Replies to post #189436 on Biotech Values

[biomaven0]

Well the Fibrogen IPF data clearly show a correlation between HRCT and FVC:

After 48 weeks of treatment, twelve of the 33 patients (36%) had improved fibrosis as measured by quantitative HRCT. Prior to this finding, improved fibrosis had never been reported in IPF patients. An additional two patients had stable fibrosis for a total of 14 patients (42%) with improved or stable fibrosis.

Change in forced vital capacity, or FVC, also correlated with changes in fibrosis (p=0.005, r= -0.476) at 48 weeks. Patients with improved or stable fibrosis also had improved pulmonary function at week 48 with FVC change of +0.05 liters compared to -0.24 liters for patients with worsening fibrosis (p=0.006).

But I suspect the FDA is still a long way from accepting HRCT as a valid endpoint that would be enough on its own for approval.