To be fair Shelly, this does appear to be a set ba
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Posted On: 03/06/2021 12:51:23 PM
Re: Shelly2626 #81307
To be fair Shelly, this does appear to be a set back.
But IMO it is not a catastrophic set back. We still have very strong results, which on one else has. Its just not a slam dunk at this point.
And Its not a slam dunk because of the ratio of severe critical. I believe we may still get EUA because this is an issue of trial design (as was CD10). Both of which the FDA bears some of the responsibility too.
Designing a trial or an emerging health crisis has to be extraordinarily difficult. The FDA is going to give some latitude in these cases IMO. If this was a trial for a known disease the design would have been more precise.
At the end of the day those assuming we are going to get an EUA and those assuming we are not, are both as likely to be wrong. We dont know.
What we do know is that this drug has been proven to have an effect on Moderate disease, and critical disease. I assume that we will also find out that it has an effect on Severe. In my opinion, as you start connecting all of these dots it becomes pretty clear what is happening.
But IMO it is not a catastrophic set back. We still have very strong results, which on one else has. Its just not a slam dunk at this point.
And Its not a slam dunk because of the ratio of severe critical. I believe we may still get EUA because this is an issue of trial design (as was CD10). Both of which the FDA bears some of the responsibility too.
Designing a trial or an emerging health crisis has to be extraordinarily difficult. The FDA is going to give some latitude in these cases IMO. If this was a trial for a known disease the design would have been more precise.
At the end of the day those assuming we are going to get an EUA and those assuming we are not, are both as likely to be wrong. We dont know.
What we do know is that this drug has been proven to have an effect on Moderate disease, and critical disease. I assume that we will also find out that it has an effect on Severe. In my opinion, as you start connecting all of these dots it becomes pretty clear what is happening.
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