The video by Robert Barnes, explains the BLA...

Basically he explains that the BLA is giving authorization to a product that is NOT even manufactured yet, while at the same time making it seem what's out in the market is what's covered by this BLA. He also says, whatever is approved on this letter, will not be rushed to be manufactured as it might be "eligible" for lawsuits.

Driving so can't really type and transcribe, but there is a section of the letter that says:

the pharmcovigilance the fda is required to maintain under section 505(k)3 of the FDCA, is not sufficient to assess these serious risks.

Therefore you're required to conduct the following studiets...and it goes to list a bunch of studies with dates from 2022 til 2025...

Bottom line, legal language to fool the sheep!!!

[link to vivabarneslaw.locals.com (secure)]