|There are a few things which were underappreciated along the way which the Daiichi Sankyo news brought back into focus. |
The safety profile of 132 has been really good. Really really good. The 100+ patients in the study used for the AA submission is only a portion of the patients who have been dosed. I'm not sure of the total number at this point which have been evaluated for safety, but it is a lot more than 100. And consistently, there have been no red flags. Or even yellow flags.
Second, IMMU has a lead in certain areas and while it seemed DS (and perhaps others such as SGEN) might be catching up, there is much to be said for having been on the learning curve for a good while.
IMMU is in a position to leverage the accumulated data (example, identifying the proper patient population) and soon, there will be a lot more which gets learned from the ASCENT trial. We're further down the path towards partnerships and combination therapies. Combinations are where the greatest benefit is going to be. And other potential surprises may lurk. Addressing brain mets was mentioned here. I'm not optimistic, but if there really is something there, that'd be quite a coup.
Going forward, IMMU is an execution story. In the long view, they've made considerable progress, despite the setback of the CRL. There's still a lot of potential benefit to IMMU's stakeholders, heavily dependent on their ability to execute.