term analysis show through lab results and lives saved that it works and has science to back up the amazing trial results.
Am I just dreaming? Isn’t this how the world should work? Why can’t this happen this way if it’s true. Please don’t respond to my rant. The world is never as we hope it should be. Leadership isn’t real like it use to be. The people in charge have let us down so far. Why would they stand up now and change our expectations?
I guess we can only hope... that’s what I will do... is still hope for people doing the right thing for the right reasons. It is what we all should expect.
Tuesday... there is still a chance we have a EUA. I won’t accept any other theory that says we won’t have that chance.
9
