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mc73

09/19/22 2:56 PM

#151034 RE: wrinklesobw #151033

I hope not, we are likely a year away from IDE submittal, let alone approval. All the tumor growing and testing takes time, and FDA needs to schedule the next meeting which could take another month or 2 - all imo
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LonghornSean

09/19/22 10:14 PM

#151037 RE: wrinklesobw #151033

They mentioned providing monthly updates going through the pre-IDE process on their original LinkedIn post, see below.

Good morning.

Company CEO Mike Korenko is in the process of providing a market update as to where we're at in the Pre–Submission IDE process in regards to RadioGel™ - cancer therapy for Humans. The first one will be out before the end of summer. We will then begin providing general updates on a monthly basis (or sooner), if something substantially changes. Currently we're proceeding on the timeline we've previously established with the FDA.

In regards to IsoPet® - cancer therapy for Pets we're full steam ahead on regional clinic expansion; and shortly, we'll begin an Ad Campaign to further share the awareness of our product to Pet Parents and the #veterinarian community in general.