nidan7500 Saturday, 03/30/19 03:09:18 PM Re: None Post # of 231286 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm634766.htm?utm_campaign=032919_PR_%20FDA%20Statement%20on%20Expanded%20Access%20–Looking%20Forward&utm_medium=email&utm_source=Eloqua This new information from the FDA expresses a new urgency about EA which I have not seen previously. They are more willing to support risk processes based on REAL DATA (WAHT A CONCEPT).I have (in my own mind) linked this emphasis with FDA Precision Medicine initiatives, while mindful of recent Precision Medicine trials in Oncology. I have also linked this with the AVXL emphasis by Dr.M. on Biomarkers in CNS diseases. He did this long before any competition knew what he was talking about. So, the AVXL trials have been focused on Biomarkers leading our trials efforts, so far, so good. Last week we saw the announced formation of the AVXL (Merck, Sage, other) consortium with a focus on Biomarkers and ERP-AI through a company (Cognision). AVXL has already earlier published an ERP_AI patent for the outpatient use of ERP as a treatment process for AD patients. We also note that Cognision has been granted FDA validation and 510K(K141316) for use as an ERP device in such practices. The patent/partnering w/Cognision presents a non trivial step to Biomarker development in the application of ERP and AI. The FDA (Dr.G.) knew they were going to nuke the remaining AD Amyloid thesis trials. IMO the corresponding birth of Precision Medicine w/links to Oncology successes. The heavy emphasis by Dr.M. on driving trials based on biomarker Precision medicine initiatives and the fact that our trials are similarly structured tells me that AVXL is way out in front. It also tells me the old shot in the dark methods can still produce a winner but will not be competitive. If this were a rifle range Dr.M. is shooting a very tight pattern. So what's next? Consistent with the news released on the 29th by the FDA I would anticipate that future p3 approval trials will be more focused on specific Biomarker endpoint. (eg PDD not only movement but corresponding ERP data). Eventually trials will become much shorter, only long enough to verify that the required patient medical end point is met and the corresponding ERP data have been achieved. This kind of process should lead to EA releases under controlled conditions with patients who are in such a position to move on w/their lives as an outpatient. The days of the , " One size fits all" trials are ending. The technology will evolve over time as AD Dementia holding pens get emptied.