From another message board, these are some very in
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Posted On: 10/10/2020 10:03:33 PM
From another message board, these are some very interesting quotes. If taken at face value, leronlimab should be given EUA immediately or at a minimum, end of next week when we show statistical significance in CD12 interim analysis. Total and complete hypocrisy for any other result.
FDA Commissioner Hahn said this in an interview yesterday with Eric Topol:
https://webcache.googleusercontent.com/search...gl=us#vp_5
"if there are data available on any therapeutic that look like it could save a life during a pandemic, and it is safe and it fulfills the criteria of "may be effective," and the risk-benefit ratio is in the right direction, then we should go forward with it. But we intend to be transparent about the rationale behind an EUA, when and if it occurs, for therapeutics. We're going to have to encourage the sponsors to be transparent about the information we provide them, because we are restricted by law from releasing confidential commercial information. But we will, to the extent allowed, be very transparent about it.
But Eric, it is no different from vaccines with respect to needing to see data to make a decision about the criteria for an EUA. The decision is different. As you point out, because if this is for someone who's sick with COVID-19, that's different from someone who's healthy and doesn't have COVID-19."
FDA Commissioner Hahn said this in an interview yesterday with Eric Topol:
https://webcache.googleusercontent.com/search...gl=us#vp_5
"if there are data available on any therapeutic that look like it could save a life during a pandemic, and it is safe and it fulfills the criteria of "may be effective," and the risk-benefit ratio is in the right direction, then we should go forward with it. But we intend to be transparent about the rationale behind an EUA, when and if it occurs, for therapeutics. We're going to have to encourage the sponsors to be transparent about the information we provide them, because we are restricted by law from releasing confidential commercial information. But we will, to the extent allowed, be very transparent about it.
But Eric, it is no different from vaccines with respect to needing to see data to make a decision about the criteria for an EUA. The decision is different. As you point out, because if this is for someone who's sick with COVID-19, that's different from someone who's healthy and doesn't have COVID-19."
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