May. 14 at 10:49 PM
$ADAPY Another one of the last standings bites the dust.
"...Accountable for content and drafting of multiple drug substance/drug product module 3 supportive and compliance sections, and the associated linked consistency with other relevant sections, of the BLA for Lete-cel and IND of next TCR T-cell pipeline asset..."
Two things from the above another indication that the BLA for lete-cel may very well have been submitted already and may be in deep regulatory review. Look at my previous posts where another poster said they had passed regulatory inspection on the facilities (which usually takes place after acceptance of a BLA). Second notice the IND part. So if the main person for the IND is gone who is going to take the drug through clinics hmmmm pretty obvious there is a suitor ready to take over.