Maybe there are tough choices to be made on this "

Maybe there are tough choices to be made on this "pathway to regulatory approval" topic.

An interesting article that I read on "the other side of the tracks" board:

https://agencyiq.com/the-twenty-two-regulator...-patients/

The CTAP route is the most obvious.

But the question about if EUA is requested that it goes down "Approval Cul-De-Sac Lane" and long term/permanent approval chances are significantly reduced.

Quote:

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“EUAs typically are not authorized with significant clinical data or assurances as to their safety or efficacy, and it can be difficult to convert an EUA to a full approval, as use of a product under an EUA doesn’t lend itself to collecting the type of clinical evidence needed to support full approval. Very few drugs or biological products qualify for this authorization pathway, though it is used extensively for medical devices and diagnostics, which generally present less risk to a patient. A sponsor is under no obligation to sell the product authorized for use, and the FDA is not able to compel them to do so.”

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