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Re: KRISGO post# 763792

Thursday, 04/24/2025 5:36:34 PM

Thursday, April 24, 2025 5:36:34 PM

Post# of 776763

Honestly, I’m feeling pretty nervous too

so do I. perhaps some info to lighten your evening a little bit (I hope)

In most cases (actually ALL cases), when the MHRA (or EMA/FDA) raises serious issues with an MAA, especially late in the process, companies will proactively withdraw the application rather than receive an outright rejection.the fact that Northwest Biotherapeutics (NWBO) hasn’t withdrawn their MAA after over 16 months despite already going through the full inspection and RFI process is a positive signal.
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