I think you are correct on this EvilRbt. We see
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Posted On: 08/13/2020 9:53:42 AM
Re: Evil Rabbit #49085
I think you are correct on this EvilRbt.
We seem to be the first in mild/moderate. And, that is important, but not as "sexy"
as saving lives or preventing intubation.
As I slept on this, I woke up understanding that this MM trial simply had too many patients who were mild. This is why, at some point, one of our doctors/supporters started mentioning a third category (moderate to severe).
I think our team has now begun to define that category as people presenting with a NEWS score of 4 or more.
I like Dr Z's discussion of why we should get a EUA (using the textbook definition). NP however, has begun to hedge saying that we may not really have an unmet need at this level. He is suggesting that the unmet need is that those people can still spread the disease. That may be kind of a thin argument.
It is the kind of argument that gets "accepted" if the listener is predisposed to say yes. And, rejected if the listener is predisposed to say no. So, we are back to hoping that FDA is all about goodness and ending the pandemic.
I hope we get EUA and some type of simultaneous Phase 3. Would be a shame to be forced to wait 45++ days for the Critical trial to fill and go 28 days.
I also have some hope that the foreign country "threat" of soaking up the drug supply might push FDA to "lean yes."
We seem to be the first in mild/moderate. And, that is important, but not as "sexy"
as saving lives or preventing intubation.
As I slept on this, I woke up understanding that this MM trial simply had too many patients who were mild. This is why, at some point, one of our doctors/supporters started mentioning a third category (moderate to severe).
I think our team has now begun to define that category as people presenting with a NEWS score of 4 or more.
I like Dr Z's discussion of why we should get a EUA (using the textbook definition). NP however, has begun to hedge saying that we may not really have an unmet need at this level. He is suggesting that the unmet need is that those people can still spread the disease. That may be kind of a thin argument.
It is the kind of argument that gets "accepted" if the listener is predisposed to say yes. And, rejected if the listener is predisposed to say no. So, we are back to hoping that FDA is all about goodness and ending the pandemic.
I hope we get EUA and some type of simultaneous Phase 3. Would be a shame to be forced to wait 45++ days for the Critical trial to fill and go 28 days.
I also have some hope that the foreign country "threat" of soaking up the drug supply might push FDA to "lean yes."
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