/biz/ - Business & Finance

>>55476568

So you're picking up on a fact pattern that I noticed too: why weren't any of these marked as treatment related?

I still think their worse AEs leads to underpowering issues. They're powering for 20% placebo and 70% active arm responder rates.
In a trial of 56 patients, modeling dropouts correctly the stats can make your readout a lot milder (which is my base case rn, that the P3 readout hits but is not differentiated from competitors).

> sincerely doubt the P3 trials will be that disappointing.
My thesis is not that the P3 trials will MISS or be cleanly NEGATIVE, it's just not going to be nearly good enough versus competitors

Look more into CRNX data and their competitor, Mycappsa, and another R&D phase acromegaly drug from the Swedish company Camarus. A couple weeks ago Camarus reported 38% pbo response at week 24. Bodes poorly for CRNX.

Mycapssa is the standard of care for oral and Mycappsa's 58% response rate was viewed as a disappointment, though it was consistent with other acromegaly pivotal studies

Even though Mycapssa has consistently shown an ability to maintain IGF-1 levels >1x ULN, patients often saw an absolute increase in their IGF-1 levels while on Mycapssa in both OPTIMAL and MPOWERED versus the level maintained on injectables.

I would assume pic related is why they upped dosing. Is odd that it doesn't align w/ pk.

I think the Phase 3 trial actually hits but the stock still goes down. I think acrogelamy is a small market anyway and my base case is trial hits but just not differentiated from mycapsa, which imo sends it down to low mid teens. That is why CRNX is a short.

It's not that the Phase 3 trials miss their endpoint cleanly, but that the data isn't good enough for the market to warrant it a commercial success in a competitive acromegaly market.