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Friday, January 28, 2022 7:02:25 AM
The clinicaltrials.gov record has just been corrected until now.
The trial has also been POTENTIALLY pivotal for a long time.
I do see the possibility of the 001 and 002 AVATAR parallel and identical protocol low and high dose studies being confirmation of safety and efficacy.
I also maintain that I believe the regulators FDA/TGA/EMA will want to see the paediatric age groups benefiting at least as much for approval.
The rolling NDA is perfect for aligning all the stars for both the paediatric voucher and approval at once with a label for all age groups of Rett patients.
We wait with baited breath for that all important AVATAR readout.
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