I agree. We were all blindsided by the small num
Post# of 154979
(Total Views: 471)
Posted On: 03/07/2021 2:13:04 PM
I agree. We were all blindsided by the small number of critical patients. It was the missing piece of info when we were running our numbers. I'm still shocked out how out of balance the trial was.
It is also the reason IMO that the FDA isn't giving EUA. (We don't know this for a fact, but certainly appears to be the case). So we have to get more patients.
It sucks. It means we have to wait longer in the US. And it means our short term hopes now lie with other countries. They may very well approve and order product before the US. But having less shots on goal isn't great.
But it is what it is. All we can do is get back to work. I hope the pandemic goes away in the coming months, but it sounds unlikely.
Atleast we have another signal that it works. So, as we are filling the trial and approaching the completion I will have more confidence in the results. With that said, we are now in danger of other drugs getting to market first.
I don't think we can spin this as something great. It is a set back. But, the situation is fluid and could change quickly if another country pulls the trigger. I have no idea what to expect tomorrow, or in the coming weeks. We will just have to see what happens.
It is also the reason IMO that the FDA isn't giving EUA. (We don't know this for a fact, but certainly appears to be the case). So we have to get more patients.
It sucks. It means we have to wait longer in the US. And it means our short term hopes now lie with other countries. They may very well approve and order product before the US. But having less shots on goal isn't great.
But it is what it is. All we can do is get back to work. I hope the pandemic goes away in the coming months, but it sounds unlikely.
Atleast we have another signal that it works. So, as we are filling the trial and approaching the completion I will have more confidence in the results. With that said, we are now in danger of other drugs getting to market first.
I don't think we can spin this as something great. It is a set back. But, the situation is fluid and could change quickly if another country pulls the trigger. I have no idea what to expect tomorrow, or in the coming weeks. We will just have to see what happens.
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