This draft guidance is wonderful in that FDA reminds us that there has been a long-standing precedent (decades) for use of external controls as "substantial evidence of effectiveness" and approval.

But is it relevant?...

fda.gov/media/164960/d…

$NWBO #Murcidencel Glioblastoma This draft guidance is focused on "patient-level data" which might not relate to #Murcidencel - In that case, FDA would be able to cite the decades old precedent.

Recall that Avastin and Optune were both FDA approved but didn't improve survival in rGBM, unmet need.

$NWBO

Combo data, combo patent.
$NWBO #Murcidencel
$MRK $BMY etc CIs didn’t work, so synergy is *non-obvious*

Further, IF ANYTHING, field was maybe suggesting that neoadjuvant was only place it might work. BUT *unexpectedly* adjuvant works best.

Patentability = war, highly competitive, highly lucrative CI market

$NWBO $MRK #PD1 #Checkpoint