Seventh. ElsaSara.......we are three weeks from these calculations on PDD trial progress in Spain and now in Australia....so getting closer to full recruitment. Conjecture would be that most all the patients in Spain have completed full dosing.
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From 9/2 post...add 23 days
"Lets do some math on the PDD Trial.
- 30 OCT 2018, the first person is recruited
- 13 MAR 2019, half or 60 people have recruited (133 days)
- Today is the 172th day since 50% recruitment
- The trial (dosing) is to run 14 weeks or 98 days *****
- The trial has run 305 days (give or take 1 or 2 days....check my math)
Reasonable conclusions:
- We must be at or very near to full enrollment (possible slippage due to the AUS Avatar arm if it includes a portion of the 120 which is not clear).
- A majority, probably over 75%, have completed the initial 14 week dosing and over 50%+ are for sure in the extension portion of the trial, given efficacy.
- IMHO we will see the PDD update in the next couple of weeks...... and a very large amount of data and RWE has been collected and analyzed.
Dosing Adjustment******
PDD timeline adjustment....add an additional 2 weeks prescreening and post 2 weeks safety observation to the length of the individual participant involvement or 98+28 =126 days. There will always be some CRO inefficiencies also, but conclusions remain the same.
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"Detailed Description:
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group, three-arm, 14-week study in PD patients with dementia. The study includes a 2 week Screening / Baseline Observation Period and a 14-week Treatment Period (including a 2 week Titration Period), and a 2-week Safety Follow-Up Period"
