Thursday, November 04, 2021 10:14:59 AM
No. What I can say is that he was clear that several items are out of their hands and they are jumping through hoops to respond asap when asked for additional info. That would be regarding data review and Journal I would imagine. The connect the dots game was discussed again. Paraphrasing, but some of the questions and "dots":
Ask yourself WHY we would be doing things that we are doing?
Sawston build out and certification?
Did you read the Lancet article RE: external control arms? Who was involved in writing that? (Tim Cloughesy/UCLA)
Have you been listening to LL when she has spoken recently?
Is it faster to get RA approval if you have manufacturing in place and certified?
What would we have to do if we knew we had bad results in hand?
So, nothing new really. Not going to PR anything but Material info and milestones until TLD/Journal. HTA was PR'd, MHRA may be PR'd. Still no idea on timing, which is why I believe first quarter, I hope I am wrong.
Ask yourself WHY we would be doing things that we are doing?
Sawston build out and certification?
Did you read the Lancet article RE: external control arms? Who was involved in writing that? (Tim Cloughesy/UCLA)
Have you been listening to LL when she has spoken recently?
Is it faster to get RA approval if you have manufacturing in place and certified?
What would we have to do if we knew we had bad results in hand?
So, nothing new really. Not going to PR anything but Material info and milestones until TLD/Journal. HTA was PR'd, MHRA may be PR'd. Still no idea on timing, which is why I believe first quarter, I hope I am wrong.
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