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DonDonDonDon

09/05/21 4:48 PM

#32930 RE: dloggold #32927

They would have held it up until all the data for 900 patients came in.
They had no business applying with data that was insufficient for EUA
Moving the goal posts is what happened here .


The ACTIV-5 trial data would not be part of HGEN's EUA application. The ACTIV-5 trial data are the government's data. HGEN's EUA application would be no different after 900 patients. Lenzilumab was a borderline case that required a deep dive by the FDA. It made sense for HGEN to apply when they did apply.

The original 200 patient ACTIV-5 hadn't completed when HGEN applied for the EUA. Obviously, the FDA were going to also look at the ACTIV-5 data when it did finish. Most drugs get the EUA if the FDA gives the green light to apply. I still believe that the EUA will come. Why would you be invested in a stock if you believe that the FDA are conspiring against it?