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Re: coldasice post# 10939

Thursday, 11/16/2017 4:16:55 PM

Thursday, November 16, 2017 4:16:55 PM

Post# of 12137
Isn’t that still in phase I? Now, Juno on the other hand . . . .had this little tidbit in their Q3 conference call earlier this month:

Sunil Agarwal (President, Research & Development)

In summary, JCAR017's defined cell composition, with the 4-1BB co-stimulatory domain, represent a unique combination that we believe are 2 key contributing factors to JCAR017's potential best-in-class profile for both efficacy and tolerability.
Moving forward, the pivotal cohort of TRANSCEND is ongoing at dose level 2. We remain on track to complete a BLA submission in the second half of 2018, with an approval as early as 2018. The key variables that may impact our overall approval goal include the time it takes to enroll the pivotal cohort, the timing of our FDA submission and the duration of the FDA review.


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