1) This to me reeks of alpha error – where in TENX by chance has found one notable signficant metric in a small study by virtue of testing for enough of them. -> this is true, but what i the delta excluding the three outliers? and how does the KOL commentary about the OLE change any opiniion if they have 1/2 outliers in the ph3.
2) "Levo is dilating the pulmonary vascular system and increasing pressure." -> which hemodynamic data for this? and what do you make of the PCWP reductions unlike the prior selective mPAP reducers (the PAH drugs)
3) what do you think about the splanchnic volume argument, similar to the APEX HF trial with Splanhcnic nerve ablation?
4) "select only responders of the drug, which enriches the results dramatically" ->95% of Ph3 continued into OLE. the prior ph2 selected out 20% of patients.
I don;t think the readout is without risk.....But to cite mPAP reductions as why it fails doesn't seem like the right bear thesis.
it's also PH, not PAH for Group 2. PAH is group 1. and I would segment ipcPH vs cpcPH because of the sotatercept, relaxin, PAH drug data out there.