|>>Would it be too much to conclude that the data is very good and the numbers large enough to support filing for BTD?<<|
No, not too much to ask but I'm hoping IMMU has learned to under-promise and over-deliver. For your reference, when IMMU received BTD for IMMU-132 in the mTNBC indication, there were 60 patients enrolled in that ph. II. That was the first part of the Simon Two-Stage Analysis. The FDA next asked for another 40, or so, patients which got us to a bit over 100, on which the BLA was based. It is also worthy of note that the BTD for those 60 patients (58 evaluable) had a data cutoff of November 10, 2015. Clearly, BTD is but one leg of the run to approval. That said, we do have a lot of data on about 1,000 patients for 132 at this point, so I want to believe things will move along at a quicker pace. What's holding things up on the BTD front, I imagine, is the more recently ongoing recruitment of post-CPI patients in the UTC indication.