TGTX: I should expand on a couple of the bear case points, that make it less conjectural:
1) The slow enrollment meant not only reduced power, but forced a change in endpoint from PFS to response rate. This voided the SPA. While the FDA has approved similar regimens on response data without SPAs, there is now more uncertainty wrt to how good the data would have to be to garner approval.
2) Given the quick uptake of Imbruciva in these indications, and the also widespread use of anti-CD20 drugs, many patients won't be naive to those, and oncologists might try a combo with at least one MOA the patient is naive to. As such, even on good response and safety data, market penetration could be sketchy.
As such, one take is that the Genuine trial is more important as an early read on the Unity trial. Poor results would likely erode well confidence in Unity, rightly or not.
Regards, RockRat
