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Posted On: 06/04/2020 2:51:57 PM
Post# of 153905
Quote:It's kind of interesting, but I really didn't fully understand the relative timing of the US/Mexico trials until I drafted my most recent catalyst list.
Mexico and other countries will want Lero. If Dr. Terán is designing the trial with only 25 patients for the severe to critical. I’m sure the results of the M2M will be more than enough proof for him.
As others have posted, I agree that the FDA probably won't receive clean P2 Mild-Moderate trial results until the second week of July, at the earliest. Same goes for the P3 Severe-Critical 50-Interim results. In both cases, that's ~6 weeks from now.
Meanwhile, I project the following for the Mexican trial:
- Protocol approval within 1 week
- Full Enrollment 2-3 weeks
- Interim Results 4 weeks later
- Data Scrubbing 1 week
Obviously, each of these durations can be compressed (except the 28 days), but it looks like Mexico won't be in a position to approve for ~8-9 weeks.
I had been operating under the assumption that all three trials would culminate at around the same general time.
However, with this timeline, I'm not quite sure how much leverage the Mexico trial actually represents in terms of motivating the US FDA to approve.
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