2023 The Final Countdown, page-1620

Alright @whytee

fixed according to your "interpretation" but without the biased rhetoric and waffle.

• Potency assays defined as reasonable.
• Significant new data filed.
• BLA resubmitted
• BLA resubmission ACCEPTED
• No 483 form meaning no significant issues identified at the facility inspection
• Last communication from MSBthe CEO of MSB regarding the submission is that labelling is the only labellingmajor item left to discuss outstanding.

"The major thing that still remains is the completion of the review and the decision whether or not to give approval."

uh-huh.

Are you genuinly making that argument - or are you just arguing for the sake of arguing now?

But to play along i'll ammend the above:

• Last communication from MSBthe CEO of MSB regarding the submission is that labelling is the only labellingmajor item left to discuss outstanding... major item outstanding within the review process for the those amongst us who struggle with simple comprehension.