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Wednesday, March 29, 2023 9:00:38 AM
Net, net : he does not want to be far behind the U.K.. Is 2-4 months acceptable to him? Does the FDA have a good working relationship with the MHRA?
Re: marzan post# 581322
Wednesday, March 29, 2023 8:16:50 AM
Post#
581324
of 581349
No one is questioning UK, EU, and Canada approvals. But time is not on our side as we will get diluted like hell before the reimbursements come through in these regions. As a result, the SP will continue to drop and the ramp up in revenue will be much slower than what everyone here expects this year and next.
US is the most important market because it’s almost the same size of all 3 regions combined and typically have higher pricing power. There is no guidance on that (BLA). Anyway, I don’t see any reimbursements coming through this year except UK, and that too if we are lucky!
FDA approval may happen at some point in the second half of 2024, but Tissue agnostic ain’t happening. So stop feeding that BS! It wouldn’t be surprising if NWBO management has been lying to us all along and there was no intention to apply to FDA until the ph 2 combo results are out in early 2024.
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