$CAPR just shooting the breeze here. I feel inspire has got nothing to do with dmd aa or P3 decision. Co wouldn’t have Inspire data lined up in Q3 if that were the case with fda deadline by Linda also coinciding in the same qtr. So if inspire is truly an independent lever, in theory there is nothing holding back fda until Q3 to give an AA decision to Linda. Remember Q3 deadline is from co to fda - fda need not wait to green light bla filing. Current unknowns are - ole trial data and fda feedback to co - all those statisticians and advocacy groups that Linda is working on to continue to make the case for AA - long term data from control arm of Hope 2 and how they’re trending - inspire safety data since dsmb already green lighted it back in dec Ideally, they get green light to file BLA. Clock starts ticking. Stock takes off, Linda uses S3 to hire folks, Lonza is already lined up since cGMP will be portion on bla. That’s why Lonza has been lined up ahead of time.
@rogertrades I must have missed that in the ER, however if in fact they were looking at overall safety of cap1002, there was also this. You certainly can be right, I just don’t understand why wait a year if they (fda) didn’t want some sort of additional data!