Welcome to the Age of Alliances in medical research
Agree and lets make a special note that this new alignment will introduce the next stage of FDA trial process evolution. The Roth panel discussion w/Dr.M. and the panel moderator's comment told us all we needed to hear. Amyloid thesis is dead, long live...they threw dirt on the BIIB trial and there was not a dry eye in the room.
Precision medicine must have the next level of science in order to resolve complex markers and indications in CNS, LIKE AD. Obviously DR.M. would have been sitting there knowing what the future trials will look like. The existing model is based on basics in the scientific method but w/o an appropriate level of science detail. We must/will have a CNS trials model similar to that developed for Oncology. This technology and related thinking is the beginning of that transition.
This new partnership will change what and how critical markers are measured in CNS trials going forward. The application of ERP science and AI tools will revolutionize FDA trials and rewrite the books, long overdue. IMO, this is why Dr.G. walked away from FDA and it is only just the beginning of a trials process makeover.
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