I think the PW trial suspension was clearly explained and if it has now lapsed into a withdrawal
The reason given on the clinical trial website for the withdrawal of the PWS Phase 2 study is “Revised development strategy”.
Although only Phase 3 PMS was the subject of Neuren’s recent EOP2 meeting with the FDA, Jon Pilcher did state that the company would not only seek a less burdensome safety monitoring protocol requirement for the PMS trial (which the FDA agreed to), but also following, a less burdensome safety monitoring protocol for PWS and any further Phase 2 trials.
The potential benefit for Neuren or partner/acquirer of Neuren is the removal of a barrier to trial recruitment (which should translate to speedier trial recruitment) and possibly a shorter overall trial length (if age group staggering is no longer required). Both outcomes would be highly attractive.
To me, the change on the clinical trials website this week hints that this may now have been achieved. But we will have to wait and see.
NEU Price at posting:
$13.54 Sentiment: Hold Disclosure: Held
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