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Saturday, December 02, 2023 5:28:07 PM
Direct will move to the forefront much faster than you think. Manufacturing and product release issues for Direct have already been dealt with because of L so no holdup there and that has been a major holdup for L.
Proteomics will move Direct forward very quickly as biomarker correlation to survival is already strong and will likely be used to speed up the trial(s) as well as the fact that tumors will completely die or disappear within weeks to months. A trial may be followed long term but stopping early for efficacy is highly likely and patients will be clamoring for this. So no, I don’t believe what happened will just be forgotten nor do I believe that it will take many years to validate Direct. The evidence is everywhere that Direct trials will be short. Best wishes.
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