Theratechnologies Inc T.TH

NASH NITs vs Biopsy discussion

[qwerty22]

https://surfingnash.com/s2e36-ilc2021-wrap-up-big-issues-key-takeaways-remaining-issues/

This conversation is great. You can skip the first 5-10mins of folky stuff (don't be put off by it).

This is a bunch of academics, clinician and industry people.

The NIT vs Biopsy discussion is great. The extraordinary frustration with the regulators lack of movement away from biopsy is real. The belief that NITs (non-invasive tests) are ready to take over from biopsy is almost there. Presumably with a further meta-analysis of all the recent (failed) trials might be all that is needed to get these things over the bar. Seems like most of the NASH community is ready to move on but the regulators remain the roadblock. I'm pretty convinced external advancements like this would be great for THTX's program. If it had happened in 2020 we would be in a better position. We are looking at internal changes that might improve the company but externals could also have a big impact.

[longterm56]

Is there any chance at all that this might be a reason for THTX taking so long to finalize their protocol?  Can I dream that they are negotiating this with FDA and it is taking a long time for them to get all the details correct for such a major shift?  Or would there be more press/conversations/papers/KOLs involved with such a discussion.  Remember, there is a lot of safety data on

[Lee430]

Great! I was hoping someone else would toss this possibility out there, it sure has been bouncing around in my head for some time, seems to be a real stretch but who knows maybe it’s possible?