While all things you say are some great positives,
Post# of 153847
(Total Views: 726)
Posted On: 10/26/2020 5:31:17 AM
Re: Lee Ron Lemab #63184
While all things you say are some great positives, if you don't have permission from the FDA to use the drug, that is separate from how you get that approval.
That is the challenge we have. Unblinding gets you a number, but are we really able to leverage it ? There are really only a handful of people that can give you an FDA approval. Think on that - a handful. The only thing that matters is - what do those people need to see.
This is not about a brute force attack. If it was - what are we attacking ? This is about strategy here that gets us only one result - an EUA. Not about showing R being less etc (Others will do that). Its about what does LL need to get an EUA.
What needs to happen is a) trial sights should expand b) accelerate trial signup c) try to get more S than C in the trial.
There will be a time to unbind and leverage that data, but without a clear plan or path to leverage that data, what do you gain ? Look at the EIND data, at such an early phase of this virus. Did anyone in main media care ? Why? If we haven't solved those issues (and other similar ones) how will unblinding at this stage get us closer to our goal of an EUA ? I am very confident there were people in the FDA that saw the results for the EIND's and the M/M trial and get it also. We need to equip those people to help us. They need data with sufficient N they can defend their opinion and fight for us the good fight.
Here is the other risk - what it may do is empower the shorts to attack us more (because they can use any weakness in the data or the feedback from the data to play on people's fear's.). What scares them - is this trial going 100% with a great outcome. Because that destroy's any fear / doubts in peoples minds (and that is always their goal).
That is the challenge we have. Unblinding gets you a number, but are we really able to leverage it ? There are really only a handful of people that can give you an FDA approval. Think on that - a handful. The only thing that matters is - what do those people need to see.
This is not about a brute force attack. If it was - what are we attacking ? This is about strategy here that gets us only one result - an EUA. Not about showing R being less etc (Others will do that). Its about what does LL need to get an EUA.
What needs to happen is a) trial sights should expand b) accelerate trial signup c) try to get more S than C in the trial.
There will be a time to unbind and leverage that data, but without a clear plan or path to leverage that data, what do you gain ? Look at the EIND data, at such an early phase of this virus. Did anyone in main media care ? Why? If we haven't solved those issues (and other similar ones) how will unblinding at this stage get us closer to our goal of an EUA ? I am very confident there were people in the FDA that saw the results for the EIND's and the M/M trial and get it also. We need to equip those people to help us. They need data with sufficient N they can defend their opinion and fight for us the good fight.
Here is the other risk - what it may do is empower the shorts to attack us more (because they can use any weakness in the data or the feedback from the data to play on people's fear's.). What scares them - is this trial going 100% with a great outcome. Because that destroy's any fear / doubts in peoples minds (and that is always their goal).
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