Senti do you have any link regarding this "specialist" or wish to disclose how you know this ? Otherwise, we simply do not know who Les was talking about. It could be argued that such a specialist you refer to is the reason why they pay the SAB.
I do think they have a special advisor that has written numerous and oft used FDA regulation text books and whom is considered a strong authority on the subject. I’d imagine LP listens intently to what this expert has to say regarding data lock, and consults his input as to when it might finally be the right time to move forward with that important milestone.
Victoria (Tory) Lake?
Victoria (Tory) Lake, RAC
Regulatory Affairs Consultant at Sound Regulatory Consulting, LLC