: What is the definition and significance of administration of "Compassionate Use Drug"? There seems to be some conflict about the use of "Compassionate Drug Authorizations". Does the request and use of such a drug

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What is the definition and significance of administration of "Compassionate Use Drug"?
There seems to be some conflict about the use of "Compassionate Drug Authorizations".
Does the request and use of such a drug indicate that a patient is in extreme danger?
Barkground:
The FDA appears to define 'compassionate use authorizations' LINK as:

Expanded access, sometimes called "compassionate use," is the use of investigational new drug products outside of clinical trials to treat patients with serious or immediately life-threatening diseases or conditions when there are no comparable or satisfactory alternative treatment options.

and the same FDA documment specifies:

Patient(s) have a serious or immediately life-threatening disease or condition, and there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition;

However, the CEO of Regeneron (manufacturer of the experimental drug) recently said that (I am paraphrasing), 'Compassionate Use' is actually not as auspicious as it sounds, it actually means that the patient is in a "single user trial" (does not imply that the patient is in serious or life-threatening circumstance)
So, in actual clinical application, which is the accurate position?
If the former (the published FDA position) then there could be real concern that a patient is in significant danger of a life-threatening illness, however if the latter (the Regeneron statement) is accurate, then then there would be no concern that the patient is in great danger.

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