this is actually what has been happening, confirmed by today's PR. MHAR would not inspect a manufacturing facility for readiness and then issue a certificate unless it has reviewed application/request or at least TLD
This is getting stupid.
The GMP certificate (which still likely a year away) says nothing about the product they are manufacturing. Says nothing about it being ready for approval.
Cognate had GMP certification over a dozen years ago. Did the FDA already review the NWBO BLA then?
All this says is that NWBO is one step closer to being the contract manufacturer LP is going for.