$DFFN Management has really tested retail patience here but let’s see if we can build some momentum before the next covid-19 related PR(s). Here’s my approximate timeline for the coming weeks/months: Q2/3 2020: •European Phase 1A/1B clinical trial approval (late June). •Initiate European Phase 1A study of 24 patients (late June/early July). •US IND submission (late June/early July). Q3/4 2020: •US IND approval (late July). •Data from 24 patients in Phase 1A of European trial (Aug/Sept). •Initiate US Phase 2 trial (Aug/Sept). •Initiate European Phase 1B study of 200 patients, double-blinded study (Sept/Oct). Q4 2020 •Interim readout on 50 patients in European Phase 1B (Oct/Nov). Q1/2 2021: •Enrollment completion of 224 patients in European study (Jan-March 2021). •Final data readout of 224 patients in European Phase 1A/1B trial (April-June 2021). I didn’t include many US trial dates bc I don’t know much until the actual IND is filed in the coming weeks. GLTA.
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@TarekMorad looks good except for FDA submission will come after data from the initial 24 patient study. In the stockholder meeting it was stated that they want to have as much data as possible before seeking FDA trial approval. Otherwise, your timeline is pretty accurate I'd say.
@Pepmechanical yeah and he also reiterated in that same meeting that fda IND submission should be by end of the month so I’m giving some slack and estimating submission into early July. I’m sure it’s an adaptive-design like their proposed phase 1B is in Europe so they can adjust accordingly.