Jonjones, I was at the meeting as well (tall guy in front/closest to Dr. Missling as he presented). I was curious if anyone had followed up on this myself. Toward the beginning of his presentation, I believe while he was still taking a few initial questions, he spoke about the fact that there would be multiple age groups enrolled in the trial then followed up with a statement that they were working with the FDA on "how to start the study with existing toxicology (data)..."
This left me with the same question that Steady_T posed and the feeling that there MAY still need to be a study done. My in-the-moment thought (and uninformed guess) was that maybe they were looking at first enrolling those patients who are old enough to satisfactorily be covered by existing data while completing the juvenile tox study. I had intended to follow up on this in the after meeting conversations, but forgot to in the midst of other discussions.
Anyhow, very positive meeting all around and it was great to have such extensive access to the team.
Also I have to mention, the wrap up and thoughts you shared with the board were fantastic and IMO absolutely spot on with what transpired. Thank you!
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