Before the April expiration we should almost certainly hear news on the peek at the data in the Phase 3 for IMGN853. I don't believe it will go beyond a recommendation that the trial continue, but I'm not certain more won't be revealed. Regardless, just the confirmation it should happen ought to be positive for the stock.
While I believe the results in combination are better, I would hope that approval could come from the monotherapy approach the FDA demanded. With the new FDA Commissioner pushing for faster approvals, I'm not certain that one of the Phase 2 Trials, perhaps expanded, couldn't be used for faster approval than the conclusion of the Phase 3. Because of the way the Phase 3 is structured, I don't believe that it would be shortened.
In my treatment for leukemia, I would hazard to guess that about 40% of the time I was on drugs that might be considered as off label applications which were labeled for other forms of leukemia. I believe that's true for many cancer treatments.
Gary
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