"He’s implying that the because phase II trial had relatively few participants, it’s only really a Phase I."
wow, that's a truly idiotic misinterpretation of what I said.
// if they pass futility in a few weeks and the trial runs to the end as is designed and the endpoints are successful, agree it can satisfy NDA.
// If by accelerated approval you mean getting an approval before the end of the full trial based on just proteinuria result, then I reckon chances of that are slim to zero. it's very likely this trial will need to continue for the full 2 year follow up in all roughly 300 patients to get acceptable eGFR results, that's a few years away. if company had provided a recruitment update/forecast in the 4c as they really should have done imo, investors and analysts would have better idea of progress and likely trial completion time.
// and if they don't pass futility in a few weeks and trial folds, hard to see what the future is for this biotech as there is nothing else in their pipeline as far as I can see and this particular dmx2000 asset has no plausible alternative disease to pursue that I can see.
you can call this "trolling" , I really don't give a flying f##k, but this is how I see the situation , and so do others I've consulted on this.
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