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Re: ae kusterer post# 573886

Tuesday, 03/07/2023 9:41:09 AM

Tuesday, March 07, 2023 9:41:09 AM

Post# of 705410
I don’t think FDA approval is likely this year. There is no commercial manufacturing infrastructure in the US yet. They have opened up contract negotiations but these things take time. I doubt we will see BLA submission until Q3/Q4 at the earliest. And that puts FDA approvals around mid next year.

I don’t think a buyout is coming anytime soon. If a big pharma was already talking to NWBO and a deal was in the works (pending approval) they would have handled US manufacturing differently. NWBO wouldn’t have started discussions with US CDMO as they indicated in the last report. Big pharma would want to use their own manufacturing facilities for quality control, IP protection (Flaskworks), and margins. My sense is buyout will take a while. NWBO will have to consistently prove that they can scale and be profitable over a few quarters before a big pharma jumps on it.
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