I believe Flaskworks is actually moving/timed up with publication as there might be 2 training centers engaged right now. Sawston and Charles Rivers Labs which put out comments recently that Cognate and others are now fully integrated into their system. That means manual system know how and likely Flaskworks integration preparedness in my opinion. I’m with you that the overhead can’t be carried very long and that comparability studies must be near their ending point because a rich guys only Specials program isn’t going to cut it for very long after news. Once publication and top line data are released patients will become aware very quickly and demand will soar and the demand to have it immediately approved and be reimbursed by insurance will be just about as immediate. Put children into the mix and you have some major fireworks brewing. This is it. End of the line for stalling once news hits because safety has never been an issue. It’s be ready or get run over. The new hires getting trained at Sawston and I believe Charles Rivers Labs too are not there to sit by idly waiting on a regulatory green light either. We’ve been on a stale red for a really long time and manufacturing readiness has got to be the key that turns everything loose which suggests to me that the Flaskworks green light is about to be given. The last piece before an announcement has to have been integrating Flaskworks pre approval to be able to meet the high rate of expected demand and relieve the pressure on everyone from it. Reimbursement can probably be looked at on a chart based on inflation adjusted quality life years after all this time. I sure hope regulators are ready to approve in less than 6 months from release of the journal article and top line because I wouldn’t want to be working in an office with a bunch of angry folks waiting for me outside. I’m guessing between now and March. Regulators can be very quiet when they need to be and in my opinion they have been with NWBO because of what’s at stake. Best wishes.
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