Jack, TLD doesn't in any way reflect when regulatory approval is achieved, that's based on when the BLA is submitted, and approved. I believe the company is concentrating on the BLA, Dr. Liau is concentrating on a Journal publication, and TLD is something that all may have agreed to tie to when the publication will occur.
The company in preparing the Sawston facility for manufacturing is doing what's necessary for an approval, it won't happen if the company can't supply the product in commercial quantities. CRL may very well have similar inspections, or may already be qualified, that story hasn't been fully told, but it certainly should have the capabilities needed.
This was a very complex trial, the TLD statement is normally only a few paragraphs long, it's not in very much detail. If that TLD statement had been issued many months ago, even if it sounded quite positive, with very little detail, bashers could easily ask questions which couldn't be answered until peer reviewed technical information had been presented. By waiting for a Journal the company is leaving little, or nothing, for bashers to try to build a case on. Nearly everyone would have liked to have had TLD months ago, but the company is probably very wise in not opening themselves up for many months to shorts who'd love to create doubt. Remember, it's the BLA that leads to approval, the TLD has nothing to do with it.
Gary
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