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PITrader87

06/25/21 10:58 AM

#30565 RE: 10nisman #30563

I know I'm wasting my own time trying to reason with you because it's glaringly obvious what your MO is here, but that attempt at an argument is riddled with fallacies.

What does Actemra's past use and trials have to do with a future Lenz approval?

The drugs would be administered at different stages of the disease progression with Lenz being prescribed BEFORE Actemra. You're attempting to compare two entirely different drugs.

HGENs P3 trial was adequately powered per the FDAs stated requirements, FDA gave them the go ahead to apply for EUA, and the trial met significance in their unique primary endpoint that will fill a niche in the treatment landscape that has not yet addressed by other drugs. As a added plus, the NIH BET trial should be providing some more data in the coming days as well.

Everyone here understands there is always risk involved with any FDA decision, but there is nothing you have presented over the last month or so of your FUD campaign that has raised even an ounce of concern in my eyes.