You keep insisting on comparing apples and oranges. You are...

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vintage

13,521 Posts.

2704

09/12/23

08:14

Post #: 71359087
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Originally posted by vrs37 ↑

why not try reading stuff that's out there, like this
https://www.fdanews.com/articles/20...ttempt-at-accelerated-approval-for-sparsentan
and this
https://ir.travere.com/news-release...etes-successful-pre-nda-meeting-filspari-igan

#trevere completed the largest ever phase3 trialy in fsg called "duplex". better phase2 data than the dimx asset
#excellent statistically significant interim result on proteinuria in phase3. FDA still said no to accelerated. Twice.
#the reasoning is laid bare. only a complete fool with head buried in sand thinks none of this is relevant
#what's so special about the dimx asset that make you think FDA will give them free pass to accelerated? I just don't see it. other ccr2 inhibitor from CSL failed in its fsg trial, no better than placebo
https://newsroom.csl.com/2020-05-18-VFMCRP-Press-Release-Phase-ii-Lumina-1-Trial-of-Ccx140
#question if this method of action is that effective in fsg disease but we'll know for certain once dimx phase3 finishes in few years

You are so clueless, it is embarrassing!

You keep insisting on comparing apples and oranges. You are wallowing in the wrong paradigm.

It is not about the size of the trial or the relationship between the phase 2 and 3 outcomes of a totally different drug. It is entirely about how the DXB-200 molecule performs in the Phase 3. If it achieves the trial endpoints, then accelerated approval will be a given. If it doesn't, like Travere, it will not get the approval. Simple.

I would think that most here suspect why you lack even-handedness and are trying so persistently to sew doubt about this trial. It's not altruism.

You keep insisting on comparing apples and oranges. You are wallowing in the wrong paradigm.

It is not about the size of the trial or the relationship between the phase 2 and 3 outcomes of a totally different drug. It is entirely about how the DXB-200 molecule performs in the Phase 3. If it achieves the trial endpoints, then accelerated approval will be a given. If it doesn't, like Travere, it will not get the approval. Simple.

I would think that most here suspect why you lack even-handedness and are trying so persistently to sew doubt about this trial. It's not altruism.

Expand

You keep insisting on comparing apples and oranges. You are wallowing in the wrong paradigm.

It is not about the size of the trial or the relationship between the phase 2 and 3 outcomes of a totally different drug. It is entirely about how the DXB-200 molecule performs in the Phase 3. If it achieves the trial endpoints, then accelerated approval will be a given. If it doesn't, like Travere, it will not get the approval. Simple.

I would think that most here suspect why you lack even-handedness and are trying so persistently to sew doubt about this trial. It's not altruism.

Last edited by vintage: 09/12/23

DXB Price at posting: 13.5¢ Sentiment: Buy Disclosure: Held
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