These statements are taken from cold hard fkn facts: (At least now you know) - The FDA granted Radiogel BREAKTHROUGH DEVICE DESIGNATION for it's HUMAN treatment Radiogel - The FDA suggested to change their recent IDE Submission to a "Q" Pre-Sub application to allow for additional clarification. - The FDA allowed RADIOGEL to have 5 meetings (ALREADY COMPLETED) over 6 weeks starting on September 13th, once again COMPLETED. - The FDA has requested 3 additional meetings to cover information that the company had anticipated would be addressed post approval.
Opinion: I think the FDA has had all of their initial questions addressed over the 5 meetings described above and are asking for some final details to be addressed for an expedited path to Human Clinical Trials.
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