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Posted On: 11/11/2020 11:15:30 AM
Post# of 148984
Re: onestepahead #65013
BLA for s/c Would Take Months
EUA for s/c is quicker, but a doctor must submit paperwork in the EUA program, for each individual patient he wants to treat, send the app to the FDA and wait (maybe only days?).
What a hassle.
It seems that after we inject 293 in our s/c trial, if interim analysis results are compelling, with a great p value, it seems the FDA would change the protocol, somehow make an exception, and avail leronlimab to any doctor able to buy it (supply vs demand), due to the magnitude of the global crisis.
Such a decision/action would be compassionate, wise, prudent, moral, noble, grand, perceived as overdue.
EUA for s/c is quicker, but a doctor must submit paperwork in the EUA program, for each individual patient he wants to treat, send the app to the FDA and wait (maybe only days?).
What a hassle.
It seems that after we inject 293 in our s/c trial, if interim analysis results are compelling, with a great p value, it seems the FDA would change the protocol, somehow make an exception, and avail leronlimab to any doctor able to buy it (supply vs demand), due to the magnitude of the global crisis.
Such a decision/action would be compassionate, wise, prudent, moral, noble, grand, perceived as overdue.
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