Wednesday, November 06, 2024 10:23:23 AM
That it has been slow is a fact. Had they submitted to the FDA in late Dec and been given a priority review the PDFA date wold have been late June. The FDA has been fairly regularly meeting the date, and often ahead of schedule. Resources matter.
Exactly. There is simply no comparison. To say they submitted to the MHRA because of timeline concerns is just false.
If NWBO thought the FDA would approve, a BLA would have been submitted by now.
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