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Wednesday, January 07, 2026 2:11:55 PM
Mr. Rogers isn't wrong for interchanging "corrections" and "inquiries" in this particular instance.
The correct term the FDA uses (and was used in the PR from Korenko) is "comments." There are 63 comments for RadioGel.
The reason they use that word is because it is "softer" than "corrections" and vaguer than "inquiries." It's the same reason the FDA says "denied" rather than "rejected" as it is "softer" in context.
The FDA seeks corrections and inquiries when they issue feedback.
The real issue here is that a "groundbreaking" medical device that no other experienced company could apparently produce sat dormant for 13 years and then was "licensed" to a worthless OTC ticker that wasn't even a biotech. It then is another 13 years of "trying" to get an IDE.
Even though two other companies both had patents before Fishers on sol-gels and radioisotopes.
Tells you a lot.
The correct term the FDA uses (and was used in the PR from Korenko) is "comments." There are 63 comments for RadioGel.
The reason they use that word is because it is "softer" than "corrections" and vaguer than "inquiries." It's the same reason the FDA says "denied" rather than "rejected" as it is "softer" in context.
The FDA seeks corrections and inquiries when they issue feedback.
The real issue here is that a "groundbreaking" medical device that no other experienced company could apparently produce sat dormant for 13 years and then was "licensed" to a worthless OTC ticker that wasn't even a biotech. It then is another 13 years of "trying" to get an IDE.
Even though two other companies both had patents before Fishers on sol-gels and radioisotopes.
Tells you a lot.
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