It was confirmed in the quarterly report released this week that the Phase 3 trofinetide trial is still on track to report results by the end of next year.
Sixteen centres are now recruiting in the main trial, which was the minimum number of locations planned by Acadia before commencement of the trial. Two of these (Seattle, Washington and Philadelphia, Pennsylvania) were added this month. Ten months after the unblinded extension trial commenced, there are now nine recruiting centres listed, but this list has not been updated since July.
The US clinical trials website indicates that collection of data for primary outcome measures will be completed by next September and for all other outcome measures by October. That means that if the trial remains on track, completion of enrolment in the main Lavender trial should be announced by next June.
Next week marks one week since first enrolment and we are now past the halfway point in this trial. If I was wanting to make a move on Neuren prior to the release of the Phase 3 trial results, I’d probably make it by next June – still 6 months away from results, prior to NEU's commencement of its three Phase 2 trials in NNZ-2591 and prior to any meaningful advancement of a fourth NNZ-2591 indication. I’d be wanting to avoid lobbing my bid against a background of lifting shareholder sentiment accompanied by a lifting shareprice.
Of course, this is just my (cynical) view.
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- Ann: Quarterly report and cash flow statement for Q3 2020
Ann: Quarterly report and cash flow statement for Q3 2020, page-24
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