I replied to your post above before Whytee came out to ask...

I replied to your post above before Whytee came out to ask people to listen to the recording rather than rely on the transcribed notes, saying he or she “suspected” that Krause had used “efficacy” where you referred to his use of the word “efficiency” in relation to the potency assay.

In fact, after checking the recording myself from the 40 min mark, I realised that the transcribed notes of the CC as quoted originally in your post correctly transcribed the word “effective” but you then went on to refer to Krause saying “efficiency” in your comment that followed - likely a mere typo on your part. Let me reiterate that this is in relation to the potency assay.

So Krause used the word “effective” as did the FDA, in relation to a suitable potency assay’s ability to support evidence for the approval (after having said upfront that in the 2nd CRL, a big positive apart from the inspection in Singapore, was that the FDA did not question the “efficacy” of the product).

Just wanting to note here, that I also then went back to check my first reply to you, to make sure that it is not invalidated by this apparent typo in your post because I was responding to its contents (ie. your reference to “efficiency” rather than “effectiveness”). I just wanted to go on the record on that. I found my first reply still makes sense to me - but people should understand this context if they happen to read my first reply to your above post.

(This is my second reply to the same post.)