Question… did we hear today about completing the safety aggregate? Didn’t they say the audit was complete and that they were going to ask the FDA for a “C” meeting?
We went passed the 12 week restoration of our trials that was predicted by Dr. Kelly to be 8-12 weeks and our trials should be rolling. I am paraphrasing now. Dr. Kelly thought the safety of Leronlimab would be complete and everything back to rolling right along in 8-12 weeks. But he didn’t figure that we were expecting quicker response from the FDA and probably was ignored again.
Unless I missed something. The “C” meeting was to get our safety aggregate approved to move everything forward. Can anyone confirm that or was the “c” meeting for something else entirely? I might if drifted off at all the excitement I wasn’t feeling from the call. TIA.
We went passed the 12 week restoration of our trials that was predicted by Dr. Kelly to be 8-12 weeks and our trials should be rolling. I am paraphrasing now. Dr. Kelly thought the safety of Leronlimab would be complete and everything back to rolling right along in 8-12 weeks. But he didn’t figure that we were expecting quicker response from the FDA and probably was ignored again.
Unless I missed something. The “C” meeting was to get our safety aggregate approved to move everything forward. Can anyone confirm that or was the “c” meeting for something else entirely? I might if drifted off at all the excitement I wasn’t feeling from the call. TIA.
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