Schaber has mentioned a figure of up to $200mm globally for the Orbec market in prevention and treatment combined. The DORB factsheet says there are 20,000 addressable transplants between US and Europe and appears to assume 50% penetration. So that's $20,000 per transplant. The value of improved chance of survival and reduced chance / duration of excruciating GI symptoms, steroids and hospitalizations, may well justify such a price. I would think that if they show strong survival benefit, the number of transplants may rise, since high mortality from GVHD has (in the '90s - not sure if still the case) been a reason for not viewing transplants as acceptable therapy.
My view: the mkt cap is so low ($15mm latest) that it prices in no serious Orbec revenue at all. So even if $200mm is way bullish, I'm not worried. As Schaber says, this is not an expensive market to reach, since the transplant world is highly concentrated and they all talk to each other. So as I recall the royalty applies to US sales, which would be about half the total. But DORB won't have too hard a time capturing the European and ROW sales, and of course their compassionate use (or similar) program in many countries is already creating the market.
As to the value of the prior trials, maybe Dew or Clark can remind us what the legit objections were. One I recall was that the patients were collected over a very long period and the nature of therapy maybe changed over the course of the trial, so there were apples and oranges problems. That said, you can tell from the advisory panel that even the dreaded Pazdur thought the drug worked and he postured as looking for a way to bring it to market, since the unmet need is clearly dire.
A very close friend of mine, myeloma pt, barely survived post-transplant GVHD and had a miserable 18-24 months of steroids, infections and all the rest - though a miraculous 11 years and counting of life - so I declare a dangerous (from an investing pov) emotional bias in favor of Orbec.
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