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Re: A deleted message

Monday, 02/26/2024 10:07:40 AM

Monday, February 26, 2024 10:07:40 AM

Post# of 176126
Well, you need to be fair. We do have more than zero communication. What we do know is that genotoxicity testing will last through at least mid-April and we only know that because they told us. That testing will probably drag to end of Apr to early May because things always seem to take more time. But we don't have any clue as to the complete list of items that must be accomplished before submitting the IDE. That is because the company doesn't have a clue as to what is on the list until the moment they are told they can submit. I too am frustrated, but with the FDA moving the goal post and not the company.

I appreciate Korenko trying to build the IsoPet business. He can't do any of the testing for IDE (not qualified) and can't market Radiogel because it isn't approved for any form of human use. We are paying him, I'm glad he is making some effort to earn that money.

He has decided to increase spending on more contractors and employees. I am sure that is a good sign, but the reality is it will increase costs. Until the IDE is submitted those increased those costs will likely be borne in some amount of dilution. So far that dilution hasn't been very large or impactful.
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