I agree. The final guidelines will be released in December. But the FDA’s internal staff are doing training and seminars on external data and provided support and guidance on the Lancet article. To me it appears FDA is not only on board, but is simply guiding the broader academic and clinical research world as well as their own internal personnel toward what is, in my humble opinion, actually already likely the final guidance just awaiting the final stamp.
As for the manufacturing, the Sawston totals are only 5% of the factory capacity using their shortly to be outdated method of production, the new method, IMHO, after much research, likely to multiply that by at least 10 times. Depends on space requirements and how they deploy that technology and I expect that is just version 1.0 of the commercial Flaskworks technology and likely they will be able to improve on that over time.
I’m not sitting here worried about the FDA or any other regulators not accepting the SAP or that they won’t address the manufacturing challenges. I think they have a plan for it all and that the FDA has likely been guiding them all the way along. I would not be surprised if NIH and others are not all very enthused about this technology coming down the turnpike. All just my personal opinion, but I think it is all just a matter of time now. And obviously, that the unblinded results will exceed or at least match the blinded results we’ve already seen, with my expectation /opinion that they will exceed blinded results.
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