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papaphilip

08/31/21 4:06 PM

#32813 RE: Engineering_Simple #32811

Thus the frustration. The silence. In listening to Cameron, he apparently doesn't know what's causing the delay either. I take him at his word, and that's ridiculous that the CEO isn't aware of what the hold up is. The fact that they haven't been denied the EUA can be taken as a good sign, but there should be more feedback between the FDA and company as per where it stands.
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cowtown jay

08/31/21 5:36 PM

#32818 RE: Engineering_Simple #32811

I haven't seen anybody say they know why the EUA is delayed.

But it's important to me to want to know why we don't have our approval. The delay is causing preventable deaths. And it's costing Humanigen and their shareholders money, posing a risk of bankrupting the company.

The FDA is not a rogue agency. They are subject to oversight, and this delay should cause the exercise of that oversight, whether it is from the Inspector General, or from the Secretary of the HHS.

It's only a matter of time before a non-revenue producing company runs out of money. At that time, we will no longer qualify for an EUA. We will fail to meet CMC requirements.

I don't understand the hostility and derision directed toward those of us who don't want to passively observe our destruction.